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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00476268
First received: May 18, 2007
Last updated: April 2, 2012
Last verified: April 2012

May 18, 2007
April 2, 2012
February 2004
January 2005   (final data collection date for primary outcome measure)
Pre-dose morning PEF [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Pre-dose morning PEF [ Time Frame: End of treatment ]
Complete list of historical versions of study NCT00476268 on ClinicalTrials.gov Archive Site
  • Pre-dose FEV1 [ Time Frame: At clinic visits ] [ Designated as safety issue: No ]
  • Other spirometric parameters [ Time Frame: At clinic visits ] [ Designated as safety issue: No ]
  • Morning and evening asthma clinical symptom scores [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Percentage of night and/or days free of clinical symptoms [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Use of rescue short-acting b2-agonists [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Asthma exacerbations [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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™
  • 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
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. Epub 2008 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
824
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00476268
DM/PR/033011/003/03
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Study Director: Francoise Bonnet-Gonod Chiesi Farmaceutici
Chiesi Farmaceutici S.p.A.
April 2012

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