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A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

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ClinicalTrials.gov Identifier: NCT00862394
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE March 13, 2009
First Posted Date  ICMJE March 16, 2009
Last Update Posted Date April 13, 2018
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2009)
Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic [ Time Frame: 3 month period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Pre-dose FEV1 [ Time Frame: every month ]
  • Post-dose FEV1 AUC 0-8 h [ Time Frame: 3 month period ]
  • FVC and FEF 25-75% [ Time Frame: every month ]
  • PEF [ Time Frame: every day ]
  • Morning and evening asthma clinical symptoms scores [ Time Frame: every day ]
  • Moderate and severe exacerbations [ Time Frame: every month ]
  • Rescue medication [ Time Frame: every day ]
  • Sputum [ Time Frame: 3 month period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2009)
  • Pre-dose FEV1 [ Time Frame: at each clinic visit ]
  • Post-dose FEV1 AUC 0-8 h [ Time Frame: at each clinic visit ]
  • FVC and FEF 25-75% [ Time Frame: at each clinic visit ]
  • PEF [ Time Frame: at each clinic visit ]
  • Morning and evening asthma clinical symptoms scores [ Time Frame: at each clinic visit ]
  • Moderate and severe exacerbations [ Time Frame: at each clinic visit ]
  • Rescue medication [ Time Frame: at each clinic visit ]
  • Sputum [ Time Frame: at each clinic visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma
Official Title  ICMJE A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids
Brief Summary To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: BDP/Formoterol Next DPI
    BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
  • Drug: Foster
    BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
  • Drug: BDP/Formoterol Next DPI
    BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
  • Drug: Foster
    BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
Study Arms  ICMJE
  • Experimental: 1
    CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg
    Intervention: Drug: BDP/Formoterol Next DPI
  • Active Comparator: 2
    CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg
    Intervention: Drug: Foster
  • Experimental: 3
    CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg
    Intervention: Drug: BDP/Formoterol Next DPI
  • Active Comparator: 4
    CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg
    Intervention: Drug: Foster
Publications * Not Provided

*   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: August 24, 2012)
783
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2009)
831
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent
  • Outpatients of both sexes, aged > 12 years
  • Moderate to severe symptomatic asthma
  • Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values
  • Reversibility test
  • "Partly controlled" asthma (GINA revised 2006)
  • Patients free of long-acting beta2-agonists (LABAs) treatment
  • Under inhaled corticosteroids (ICS) treatment
  • A minimum inspiratory flow ≥ 40 L/min 10.
  • Non-smokers or ex smokers
  • Asthma Control Questionnaire ACQ score ≥ 1.5

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
  • Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
  • History of near fatal asthma
  • Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
  • Diagnosis COPD
  • History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
  • Diagnosis of restrictive lung disease
  • Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
  • Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
  • Allergy to any component of the study treatments
  • Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
  • Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
  • Patients with abnormal QTc
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, 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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862394
Other Study ID Numbers  ICMJE CCD-0705-PR-0027
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 Not Provided
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date April 2018

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