As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma
Study Identifier:
MC/PR/1401/001/01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: beclomethasone/salbutamol combination
- Drug: beclomethasone
- Drug: salbutamol
Date
Aug 2002 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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 Criteria
- 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;
Healthy Volunteers
No
Protocol 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, three advantages will be achieved:
1. better compliance with treatment since patients will most likely have to administer the treatment less frequently,
2. maximum pharmacological effect with the least amount of drug and
3. less economic burden on health care providers.
Study Locations
Location
Status
Location
Ambulance for pediatrics and Pneumology
Vienna, Austria
Status
N/A
Location
Pulmologisches Zentrum Der Stadt Wien
Vienna, Austria
Status
N/A
Location
Dip. di Pneumologia - Osp. Tommaselli
Catania, Italy
Status
N/A
Location
Nuove Cliniche Arcispedale S.Anna
Ferrara, Italy
Status
N/A
Location
DIMI - Dip. Medicina Interna - Univ. di Genova - clinica di malattie apparato respiratorio e allergologico
Genova, Italy
Status
N/A
Location
Dipartimento di scienze mediche oncologiche e radiologiche - sez. malattie apparato respiratorio
Modena, Italy
Status
N/A
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