Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

• Registration Number: NCT00862264
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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.

Study Timeline

• Study Start: 2004-08
• Study Completion: 2005-09
• Study First Submitted: 2009-02-25
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF 1535 pMDI	Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI	CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose
BDP pMDI	Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI	Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose

Primary Outcome Measures

Name	Time	Method
Pre-dose morning PEF	At the end of treatment after 3 month of treatment

Secondary Outcome Measures

Name	Time	Method
Pre-dose FEV1 - Other spirometric parameters -	Every 6 weeks
Use of rescue short-acting b2-agonists	End of treatment after 3 month of treatment
Percentage of night and/or days free of clinical symptoms	End of treatment after 3 month of treatment
Asthma exacerbations	Every 6 weeks
Safety and Tolerability	Every 6 weeks
Morning and evening asthma clinical symptom scores	End of treatment after 3 month of treatment