Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma

October 30, 2024 updated by: Chiesi Farmaceutici S.p.A.

A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma

Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.

Study Type

Interventional

Enrollment (Actual)

824

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)
  • FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)

  • Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:

    750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)

  • Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 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.
  • Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
  • Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females.
  • Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability > 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: beclometasone /formoterol
beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI
Drug: beclomethasone/formoterol (100/6µg) pMDI
Two puffs b.i.d
Active Comparator: Beclomethasone
Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.
Drug: Beclometasone dipropionate 250 µg/unit dose pMDI
2 inhalations bid
Other Names:
  • BecotideTM
Active Comparator: Formoterol powder 12 µg/unit dose
Formoterol powder 12 µg/unit dose (Foradil™)
Drug: Formoterol powder 12 µg/unit dose
2 inhalations bid
Other Names:
  • Foradil™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pre-dose morning PEF
Time Frame: End of treatment
End of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pre-dose FEV1
Time Frame: At clinic visits
At clinic visits
Other spirometric parameters
Time Frame: At clinic visits
At clinic visits
Morning and evening asthma clinical symptom scores
Time Frame: End of treatment
End of treatment
Percentage of night and/or days free of clinical symptoms
Time Frame: End of treatment
End of treatment
Use of rescue short-acting b2-agonists
Time Frame: End of treatment
End of treatment
Asthma exacerbations
Time Frame: end of treatment
end of treatment
safety and tolerability
Time Frame: end of treatment
end of treatment

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: Francoise 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.

General Publications

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

February 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimated)

May 21, 2007

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM/PR/033011/003/03

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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