As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma
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|ClinicalTrials.gov Identifier: NCT00382889|
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : October 2, 2006
The aim of this study is to reveal that inhaled corticosteroid therapy combined with a short-acting beta2- agonist given on a symptom driven basis is as effective as traditional asthma therapy.
Thus, three advantages will be achieved:
- better compliance with treatment since patients will most likely have to administer the treatment less frequently,
- maximum pharmacological effect with the least amount of drug and
- less economic burden on health care providers.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: beclomethasone/salbutamol combination Drug: beclomethasone Drug: salbutamol||Phase 3|
Asthma is widely recognised as a chronic inflammatory disorder of the airways. The 1997 American National Heart Lung and Blood Institute (NHLBI) Guidelines states that a firm scientific basis exists to indicate that asthma results from complex interactions among inflammatory cells, mediators and the cells and tissues resident in the airways.
Despite the existence of effective therapy people still die from asthma. It is pertinent to state that the clinical effect of a drug is not only dependent on the specific action of the drug, but also on the patient’s way of using it. Therefore, compliance is an important factor especially for chronic disorders such as asthma. Indeed, non compliance with asthma therapy is a serious problem. It has been reported that drug side effects, lifestyle, social and economic factors, method of drug delivery and dosing are factors that contribute to poor compliance. The consequences of poor compliance lead to increased morbidity due to increased symptoms and asthma exacerbation.
The NHLBI Guidelines recommend daily treatment for patients with mild persistent asthma with inhaled glucocorticoids (200-500mcg/die) and short-acting bronchodilators as needed but no more than 3-4 times a day.
Comparisons: beclomethasone dipropionate 250 mg combined with salbutamol 100 mg “as needed”, vs salbutamol 100 mg alone “as needed”, vs beclomethasone 250 mg twice a day plus salbutamol 100 mg “as needed” and vs beclomethasone dipropionate 250 mg combined with salbutamol 100 mg twice a day plus salbutamol 100 mg “as needed”, in the treatment of patients with mild persistent asthma.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multinational, Double Blind, Randomised, Parallel Group Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate 250 mg Combined With Salbutamol 100 mg in the Treatment of Patients With Mild Persistent Asthma.|
|Study Start Date :||August 2002|
|Study Completion Date :||September 2004|
- The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
- Number of exacerbations
- Time to first severe exacerbation
- Improvement of asthma symptoms (symptom scores)
- Need for short acting b2 agonists
- Variation of respiratory parameters (FEV1, PEF, FVC, FEV1/FVC, FEF25-75) immediately before and 30 min after a test with a short-acting b2 agonist
- evening PEF
- Diurnal variability of PEF
- Nocturnal asthma (nocturnal awakening because of asthma)
- Nights and days without asthma symptoms (score 0)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382889
|Principal Investigator:||Leonardo M Fabbri, MD||Clinica di Malattie dell’Apparato Respiratorio, Dipartimento di Oncologia, Ematologia e Pneumologia, Università di Modena e Reggio Emilia, Italy|