Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma
A 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma
2 other identifiers
interventional
286
0 countries
N/A
Brief Summary
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Aug 2004
Shorter than P25 for phase_3 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 25, 2009
CompletedFirst Posted
Study publicly available on registry
March 16, 2009
CompletedMarch 30, 2017
March 1, 2017
February 25, 2009
March 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pre-dose morning PEF
At the end of treatment after 3 month of treatment
Secondary Outcomes (6)
Pre-dose FEV1 - Other spirometric parameters -
Every 6 weeks
Percentage of night and/or days free of clinical symptoms
End of treatment after 3 month of treatment
Morning and evening asthma clinical symptom scores
End of treatment after 3 month of treatment
Use of rescue short-acting b2-agonists
End of treatment after 3 month of treatment
Asthma exacerbations
Every 6 weeks
- +1 more secondary outcomes
Study Arms (2)
CHF 1535 pMDI
EXPERIMENTALCHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose
BDP pMDI
ACTIVE COMPARATORBeclomethasone dipropionate-CFC pMDI, 250 µg/unit dose
Interventions
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
- FEV1 \> or = 60% and \< or = 85% of predicted normal values
- A documented positive response to the reversibility test
You may not qualify if:
- Pregnant or lactating females or women of childbearing potential without any efficient contraception
- Heavy smokers defined as smoking for \> 10 pack years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Françoise Bonnet Gonod
Chiesi Farmaceutici
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2009
First Posted
March 16, 2009
Study Start
August 1, 2004
Study Completion
September 1, 2005
Last Updated
March 30, 2017
Record last verified: 2017-03