Clinical trial NCT01466712: Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COPD
Emphysema
Small Airway Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2011-11-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Before run-in
measure: 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).
timeFrame: at randomization
measure: 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).
timeFrame: at the end of each treatment period of 4 weeks
Secondary outcomes:
measure: Relate the abnormalities found in tests of small airway function with the findings of probe-based confocal laser endomicroscopy
timeFrame: Before run-in at the end of each treatment period of 4 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Flanders
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Marc Decramer, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: