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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CHF 1535 pMDI

    BDP pMDI

    Arm Description

    CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose

    Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose

    Outcomes

    Primary Outcome Measures

    Pre-dose morning PEF

    Secondary Outcome Measures

    Pre-dose FEV1 - Other spirometric parameters -
    Percentage of night and/or days free of clinical symptoms
    Morning and evening asthma clinical symptom scores
    Use of rescue short-acting b2-agonists
    Asthma exacerbations
    Safety and Tolerability

    Full Information

    First Posted
    February 25, 2009
    Last Updated
    March 28, 2017
    Sponsor
    Chiesi Farmaceutici S.p.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00862264
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chiesi Farmaceutici S.p.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    286 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CHF 1535 pMDI
    Arm Type
    Experimental
    Arm Description
    CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose
    Arm Title
    BDP pMDI
    Arm Type
    Active Comparator
    Arm Description
    Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose
    Intervention Type
    Drug
    Intervention Name(s)
    Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
    Intervention Description
    Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
    Primary Outcome Measure Information:
    Title
    Pre-dose morning PEF
    Time Frame
    At the end of treatment after 3 month of treatment
    Secondary Outcome Measure Information:
    Title
    Pre-dose FEV1 - Other spirometric parameters -
    Time Frame
    Every 6 weeks
    Title
    Percentage of night and/or days free of clinical symptoms
    Time Frame
    End of treatment after 3 month of treatment
    Title
    Morning and evening asthma clinical symptom scores
    Time Frame
    End of treatment after 3 month of treatment
    Title
    Use of rescue short-acting b2-agonists
    Time Frame
    End of treatment after 3 month of treatment
    Title
    Asthma exacerbations
    Time Frame
    Every 6 weeks
    Title
    Safety and Tolerability
    Time Frame
    Every 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Françoise Bonnet Gonod
    Organizational Affiliation
    Chiesi Farmaceutici
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://www.clinicaltrialsregister.eu/ctr-search/search?query=2004-000718-37
    Description
    Study Record on EU Clinical Trials Register including results

    Learn more about this trial

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

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