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PubMedDate not supplied

Hypothalamic-pituitary-adrenal axis suppression and inhaled corticosteroid therapy. 1. General principles.

The safety of long-term inhaled corticosteroid therapy at commonly prescribed doses is an issue of growing concern to physicians and international regulatory bodies. This is so because long-term use of these drugs has become the mainstay of chronic asthma management and their introduction now is widely recommended in official treatment guidelines at the 'mild persistent' stage of asthma, where regular daily therapy is first begun. In addition to more frequent use of inhaled corticosteroids, there is a further trend to use higher doses of existing inhaler therapies and to use the newer and more potent compounds that have recently become available. At the same time as these developments have been taking place, there has not been a concurrent move to a more rigorous examination of the safety profile of these inhaled corticosteroid treatments - especially to assess their effects on the hypothalamic-pituitary-adrenal (HPA) axis. Most safety data with respect to HPA axis effects have been derived from testing methods that are limited in their ability to detect HPA system impairment and, more seriously, that can give the impression of functional integrity in the HPA axis when there may be moderate (or even greater) impairment. In this first part of a two-part review of the HPA axis effects of inhaled corticosteroids and of how these effects should be assessed, we examine the currently used and the currently available testing methodologies and also review the present state of knowledge concerning the structure and function of the HPA axis and the effects of its suppression. It is clear that there are state-of-the-art tests to assess in a discriminating manner the safety profile of inhaled corticosteroids. These tests have been insufficiently employed, including during the drug development process, yet they are readily available, relatively inexpensive and can detect adrenal suppression before the appearance of clinical effects. In part 2 of this review we examine what can be learned about the effects of inhaled corticosteroid therapy on the HPA axis from the limited amount of reliable published information from clinical and pharmacological studies describing their use and safety.

Administration, Inhalation↗
PubMed2002

Steroid inhaler laryngitis: dysphonia caused by inhaled fluticasone therapy.

OBJECTIVE: To describe a condition that is referred to as steroid inhaler laryngitis, a clinical entity that is caused by the use of inhaled fluticasone propionate and manifested by dysphonia, throat clearing, and fullness. DESIGN: Case series. SETTING: An outpatient clinic of an academic referral center. PATIENTS: The study population consisted of 20 patients with reactive airway disease and dysphonia who were receiving inhaled fluticasone therapy and who were diagnosed as having steroid inhaler laryngitis during the period from January 1998 to June 2000. INTERVENTION: Cessation of inhaled fluticasone therapy when possible, as well as treatment of other underlying causes of dysphonia, such as laryngopharyngeal reflux and infectious processes. MAIN OUTCOME MEASURE: The resolution of dysphonia with cessation of inhaled fluticasone therapy. RESULTS: Patients with steroid inhaler laryngitis were found to have laryngeal findings ranging from mucosal edema, erythema, and thickening to leukoplakia, granulation, and candidiasis. Patients with more severe mucosal findings were more likely to have laryngopharyngeal reflux as well. Resolution of dysphonia occurred only after discontinuation of the inhaled fluticasone therapy. CONCLUSIONS: Steroid inhaler laryngitis is a form of chemical laryngopharyngitis induced by topical steroid administration. Symptoms and physical findings mimic laryngopharyngeal reflux, but only respond completely to discontinuation of the inhaled steroid therapy. The otolaryngologist should be familiar with this cause of dysphonia.

Administration, Inhalation↗
PubMed1987

The mechanism of corticosteroids in treating asthma.

It would be difficult for physicians or allergists to imagine doing without corticosteroids in managing difficult cases of bronchial asthma. It is beyond any doubt that CS act on many sites to help reverse the pathologic process of bronchial asthma. Corticosteroids enhance the beta-adrenergic response to relieve the muscle spasm. They also act by reversing the mucosal edema, decreasing vascular permeability by vasoconstriction, and inhibiting the release of LTC4 and LTD4. Corticosteroids reduce the mucus secretion by inhibiting the release of secretagogue from macrophages. Corticosteroids inhibit the late phase reaction by inhibiting the inflammatory response and interfering with chemotaxis. This action may be due to the inhibition of LTB4 release. The eosinopenic effect of corticosteroids may help to prevent the cytotoxic effect of the major basic protein and other inflammatory mediators released from eosinophils. Corticosteroids have no effect on the immediate hypersensitivity reaction and have no direct role in bronchial reactivity. By blocking the late reaction, they prevent the increased airway reactivity observed with late bronchial reactions. The limitation of using corticosteroids are their side effects. They vary from tolerable to life threatening side effects. Each tissue in the body is a target for corticosteroids. The mechanism of adverse effects have been studied in extensive detail but many questions are yet to be answered. Alternate-day therapy and inhalation therapy are meant to minimize these side effects. The expansion of using inhaled steroid therapy and finding some inhaled preparations that have even less systemic side effects seems a reasonable approach to deal with severe asthma.

Adrenal Cortex↗
PubMed2000

Inhaled glucocorticoid therapy in infants at risk for neonatal chronic lung disease.

The primary impetus for the study of inhaled glucocorticoid therapy in the treatment and prevention of neonatal chronic lung disease (CLD) was to achieve effective anti-inflammatory therapy with few adverse effects. Initial reports of inhaled glucocorticoid therapy in infants with established CLD suggest modest improvement in neonatal respiratory outcomes. Recent randomized trials also indicate that inhaled glucocorticoid therapy may provide some benefit, but have not demonstrated a reduction in CLD. Some studies suggest that the pulmonary response to systemic glucocorticoid may be greater and faster than response to inhaled glucocorticoid therapy. Few adverse effects have been noted with inhaled glucocorticoid therapy. One limitation of studies of inhaled glucocorticoid therapy is the uncertainty of the dose delivered and deposited in peripheral airways and regions of the lungs. Experience with and systematic study of inhaled glucocorticoid therapy is still in its early stages. The role of inhaled glucocorticoid therapy in the treatment and prevention of CLD is evolving. Advances in delivery devices and new developments of drug formulations should improve aerosol delivery and deposition in infants. Given the clinical dilemma of systemic glucocorticoid therapy and potential benefits demonstrated by recent trials of inhaled glucocorticoid therapy, further study of inhaled glucocorticoid therapy for CLD is warranted.

Administration, Inhalation↗
PubMed1999

Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia.

BACKGROUND: The safety and efficacy of inhaled glucocorticoid therapy for asthma stimulated its use in infants to prevent bronchopulmonary dysplasia. We tested the hypothesis that early therapy with inhaled glucocorticoids would decrease the frequency of bronchopulmonary dysplasia in premature infants. METHODS: We conducted a randomized, multicenter trial of inhaled beclomethasone or placebo in 253 infants, 3 to 14 days old, born before 33 weeks of gestation and weighing 1250 g or less at birth, who required ventilation therapy. Beclomethasone was delivered in a decreasing dosage, from 40 to 5 microg per kilogram of body weight per day, for four weeks. The primary outcome measure was bronchopulmonary dysplasia at 28 days of age. Secondary outcomes included bronchopulmonary dysplasia at 36 weeks of postmenstrual age, the need for systemic glucocorticoid therapy, the need for bronchodilator therapy, the duration of respiratory support, and death. RESULTS: One hundred twenty-three infants received beclomethasone, and 130 received placebo. The frequency of bronchopulmonary dysplasia was similar in the two groups: 43 percent in the beclomethasone group and 45 percent in the placebo group at 28 days of age, and 18 percent in the beclomethasone group and 20 percent in the placebo group at 36 weeks of postmenstrual age. At 28 days of age, fewer infants in the beclomethasone group than in the placebo group were receiving systemic glucocorticoid therapy (relative risk, 0.6; 95 percent confidence interval, 0.4 to 1.0) and mechanical ventilation (relative risk, 0.8; 95 percent confidence interval, 0.6 to 1.0). CONCLUSIONS: Early beclomethasone therapy did not prevent bronchopulmonary dysplasia but was associated with lower rates of use of systemic glucocorticoid therapy and mechanical ventilation.

Administration, Inhalation↗
PubMedDate not supplied

Effect of inhaled steroid therapy on distribution of Tc-99m DTPA radioaerosol in asthmatic children.

The aim of this study was to evaluate the effect of inhaled steroid therapy on the distribution of inhaled Tc-99m DTPA in asthmatic children. Twenty-one asthmatic children and 15 healthy controls were entered in this study. The distribution of radioaerosols was scored by using a modified standardized score system over both lungs and expressed as homogeneity score/patient. The baseline homogeneity score was calculated before the inhalation therapy of budesonide (400 micrograms/day) for six months. The homogeneity score was repeated at the end of the second and sixth months of therapy. Asthmatic symptom scores and peak-flow rate variability, which were observed to improve throughout the study, were also recorded. Although homogeneity scores of the controls demonstrated no abnormality, mean baseline homogeneity scores of asthmatics was significantly high, 1.7 +/- 0.4/patient, and decreased to 0.6 +/- 0.2 and 0.3 +/- 0.1/patient at the end of second and sixth months, respectively (p < 0.05). These results revealed significant improvement in the radioaerosol distribution after inhaled steroid therapy. It was concluded that the lack of homogeneity in the distribution of Tc99m-DTPA in the lung, as an indicator for ventilation defects, may be accepted as a useful, noninvasive tool to monitor the efficacy of the therapy with inhaled agents in childhood asthma.

Administration, Inhalation↗
PubMed1995

Bone mineral density and the risk of fracture in patients receiving long-term inhaled steroid therapy for asthma.

To determine whether high-dose or prolonged inhaled steroid therapy for asthma increases a patient's risk of osteoporosis and fracture, we measured bone density in 26 men and 43 women (41 postmenopausal, all of whom had received supplemental estrogen therapy) after treatment with an inhaled steroid for 10.1 +/- 5.5 years and oral prednisone for 10.7 +/- 9.7 years (mean +/- SD). Most had stopped receiving prednisone since commencing the inhaled steroid therapy. We found that bone densities (adjusted for age and sex to yield a z score) were lower in association with higher daily doses of inhaled steroid (p = 0.013 ANCOVA) and with the duration of past prednisone therapy (p = 0.032). Larger cumulative inhaled steroid doses were associated with higher bone densities (p = 0.002) and a reduction in the numbers of patients at risk of fracture. Bone density also increased with the amount of supplemental estrogen therapy (p = 0.058) and, at equivalent levels of inhaled and oral steroid use, women showed higher bone density z scores than did men. Women with a lifetime dose of inhaled steroid greater than 3 gm had normal bone density regardless of the amount of past or current prednisone use or the current dose of inhaled steroid. These data indicate that the daily dose, but not the duration, of inhaled steroid therapy may adversely affect bone density, and that estrogen therapy may offset this bone-depleting effect in postmenopausal women.

Administration, Inhalation↗
PubMed2001

Underuse of inhaled steroid therapy in elderly patients with asthma.

STUDY OBJECTIVES: Despite their proven efficacy, inhaled steroids may be underused in the elderly asthmatic population. The objectives of this study were to determine if inhaled steroids are underused in the elderly asthmatic population, who are at a high risk for rehospitalization and mortality, and to identify certain risk factors that predict lower use of inhaled steroids in this group of patients. DESIGN: Population-based, retrospective, cohort study using linked data from hospital discharge and outpatient drug databases. PARTICIPANTS: All people > or = 65 years old in Ontario, Canada, who survived an acute exacerbation of asthma between April 1992 and March 1997. MEASUREMENTS AND RESULTS: Of the 6,254 patients, 2,495 patients (40%) did not receive inhaled steroid therapy within 90 days of discharge from their initial hospitalization for asthma. Patients > 80 years old were at a greater risk of not receiving inhaled steroid therapy, compared to those 65 to 70 years of age (adjusted odds ratio [OR], 1.23; 95% confidence interval [CI], 1.05 to 1.47). Patients with a Charlson comorbidity index of > or = 3 were also at an increased risk of not receiving inhaled steroid therapy, compared to those having no comorbidities (adjusted OR, 3.45; 95% CI, 1.56 to 7.69). Moreover, receipt of care from a primary-care physician was independently associated with an elevated risk of not receiving inhaled steroid therapy, compared to receipt of care from respirologists/allergists (adjusted OR, 1.35; 95% CI, 1.10 to 1.61). INTERPRETATION: Forty percent of Ontario patients > or = 65 years old who experienced a recent acute exacerbation of asthma did not receive inhaled steroid therapy near discharge from their initial hospitalization for asthma. Nonreceipt of inhaled steroid therapy was particularly prominent in the older patients with multiple comorbidities. Moreover, those who received care from primary-care physicians were also less likely to receive inhaled steroid therapy, compared to those who received care from specialists.

Acute Disease↗
PubMed1999

Salmeterol added to inhaled corticosteroid therapy is superior to doubling the dose of inhaled corticosteroids: a randomized clinical trial.

This randomized, double-blind, double-dummy, parallel group clinical trial compared the efficacy and safety of adding salmeterol xinafoate to concurrent inhaled beclomethasone dipropionate therapy with doubling the dose of beclomethasone dipropionate in patients experiencing symptoms on low-dose beclomethasone. Salmeterol added to low-dose beclomethasone was superior (p < or = 0.05) to doubling the dose of beclomethasone in improving peak expiratory flow (PEF) and forced expiratory volume in 1 sec (FEV1), and in reducing symptoms of asthma, sleep loss, nighttime awakenings, and use of albuterol. Both treatment regimens had comparable safety profiles. In asthma patients inadequately controlled despite the use of low-dose inhaled corticosteroids (i.e., less than 400 microg per day), the addition of salmeterol may be a more effective treatment option than doubling the dose of inhaled corticosteroids.

Administration, Inhalation↗
PubMed2002

Impaired recovery of hypothalamic-pituitary-adrenal axis function and hypoglycemic seizures after high-dose inhaled corticosteroid therapy in a toddler.

BACKGROUND: Corticosteroids are the treatment of choice for children with persistent reactive airway disease. In these patients, taper and discontinuation of systemic therapy is often facilitated by transition to high-dose inhaled corticosteroid treatment. OBJECTIVE: To report a case of impaired hypothalamic-pituitary-adrenal (HPA) axis recovery and adrenal crisis associated with prolonged high-dose inhaled therapy after long-term systemic corticosteroid treatment. METHODS: A 32-month-old child with severe airway obstruction and wheezing was treated with long-term daily systemic (intravenous and oral) corticosteroids followed by high-dose inhaled fluticasone (440 to 1,320 microg/day). This child presented in adrenal crisis, as evidenced by severe hypoglycemia and seizures, I day after receiving the influenza vaccine. After hydrocortisone replacement and a long taper of fluticasone, the child's adrenal function returned to normal. RESULTS: At the time of seizure, the serum glucose was 1 mg/dL. An electroencephalogram, computed tomographic scan, and magnetic resonance imaging of the brain were normal. Adrenal insufficiency was documented (morning serum cortisol, 0.6 microg/dL; after adrenocorticotrophic hormone stimulation, 8.4 microg/dL). Repeat evaluation 3 weeks after discontinuation of all corticosteroid therapy demonstrated normal HPA axis function. CONCLUSIONS: After treatment with long-term systemic steroids, high-dose inhaled corticosteroid therapy can impair recovery of the HPA axis and place patients at risk for adrenal crisis.

Administration, Inhalation↗
PubMed1999

Inhaled vasodilator therapy for treatment of acute lung injury.

In randomized controlled trials, inhaled nitric oxide failed to provide significant clinical benefit in patients with acute lung injury. Despite temporary improvement in oxygenation, inhaled nitric oxide neither improved survival, nor decreased length of mechanical ventilation. Thus, with the exception of severe hypoxaemia refractory to conventional therapy, inhaled nitric oxide is not indicated in patients with acute lung injury. Inhalation of prostacyclin and prostaglandin E1, respectively, has been associated with an improvement in oxygenation and a decrease in pulmonary artery pressure. Prospective randomized trials are warranted to assess the impact of inhaled prostaglandins on the outcome of patients with acute lung injury.

Journal Article↗
PubMed2002

Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids.

The addition of an inhaled long-acting beta2-agonist (LABA) to an inhaled corticosteroid (ICS) gives optimal control of asthma in most patients and two fixed combination inhalers (salmeterol/fluticasone and formoterol/budesonide) are increasingly used as a convenient controller in patients with persistent asthma. There is a strong scientific rationale for the combination of these two drug classes. ICS suppress the chronic inflammation of asthma and reduce airway hyperresponsiveness and this is achieved at low doses in most patients. LABA act on different aspects of the pathophysiology of asthma. In addition to their bronchodilator action, LABA also inhibit mast cell mediator release, plasma exudation and may reduce sensory nerve activation. Thus these two classes of drug address complementary aspects of the pathophysiology of asthma that neither drug class is able to achieve alone. There are several positive interactions between LABA and ICS. Corticosteroids increase the expression of beta2-receptors by increasing gene transcription. Experimentally this protects against the loss of beta2-receptors in response to long-term exposure to beta2-agonists. While this is unlikely to be important in bronchodilator responses to beta2-agonists, in view of the large beta-receptor reserve, it is probably important in preventing loss of beta-agonist effects on the nonbronchodilator actions of LABA discussed earlier. beta2-Agonists may potentiate the molecular mechanism of corticosteroid actions, with increased nuclear localization of glucocorticoid receptors and additive or sometimes synergistic suppression of inflammatory mediator release. Thus LABA and ICS may optimize each others beneficial actions in the airways, but the low systemic effects of these drugs do not result in any increase in adverse effects. Long-acting beta2-agonists corticosteroid inhaler therapy is therefore a logical advance and results in effective control of asthma in the majority of patients without significant adverse effects. This simplified approach to long-term asthma therapy has a strong scientific rationale.

Administration, Inhalation↗
PubMed1985

Inhaled corticosteroid therapy: a substitute for theophylline as well as prednisolone?

Topical corticosteroid treatment can be successfully achieved by inhaled therapy and can effectively provide a safe substitute for oral steroids. More than 8 million patient years of experience gained over a decade of use of inhaled steroids has shown them to be acceptable to patients and clinicians, with side effects confined to the upper airway. At daily doses of 200 to 1600 micrograms BDP or the equivalent, minor systemic activity may occasionally be demonstrated but no adverse systemic side effects have been reported. The topical anti-inflammatory treatment provided by inhaled steroids thus compares favorably with prednisolone and with other asthma therapy with respect to morbidity and mortality, suggesting that inhaled steroids combined with an inhaled beta-agonist is a safe and comprehensive treatment for chronic asthma. This parallel attack on inflammation and bronchoconstriction can be achieved with a morbidity that is much less than that of asthma and also likely to be less than that of the frequently used combination of theophylline and inhaled beta-agonist. Twice-daily regimens of inhaled steroids over a dose range of 200 to 1600 micrograms BDP or the equivalent should enable most patients with chronic asthma to receive effective therapy without recourse to potentially more toxic oral bronchodilator or steroid therapy.

Adrenal Cortex Hormones↗
PubMed2001

Impact of inhaled antiinflammatory therapy on hospitalization and emergency department visits for children with asthma.

OBJECTIVE: Although the efficacy of inhaled antiinflammatory therapy in improving symptoms and lung function in childhood asthma has been shown in clinical trials, the effectiveness of these medications in real-world practice settings in reducing acute health care use has not been well-evaluated. This study examined the effect of inhaled antiinflammatory therapy on hospitalizations and emergency department (ED) visits by children for asthma. DESIGN: Defined population cohort study over 1 year. Setting. Three managed care organizations (MCOs) in Seattle, Boston, and Chicago participating in the Pediatric Asthma Care-Patient Outcome Research and Treatment II trial. Participants. All 11 195 children, between 3 to 15 years old, with a diagnosis of asthma who were enrolled in the 3 MCOs between July 1996 and June 1997. OUTCOME MEASURES: We identified children with 1 or more asthma diagnoses using automated encounter data. Medication dispensings were identified from automated pharmacy data. Multivariate logistic regression analysis was used to calculate effects of inhaled antiinflammatory therapy on the adjusted relative risk (RR) for hospitalization and ED visits for asthma. RESULTS: Over 12 months, 217 (1.9%) of children had an asthma hospitalization, and 757 (6.8%) had an ED visit. After adjustment for age, gender, MCO, and reliever dispensing, compared with children who did not receive controllers, the adjusted RRs for an ED visit were: children with any (>/=1) dispensing of cromolyn, 0.4 (95% confidence interval [CI]: 0.3, 0.5); any inhaled corticosteroid (ICS), 0.5 (95% CI: 0.4, 0.6); any cromolyn or ICS combined (any controller), 0.4 (95% CI: 0.3, 0.5). For hospitalization, the adjusted RR for cromolyn was 0.6 (95% CI: 0.4, 0.9), for ICS 0.4 (95% CI: 0.3, 0.7), and for any controller 0.4 (95% CI: 0.3, 0.6). A significant protective effect for both events was seen among children with 1 to 5 and with >5 antiinflammatory dispensings. When the analysis was stratified by frequency of reliever dispensing, there was a significant protective effect for controllers on ED visits for children with 1 to 5 and with >5 reliever dispensings and on the risk of hospitalization for children with >5 reliever dispensings. CONCLUSIONS: Inhaled antiinflammatory therapy is associated with a significant protective effect on the risk for hospitalization and ED visits in children with asthma. Cromolyn and ICSs were associated with similar effects on risks.asthma drug therapy, inhaled antiinflammatory agents, health maintenance organizations, hospitalization, emergency department.

Administration, Inhalation↗
PubMedDate not supplied

Audit of inhaled asthma therapy.

The problems patients experience with inhaled asthma therapies are well documented. In an attempt to overcome these, the British Thoracic Society investigated the expansion of the respiratory nurse specialist's role to cover some of the more problematic areas of deficiency. In preparation for this expansion, the authors carried out an audit on 100 adults attending an asthma clinic. It established that more than half of the patients did not use their inhaler devices properly, and indicated which groups and skills required intervention from the respiratory nurse.

Administration, Inhalation↗
PubMed2006

The interaction of dietary antioxidant vitamins and oxidative stress on cough reflex in guinea-pigs after long term oxygen therapy.

Inhalation of high concentration of oxygen produces oxidative stress in men and experimental animals. Our previous experiments showed that the cough reflex is suppressed in guinea pigs after exposure to 100% O(2) for 60 hours. The aim of this study was to determine the effects of dietary antioxidant supplementation with vitamins C and E on hyperoxia-induced oxidative stress in airway and lung tissues directed on cough reflex. The experimental group (T-H, n=8) was pretreated with vitamins C (500 mg/kg) and E (300 mg/kg) for 4 weeks and subsequently exposed to 100% O(2) for 60 hours. Hyperoxic group (H, n=8) received saline instead of antioxidants and then inhaled 100% O(2) for 60 hours. Cough was induced by inhalation of citric acid aerosol in gradually increased concentration (0.05-1.6 M) at the end of antioxidant therapy and then at the end of exposure to 100% O(2). Cough was also induced by mechanical stimulation of laryngopharyngeal (LPh) and tracheobronchial (TBr) region in anaesthetized animals just 1 hour after the end of oxygen exposure. Our results showed a tendency to a decrease in citric acid-induced cough in hyperoxic animals and an increase in animals with antioxidant therapy after hyperoxia. Antioxidant therapy significantly unblocked hyperoxia-induced down-regulation of cough (P=0.004). Significant changes also were obtained from mechanically-induced TBr cough [2.5(1-4) vs. 1.0(1-2); P<0.01] between the experimental and hyperoxic (control) animals. In conclusion, our results indicate a protective effect of antioxidant supplementation on oxidant-mediated cough depression.

Animals↗
PubMed1999

Inhaled antimicrobial therapy.

Although antimicrobial therapy has been administered through the inhaled route for decades, it has always been controversial. There are relatively few accepted indications for this mode of administration. Well-controlled studies of aerosolized antibiotics in cystic fibrosis demonstrate that tobramycin on a cyclical basis may reduce sputum volume, bacterial counts, and improve pulmonary function. Preliminary data indicate that inhaled antibiotic therapy of ventilator-associated tracheobronchitis may reduce sputum volume, but the clinical significance of this finding remains to be determined. Inhaled pentamidine is used for prophylaxis of Pneumocystis carinii in patients with human immunodeficiency virus infection who are intolerant of oral prophylactic agents. Ribavirin has been used for 30 years to treat respiratory syncytial virus. The role, if any, of inhaled antifungal therapy with amphotericin B remains undetermined.

AIDS-Related Opportunistic Infections↗
PubMed2004

How to achieve good compliance with inhaled asthma therapy.

Inability to use inhaler devices correctly is a major source of non-compliance in patients with asthma. The problem of coordinating dose release with inspiration seen with pressurised metered dose inhalers (pMDIs) is overcome by dry powder inhalers (DPIs), since they use inspiratory flow energy to carry the drug dose to the respiratory tract. The first DPIs were not popular because they were single dose devices and inconvenient to use. The introduction of multiple dose DPIs improved the image of the dry powder systems in the eyes of both the clinician and the patient. The continued development of DPIs has led to inhaler devices which include dose counters, are easy to use, are refillable and provide feedback to the patient on a correct inhalation. Criteria that may improve patient compliance with an inhaler include: correct use of the device by most patients; ease and convenience of device use; dose release even at low inspiratory flow rates; feedback of drug release which could instill confidence that the dose has been inhaled; cartridge refills and overall confidence in the device. The Novolizer has all the desirable features listed above and is expected to improve compliance if prescribed for the large number of patients who cannot use the conventional pMDI or less efficient DPSs.

Administration, Inhalation↗