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

Phase 4

• Conditions: COPD; Emphysema; Small Airway Disease
• Interventions: Drug: tiotropium + placebo; Drug: Tiotropium + formoterol/beclometasone

• Registration Number: NCT01466712
• Lead Sponsor: KU Leuven

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 available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tiotropium+placebo	tiotropium + placebo	cross-over cfr arm1
Tiotropium+formoterol/beclomethasone	Tiotropium + formoterol/beclometasone	run-in of 4 weeks with thiotropium cross-over after first treatment period of 4 weeks

Primary Outcome Measures

Name	Time	Method
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).	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).

Secondary Outcome Measures

Name	Time	Method
Relate the abnormalities found in tests of small airway function with the findings of probe-based confocal laser endomicroscopy	Before run-in at the end of each treatment period of 4 weeks

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Flanders, Belgium