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

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ClinicalTrials.gov Identifier: NCT00476268
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE May 18, 2007
First Posted Date  ICMJE May 21, 2007
Last Update Posted Date July 31, 2020
Study Start Date  ICMJE February 2004
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2007)
Pre-dose morning PEF [ Time Frame: End of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
  • Pre-dose FEV1 [ Time Frame: At clinic visits ]
  • Other spirometric parameters [ Time Frame: At clinic visits ]
  • Morning and evening asthma clinical symptom scores [ Time Frame: End of treatment ]
  • Percentage of night and/or days free of clinical symptoms [ Time Frame: End of treatment ]
  • Use of rescue short-acting b2-agonists [ Time Frame: End of treatment ]
  • Asthma exacerbations [ Time Frame: end of treatment ]
  • safety and tolerability [ Time Frame: end of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2007)
  • Pre-dose FEV1 [ Time Frame: At clinic visits ]
  • Other spirometric parameters [ Time Frame: At clinic visits ]
  • Morning and evening asthma clinical symptom scores [ Time Frame: End of treatment ]
  • Percentage of night and/or days free of clinical symptoms [ Time Frame: End of treatment ]
  • Use of rescue short-acting b2-agonists [ Time Frame: End of treatment ]
  • Asthma exacerbations
  • safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
Official Title  ICMJE 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
Brief Summary Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: beclomethasone/formoterol (100/6µg) pMDI
    Two puffs b.i.d
  • Drug: Beclometasone dipropionate 250 µg/unit dose pMDI
    2 inhalations bid
    Other Name: BecotideTM
  • Drug: Formoterol powder 12 µg/unit dose
    2 inhalations bid
    Other Name: Foradil™
Study Arms  ICMJE
  • Experimental: beclometasone /formoterol
    beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI
    Intervention: Drug: beclomethasone/formoterol (100/6µg) pMDI
  • Active Comparator: Beclomethasone
    Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.
    Intervention: Drug: Beclometasone dipropionate 250 µg/unit dose pMDI
  • Active Comparator: Formoterol powder 12 µg/unit dose
    Formoterol powder 12 µg/unit dose (Foradil™)
    Intervention: Drug: Formoterol powder 12 µg/unit dose
Publications * Huchon G, Magnussen H, Chuchalin A, Dymek L, Gonod FB, Bousquet J. Lung function and asthma control with beclomethasone and formoterol in a single inhaler. Respir Med. 2009 Jan;103(1):41-9. doi: 10.1016/j.rmed.2008.09.002. Epub 2008 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2012)
824
Original Enrollment  ICMJE
 (submitted: May 18, 2007)
600
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00476268
Other Study ID Numbers  ICMJE DM/PR/033011/003/03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Francoise Bonnet-Gonod Chiesi Farmaceutici
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP