Flunisolide in the Treatment of Mild to Moderate Asthma
Flunisolide in the Treatment of Mild to Moderate Asthma
Objective: To evaluate the efficacy and tolerability of flunisolide given once-daily in patients with persistent asthma versus other inhaled corticosteroids given in standard multidose regimens.
Patients and Methods: A total of 515 patients aged 16 to 75 years with mild to moderate asthma stabilised on multidose regimens of various inhaled corticosteroids were enrolled in an 8-week, open-label, multicentre, randomised, parallel-group study. Patients were randomised in a 4:1 ratio to receive either once-daily flunisolide (1000µg at 6pm increased if necessary up to 2000µg; n = 416) administered via AeroChamber or their previous corticosteroid regimens (triamcinolone, beclomethasone or fluticasone propionate; n = 99), which were continued on a 2- to 4-times daily basis at the previously established dosages. The transfer to once-daily flunisolide from the previous regimen was made directly without a run-in period.
Results: The treatment 'success rate' [percentage of patients whose forced expiratory volume in 1 second (FEV1) values at the study end-point were at least 90% of baseline values] was 85.7% in both treatment groups. Other efficacy parameters, including percentage predicted FEV1, morning and evening peak expiratory flow rate (PEFR) values, asthma symptom scores, salbutamol (albuterol) usage, nocturnal awakenings, quality-of-life scores and global rating of change were also similar in the two groups. The incidence of drug-related adverse events such as headache, increased cough, pharyngitis, nausea and oral candidiasis were low in both groups (≤1.7% with flunisolide), and there were no notable changes in vital signs or physical examination variables in either group. The majority of patients expressed a preference for the once-daily flunisolide dosage regimen.
Conclusions: Once-daily flunisolide provided asthma therapy that was at least as effective and as well tolerated as the patients' previous inhaled corticosteroid medication, indicating that individuals with mild to moderate asthma can be directly transferred to once-daily flunisolide therapy without compromising efficacy and tolerability.
Since their introduction into clinical practice more than two decades ago, inhaled corticosteroids have become first-line medications for the prophylactic treatment of bronchial asthma. Not only have these agents proved effective in reducing the symptoms of asthma, decreasing bronchial hyperreactivity and reducing acute exacerbations, but they also have a wide tolerability margin, especially in comparison with systemic corticosteroids.
However, despite their proven efficacy in short-term clinical trials, morbidity and mortality levels among patients with asthma remain high. The reasons for this are not firmly established but may be due, in part, to noncompliance by patients with the treatment. As many as 40%of asthma patients may not adhere to their prescribed treatment, and some continue to use inhaled corticosteroids on an 'as needed' rather than a regular basis. This situation may result from a lack of understanding of the rationale for preventive treatment, complicated/difficult-to-use dosage regimens, problems in using inhaler devices, and poor doctor-patient communication. Patient attitude, such as complacency, forgetfulness, poor quality of life, and cultural factors may also contribute to poor compliance.
Currently, most inhaled corticosteroids available in the USAare administered in multidose regimens ranging from 2 to 4 times daily. In an effort to improve the level of compliance with inhaled corticosteroid therapy, recent studies have evaluated whether a reduction in dose frequency to once daily, which would be more convenient for patients, is associated with similar efficacy and tolerability as multidose administration. A recent study with flunisolide delivered via a metered-dose inhaler (MDI) has shown that switching patients from a twice-daily to a once-daily regimen was associated with equivalent asthma control and was well tolerated.
We therefore investigated whether patients with mild to moderate asthma who were stabilised on various multidose regimens of other inhaled corticosteroids could be directly transferred to once-daily flunisolide without compromising efficacy or tolerability. In this study, flunisolide was administered via the AeroChamber spacer device to reduce orophayngeal deposition of the corticosteroid and compensate for poor inhaler technique.
Objective: To evaluate the efficacy and tolerability of flunisolide given once-daily in patients with persistent asthma versus other inhaled corticosteroids given in standard multidose regimens.
Patients and Methods: A total of 515 patients aged 16 to 75 years with mild to moderate asthma stabilised on multidose regimens of various inhaled corticosteroids were enrolled in an 8-week, open-label, multicentre, randomised, parallel-group study. Patients were randomised in a 4:1 ratio to receive either once-daily flunisolide (1000µg at 6pm increased if necessary up to 2000µg; n = 416) administered via AeroChamber or their previous corticosteroid regimens (triamcinolone, beclomethasone or fluticasone propionate; n = 99), which were continued on a 2- to 4-times daily basis at the previously established dosages. The transfer to once-daily flunisolide from the previous regimen was made directly without a run-in period.
Results: The treatment 'success rate' [percentage of patients whose forced expiratory volume in 1 second (FEV1) values at the study end-point were at least 90% of baseline values] was 85.7% in both treatment groups. Other efficacy parameters, including percentage predicted FEV1, morning and evening peak expiratory flow rate (PEFR) values, asthma symptom scores, salbutamol (albuterol) usage, nocturnal awakenings, quality-of-life scores and global rating of change were also similar in the two groups. The incidence of drug-related adverse events such as headache, increased cough, pharyngitis, nausea and oral candidiasis were low in both groups (≤1.7% with flunisolide), and there were no notable changes in vital signs or physical examination variables in either group. The majority of patients expressed a preference for the once-daily flunisolide dosage regimen.
Conclusions: Once-daily flunisolide provided asthma therapy that was at least as effective and as well tolerated as the patients' previous inhaled corticosteroid medication, indicating that individuals with mild to moderate asthma can be directly transferred to once-daily flunisolide therapy without compromising efficacy and tolerability.
Since their introduction into clinical practice more than two decades ago, inhaled corticosteroids have become first-line medications for the prophylactic treatment of bronchial asthma. Not only have these agents proved effective in reducing the symptoms of asthma, decreasing bronchial hyperreactivity and reducing acute exacerbations, but they also have a wide tolerability margin, especially in comparison with systemic corticosteroids.
However, despite their proven efficacy in short-term clinical trials, morbidity and mortality levels among patients with asthma remain high. The reasons for this are not firmly established but may be due, in part, to noncompliance by patients with the treatment. As many as 40%of asthma patients may not adhere to their prescribed treatment, and some continue to use inhaled corticosteroids on an 'as needed' rather than a regular basis. This situation may result from a lack of understanding of the rationale for preventive treatment, complicated/difficult-to-use dosage regimens, problems in using inhaler devices, and poor doctor-patient communication. Patient attitude, such as complacency, forgetfulness, poor quality of life, and cultural factors may also contribute to poor compliance.
Currently, most inhaled corticosteroids available in the USAare administered in multidose regimens ranging from 2 to 4 times daily. In an effort to improve the level of compliance with inhaled corticosteroid therapy, recent studies have evaluated whether a reduction in dose frequency to once daily, which would be more convenient for patients, is associated with similar efficacy and tolerability as multidose administration. A recent study with flunisolide delivered via a metered-dose inhaler (MDI) has shown that switching patients from a twice-daily to a once-daily regimen was associated with equivalent asthma control and was well tolerated.
We therefore investigated whether patients with mild to moderate asthma who were stabilised on various multidose regimens of other inhaled corticosteroids could be directly transferred to once-daily flunisolide without compromising efficacy or tolerability. In this study, flunisolide was administered via the AeroChamber spacer device to reduce orophayngeal deposition of the corticosteroid and compensate for poor inhaler technique.