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

March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.

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

Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHF 1535 pMDI
CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose
Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Active Comparator: BDP pMDI
Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose
Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pre-dose morning PEF
Time Frame: At the end of treatment after 3 month of treatment
At the end of treatment after 3 month of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Study Director: Françoise Bonnet Gonod, Chiesi Farmaceutici

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (Estimate)

March 16, 2009

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA/PR/033011/005/04
  • 2004-000718-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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