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Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function

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ClinicalTrials.gov Identifier: NCT01466712
Recruitment Status : Unknown
Verified July 2013 by Marc Decramer, KU Leuven.
Recruitment status was:  Enrolling by invitation
First Posted : November 8, 2011
Last Update Posted : July 30, 2013
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Marc Decramer, KU Leuven

Tracking Information
First Submitted Date  ICMJE November 4, 2011
First Posted Date  ICMJE November 8, 2011
Last Update Posted Date July 30, 2013
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
  • Physiologically measured small airway function based on MBW variables (Scond and Sacin) and lung functional variables (N2-washout, studying the plateau of phase III and closing volume). [ Time Frame: Before run-in ]
    After a run-in period of 4 weeks in which all patients will receive Tiotropium 18 pig per day as treatment for their disease, they will be randomized in two groups: one group receiving Tiotropium + placebo and another group receiving Tiotropium + Inuvair 2 puffs bid, for one month. After this treatment period, there will be a wash-out period of 4 weeks (with tiotropium as run-in).
  • Physiologically measured small airway function based on MBW variables (Scond and Sacin) and lung functional variables (N2-washout, studying the plateau of phase III and closing volume). [ Time Frame: at randomization ]
    After a run-in period of 4 weeks in which all patients will receive Tiotropium 18 pig per day as treatment for their disease, they will be randomized in two groups: one group receiving Tiotropium + placebo and another group receiving Tiotropium + Inuvair 2 puffs bid, for one month. After this treatment period, there will be a wash-out period of 4 weeks (with tiotropium as run-in).
  • Physiologically measured small airway function based on MBW variables (Scond and Sacin) and lung functional variables (N2-washout, studying the plateau of phase III and closing volume). [ Time Frame: at the end of each treatment period of 4 weeks ]
    After a run-in period of 4 weeks in which all patients will receive Tiotropium 18 pig per day as treatment for their disease, they will be randomized in two groups: one group receiving Tiotropium + placebo and another group receiving Tiotropium + Inuvair 2 puffs bid, for one month. After this treatment period, there will be a wash-out period of 4 weeks (with tiotropium as run-in).
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2011)
Physiologically measured small airway function based on MBW variables (Scond and Sacin) and lugn functional variables (N2-washout, studying the plateau of phase III and closing volume). [ Time Frame: Before run-in, at randomization and at the end of each treatment period of 4 weeks ]
After a run-in period of 4 weeks in which all patients will receive Tiotropium 18 pig per day as treatment for their disease, they will be randomized in two groups: one group receiving Tiotropium + placebo and another group receiving Tiotropium + Inuvair 2 puffs bid, for one month. After this treatment period, there will be a wash-out period of 4 weeks (with tiotropium as run-in).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2011)
Relate the abnormalities found in tests of small airway function with the findings of probe-based confocal laser endomicroscopy [ Time Frame: Before run-in at the end of each treatment period of 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function
Official Title  ICMJE Randomized Double-blind Placebo-controlled Crossover Study to Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function in COPD Patients.
Brief Summary Inuvair® is a novel fixed combination product used in the treatment of asthma and under clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is able to target the whole bronchial tree, including the small airways and hence, is expected to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its action on the small airways is not directly demonstrated thus far. By way of contrast, dear evidence is present that treatment with bronchodilators alone does not beneficially alter small airway function. The study hypothesis states that the effects of inhaled corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • COPD
  • Emphysema
  • Small Airway Disease
Intervention  ICMJE
  • Drug: Tiotropium + formoterol/beclometasone
    Tiotropium 18 µg/dose once daily (handihaler device) + formoterol, fumarate 6µg + beclometasone, dipropionate 100µg / dose (Pressurised inhaler): 2 puffs bid, for one month.
    Other Name: Inuvair (B10356)
  • Drug: tiotropium + placebo
    Tiotropium 18 µg/dose once daily (handihaler device) + placebo (Pressurised inhaler): 2 puffs bid, for one month.
    Other Name: drug code number B10356
Study Arms  ICMJE
  • Experimental: Tiotropium+formoterol/beclomethasone
    run-in of 4 weeks with thiotropium cross-over after first treatment period of 4 weeks
    Intervention: Drug: Tiotropium + formoterol/beclometasone
  • Sham Comparator: tiotropium+placebo
    cross-over cfr arm1
    Intervention: Drug: tiotropium + placebo
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 4, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical diagnosis COPD according to last updated GOLD guidelines (post- bronchodilator FEV/FVC below 0,70, FEV1 <80% predicted)
  • ex-smokers (ie 1 year from the last cigarette) with at least 10 pack years.
  • GOLD stage II and III (FEV1 > 30% predicted)
  • by preference naïve to inhaled corticosteroids; in those taking inhaled corticosteroids this medication will be stopped 1 month prior to enrollment in the study
  • Patients must have proven small airways dysfunction on routine spirometry as reflected by a drop in FEF25-75 and FEF75 of at least 50%. Moreover, patients must have proven small airways dysfunction on MBW as reflected by Sacin >0,120 that is considered abnormal.

Exclusion Criteria:

  • Current smoking
  • Active COPD exacerbation
  • gold stage I and IV
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01466712
Other Study ID Numbers  ICMJE S53020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Decramer, KU Leuven
Study Sponsor  ICMJE KU Leuven
Collaborators  ICMJE Chiesi Farmaceutici S.p.A.
Investigators  ICMJE
Principal Investigator: Marc Decramer, Md, PhD Universitaire Ziekenhuizen Leuven
PRS Account KU Leuven
Verification Date July 2013

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