Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma
Study Identifier:
RA/PR/033011/005/04
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Date
Aug 2004 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 70 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
- FEV1 \> or = 60% and \< or = 85% of predicted normal values
- Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion
- A documented positive response to the reversibility test
Exclusion Criteria
- Pregnant or lactating females or women of childbearing potential without any efficient contraception
- Heavy smokers defined as smoking for \> 10 pack years
- Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids)
- Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer
- Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
- Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability \> or = 30% during 2 consecutive days, SABA use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
Healthy Volunteers
No
Protocol Summary
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
Study Locations
No locations found.