Clinical trial NCT00862264: Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2009-03-16
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.

Eligibility 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

Primary outcomes:
measure: Pre-dose morning PEF
timeFrame: At the end of treatment after 3 month of treatment
Secondary outcomes:
measure: Pre-dose FEV1 - Other spirometric parameters -
timeFrame: Every 6 weeks
measure: Percentage of night and/or days free of clinical symptoms
timeFrame: End of treatment after 3 month of treatment
measure: Morning and evening asthma clinical symptom scores
timeFrame: End of treatment after 3 month of treatment
measure: Use of rescue short-acting b2-agonists
timeFrame: End of treatment after 3 month of treatment
measure: Asthma exacerbations
timeFrame: Every 6 weeks
measure: Safety and Tolerability
timeFrame: Every 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chiesi Farmaceutici
name: Françoise Bonnet Gonod
role: STUDY_DIRECTOR
References: