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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Terminated

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

Foster® 100/6 µg/unit dose

Symbicort® Turbohaler® 200/6 μg/actuation

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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).
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:

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.
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.
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.
Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
Major surgery in the previous 3 months and during the trial which may affect patient's compliance in study procedures (e.g. plethysmography).
Patients requiring chronic mechanical ventilation for COPD.

Sites / Locations

Department of Pulmonary Diseases - University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Foster®

Symbicort® Turbohaler®

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change from baseline to end of treatment in post-dose residual volume.

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.

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);

Changes from baseline in COPD symptom scores (for each single score and the total score);

Change from baseline in percentage of COPD symptom-free days;

Change from baseline in rescue salbutamol or ipratropium bromide consumption (puffs per day);

Change from baseline in percentage of rescue salbutamol or ipratropium bromide-free days;

Transition Dyspnoea Index (TDI) score;

Clinical COPD Questionnaire (CCQ);

Physical activity (by means of pedometer);

Nasal brushing (mRNA expression);

Number of patients with COPD exacerbations.

Full Information

NCT ID

NCT01351792

First Posted

May 10, 2011

Last Updated

March 28, 2017

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01351792

Brief Title

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

Acronym

FAIR

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Study Start Date

September 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Foster®

Arm Type

Experimental

Arm Description

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).

Arm Title

Symbicort® Turbohaler®

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Foster® 100/6 µg/unit dose

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Symbicort® Turbohaler® 200/6 μg/actuation

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change from baseline to end of treatment in post-dose residual volume.

Time Frame

At day 84

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Changes from baseline in COPD symptom scores (for each single score and the total score);

Time Frame

At day 84

Title

Change from baseline in percentage of COPD symptom-free days;

Time Frame

At day 84

Title

Change from baseline in rescue salbutamol or ipratropium bromide consumption (puffs per day);

Time Frame

At day 84

Title

Change from baseline in percentage of rescue salbutamol or ipratropium bromide-free days;

Time Frame

At day 84

Title

Transition Dyspnoea Index (TDI) score;

Time Frame

At day 84 (V4)

Title

Clinical COPD Questionnaire (CCQ);

Time Frame

At screening (day -28), at baseline (day 0) and at the end of trial (day 84)

Title

Physical activity (by means of pedometer);

Time Frame

Each day of the two weeks before each clinic visit

Title

Nasal brushing (mRNA expression);

Time Frame

At screening (day -28), at baseline (day 0) and at the end of trial (day 84)

Title

Number of patients with COPD exacerbations.

Time Frame

From pre-screening (day -35) to the end of trial (day 84)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Outpatients with a clinical diagnosis of moderate to severe COPD and including: 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. Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1. Post-bronchodilator FEV1 < 65% of the predicted normal value at visit 1. Post-bronchodilator FEV1/FVC < 0.7 at visit 1. An increase in FEV1 < 15% and < 200 mL from baseline following administration of 400 µg of salbutamol at visit 1. Plethysmographic Functional Residual Capacity (FRC) > 120% of the predicted normal value (at visit 1 and visit 2). A Baseline Dyspnoea Index (BDI) focal score less or equal to 10 (at visit 1 and at visit 2). 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: 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. 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. 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. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period. Major surgery in the previous 3 months and during the trial which may affect patient's compliance in study procedures (e.g. plethysmography). Patients requiring chronic mechanical ventilation for COPD.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dirkje Postma, MD

Organizational Affiliation

Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marteen van den Berge, MD

Organizational Affiliation

Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pulmonary Diseases - University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9713

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

33060632

Citation

Faiz A, Imkamp K, van der Wiel E, Boudewijn IM, Koppelman GH, Brandsma CA, Kerstjens HAM, Timens W, Vroegop S, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Steiling K, Spira A, Lenburg ME, Heijink IH, Postma DS, van den Berge M. Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD. Sci Rep. 2020 Oct 15;10(1):17415. doi: 10.1038/s41598-020-72551-0.

Results Reference

derived

PubMed Identifier

29268739

Citation

Boudewijn IM, Faiz A, Steiling K, van der Wiel E, Telenga ED, Hoonhorst SJM, Ten Hacken NHT, Brandsma CA, Kerstjens HAM, Timens W, Heijink IH, Jonker MR, de Bruin HG, Sebastiaan Vroegop J, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Spira A, Lenburg ME, Guryev V, Postma DS, van den Berge M. Nasal gene expression differentiates COPD from controls and overlaps bronchial gene expression. Respir Res. 2017 Dec 21;18(1):213. doi: 10.1186/s12931-017-0696-5.

Results Reference

derived

Links:

URL

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-022895-30

Description

Study Record on EU Clinical Trials Register including results

Learn more about this trial

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

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