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

COPD Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01466712
• Other study ID #: S53020
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: November 4, 2011
• Last updated: July 29, 2013
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2013
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Disease, Chronic Obstructive
• Small Airway Disease

Intervention

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.
• tiotropium + placebo
Tiotropium 18 µg/dose once daily (handihaler device) + placebo (Pressurised inhaler): 2 puffs bid, for one month.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Flanders

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	Before run-in	No
Primary	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).	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).	at randomization	No
Primary	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).	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).	at the end of each treatment period of 4 weeks	No
Secondary	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	No