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A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01351792
First received: May 10, 2011
Last updated: December 10, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of the present study is to demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Foster® 100/6 µg/unit dose
Drug: Symbicort® Turbohaler® 200/6 μg/actuation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-week, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Puffs b.i.d., Versus Symbicort® 200/6 (Budesonide 200 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., on Parameters of Small Airway Function in Patients With Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Change from baseline to end of treatment in post-dose residual volume. [ Time Frame: At day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in FEV1, FVC, FEV1/FVC, IVC/FVC, RV, TLC, RV/TLC, FRC, FRC/TLC, RV/VC, Raw, eff and sGaw, eff. [ Time Frame: At day 84 ] [ Designated as safety issue: No ]
  • Changes from baseline in airways resistance (R5, R20, R5-20) and reactance at 5 Hertz (X5) (in a subset of at least 50% of patients from pre-selected sites); [ Time Frame: at day 84 ] [ Designated as safety issue: No ]
  • Changes from baseline in COPD symptom scores (for each single score and the total score); [ Time Frame: At day 84 ] [ Designated as safety issue: No ]
  • Change from baseline in percentage of COPD symptom-free days; [ Time Frame: At day 84 ] [ Designated as safety issue: No ]
  • Change from baseline in rescue salbutamol or ipratropium bromide consumption (puffs per day); [ Time Frame: At day 84 ] [ Designated as safety issue: No ]
  • Change from baseline in percentage of rescue salbutamol or ipratropium bromide-free days; [ Time Frame: At day 84 ] [ Designated as safety issue: No ]
  • Transition Dyspnoea Index (TDI) score; [ Time Frame: At day 84 (V4) ] [ Designated as safety issue: No ]
  • Clinical COPD Questionnaire (CCQ); [ Time Frame: At screening (day -28), at baseline (day 0) and at the end of trial (day 84) ] [ Designated as safety issue: No ]
  • Physical activity (by means of pedometer); [ Time Frame: Each day of the two weeks before each clinic visit ] [ Designated as safety issue: No ]
  • Nasal brushing (mRNA expression); [ Time Frame: At screening (day -28), at baseline (day 0) and at the end of trial (day 84) ] [ Designated as safety issue: No ]
  • Number of patients with COPD exacerbations. [ Time Frame: From pre-screening (day -35) to the end of trial (day 84) ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Foster®
Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).
 Drug: Foster® 100/6 µg/unit dose
Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).
Active Comparator: Symbicort® Turbohaler®
Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).
 Drug: Symbicort® Turbohaler® 200/6 μg/actuation
Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).

Detailed Description:

Chronic obstructive pulmonary disease (COPD) is an incurable, debilitating and progressive disease that can be fatal. The recent Global Burden of Disease Study ranks COPD as the 6th leading cause of mortality and the 12th leading cause of morbidity world-wide. Furthermore, trends in the use of medical care resources indicate that the economic cost of COPD continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative.

  2. Outpatients with a clinical diagnosis of moderate to severe COPD and including:

    1. Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20, both current and ex-smokers are eligible.
    2. Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1.
    3. Post-bronchodilator FEV1 < 65% of the predicted normal value at visit 1.
    4. Post-bronchodilator FEV1/FVC < 0.7 at visit 1.
    5. An increase in FEV1 < 15% and < 200 mL from baseline following administration of 400 µg of salbutamol at visit 1.
    6. Plethysmographic Functional Residual Capacity (FRC) > 120% of the predicted normal value (at visit 1 and visit 2).
    7. A Baseline Dyspnoea Index (BDI) focal score less or equal to 10 (at visit 1 and at visit 2).
  3. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Turbohaler®, inspiratory flow-driven, multidose powder inhaler) inhalers.

Main Exclusion Criteria:

  1. Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion.
  2. Clinically unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator's judgement.
  3. Patients with COPD exacerbation and/or symptomatic infection of the airways requiring antibiotic therapy (at least 5 days) in the 2 months prior to screening and during the study period.
  4. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
  5. Major surgery in the previous 3 months and during the trial which may affect patient's compliance in study procedures (e.g. plethysmography).
  6. Patients requiring chronic mechanical ventilation for COPD.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351792

Locations
Netherlands
Department of Pulmonary Diseases - University Medical Center Groningen
Groningen, Netherlands, 9713
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Study Chair: Dirkje Postma, MD Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands
Principal Investigator: Marteen van den Berge, MD Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01351792     History of Changes
Other Study ID Numbers: CCD-1007-PR-0045, 2010-022895-30
Study First Received: May 10, 2011
Last Updated: December 10, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Beclomethasone
Budesonide
Formoterol
Symbicort
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013