Status:
COMPLETED
As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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,...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Clinical diagnosis of mild persistent asthma as defined by NHLBI/WHO 97; for at least 6 months;
- FEV1 ³ 75% of predicted normal value;
- Positive response to the reversibility test to b2 agonist, defined as an increase \> 12% in the FEV1 measured 30 minutes following 2 puffs (2x100mg) of inhaled Salbutamol spray, or positive methacholine challenge (PC20\<8mg/ml or PD20\<1 mg) within the previous 6 months;
- Stable asthma. Asthma is defined stable if none of the following occurred during the last 14 days of the run-in period: diurnal variation of more than 20% in PEF on 2 consecutive days; use of four or more inhalations of b2 agonist per day on two consecutive days; need the use of oral corticosteroids;
Exclusion
- COPD as defined by the ERS - Consensus Statement;
- Patients with more than 10 packs/year of cigarettes history and current smokers;
- History of near fatal asthma and/or admission in intensive care unit because of asthma;
- One severe exacerbation during the run-in period;
- Three or more courses of oral corticosteroids or hospitalisation for asthma during the previous 1 year;
- Patients treated with more than 500 mcg/day of beclomethasone or equivalent for more than 6 months in the previous last year;
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00382889
Start Date
August 1 2002
End Date
September 1 2004
Last Update
August 3 2020
Active Locations (25)
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1
Ambulance for pediatrics and Pneumology
Vienna, Austria
2
Pulmologisches Zentrum Der Stadt Wien
Vienna, Austria
3
Dip. di Pneumologia - Osp. Tommaselli
Catania, Italy
4
Nuove Cliniche Arcispedale S.Anna
Ferrara, Italy