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Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01204034

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-06-30

Brief Summary

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The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Formoterol Beclomethasone Dipropionate Computational Fluid Dynamics Functional Imaging Central and Peripheral Airways BODE index COPD Assessment Test (CAT) Borg CR10 scale

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inuvair

Group Type OTHER

Inuvair

Intervention Type DRUG

6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

Interventions

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Inuvair

6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC \< 0.70

* Male or female patients aged ≥ 40 years
* Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines
* Patients who present
* Moderate COPD with an FEV1 between 50 and 80% of predicted GOLD 2)
* Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)
* Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)
* Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
* Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
* Written informed consent obtained

Exclusion Criteria

* Pregnant or lactating females or females at risk of pregnancy
* Unstable patients who developed an exacerbation during the last 4 weeks
* Inability to carry out pulmonary function testing
* Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines
* Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
* Patients with a QTc interval (Bazett's formula) at the screening visit electrocardiogram (ECG) test \>450 msec
* Cancer or any other chronic disease with poor prognosis and /or affecting patient status
* History of alcohol or drug abuse
* Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
* Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
* Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
* Patients treated with any non-permitted concomitant medication
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Wilfried De Backer

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wilfried A De Backer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Antwerp

Locations

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University Hospital of Antwerp

Edegem (Antwerp), Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2010-019864-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PML-DOC-1003

Identifier Type: -

Identifier Source: org_study_id