Status:
COMPLETED
Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
Detailed Description
The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00862264
Start Date
August 1 2004
End Date
September 1 2005
Last Update
March 30 2017
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