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

NCT01204034 | Completed Phase 3

• 2 other identifiers: PML-DOC-10032010-019864-36
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Peripheral airway resistance (from 4th bifurcation on) for the segmented airways

  at baseline and after 6 months of treatment

• Total airway volume for the segmented airways

  at baseline and after 6 months of treatment

• Peripheral airway volume (from the 4th bifurcation on) for the segmented airways

  at baseline and after 6 months of treatment

• Relative compliance for each lobe

  at baseline and after 6 months of treatment

• Density of the lung parenchyma given per predefined lung zone

  at baseline and after 6 months of treatment

• Total airway resistance for the segmented airways

  at baseline and after 6 months of treatment

Secondary Outcomes (15)

• BODE index

  at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)

• COPD assessment test

  at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)

• Borg CR10 Scale

  At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

• Adverse events as a measure of safety

  during the study patients will record record each day taken medication and any possible comments on the daily diary cards

• Forced expiratory volume in 1 second (FEV1)

  At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

Study Arms (1)

Inuvair

OTHER

Drug: Inuvair

Interventions

Inuvair DRUG

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

Inuvair

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (1)

University Hospital of Antwerp

Edegem (Antwerp), Antwerp, B-2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilfried A De Backer, MD PhD

  University Hospital of Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

BE (1)