Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function - Full Text View

Purpose

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.

Condition	Intervention	Phase
COPD Emphysema Small Airway Disease	Drug: Tiotropium + formoterol/beclometasone Drug: tiotropium + placebo	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

Drug Information available for: Beclomethasone dipropionate Formoterol fumarate Formoterol Beclomethasone dipropionate monohydrate Tiotropium bromide Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tiotropium+formoterol/beclomethasone run-in of 4 weeks with thiotropium cross-over after first treatment period of 4 weeks	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)
Sham Comparator: tiotropium+placebo cross-over cfr arm1	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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466712

Locations

Belgium
University Hospitals Leuven
Leuven, Flanders, Belgium, 3000

Sponsors and Collaborators

Katholieke Universiteit Leuven

Chiesi Farmaceutici S.p.A.

Investigators

Principal Investigator:

Marc Decramer, Md, PhD

University Hospitals Leuven

More Information

No publications provided

Responsible Party:	Marc Decramer, Principal Investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT01466712 History of Changes
Other Study ID Numbers:	S53020
Study First Received:	November 4, 2011
Last Updated:	November 8, 2011
Health Authority:	Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:

Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Beclomethasone
Formoterol
Tiotropium
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Parasympatholytics
Cholinergic Antagonists

ClinicalTrials.gov processed this record on June 18, 2013