Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Asthmatic Patients

NCT00910793 | Completed Phase 4

• 2 other identifiers: PML_DOC_0802Eudract number: 2008-002391-97
• 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 asthmatic patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and resistance) and subjective asthma control score as well as the safety of this combination will be assessed.

Conditions

Asthma

Keywords

Asthma; Formoterol; Beclomethasone Dipropionate; Computational Fluid Dynamics; Functional Imaging; Central and Peripheral Airways

Outcome Measures

Primary Outcomes (1)

• Differences in airway dimension

  The primary objective of this study is to evaluate the effect of the combination therapy on central and peripheral airway dimensions with CFD. The following primary outcome parameters will be determined: * Total airway resistance for the segmented airways * Peripheral airway resistance(from 4th bifurcation on) for the segmented airways * Total airway volume for the segmented airways * Peripheral airway volume (from the 4th bifurcation on) for the segmented airways * Relative compliance for each lobe * Density of the lung parenchyma given per predefined lung zone

  airway dimension will be measured at visit 2 and visit 7

Secondary Outcomes (4)

• Lung function tests: dynamic lung volumes, static lung volumes and airway resistances

  lung function tests will be perfomed at te following visits: screening, visit 1 (2 weeks after screening), visit 3 (6 weeks after screening), visit 5 (14 weeks after screening) and visit 7 (26 weeks after screening)

• Subjective asthma control score

  Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7

• Exhaled Nitric Oxide (NO)

  Exhaled NO will be measured on visit 2, 3, 5 and 7

• Adverse events as a measure of safety

  Follow up of adverse events will be done during the entire study duration

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

You may qualify if:

• Patients with asthma as defined by the current Global INitiative for Asthma (GINA) guidelines:
• Male or female patients aged ≥18 years
• Patients with a documented positive response to the reversibility test within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting β2 agonists or a documented positive response to the methacholine challenge test
• Patients with a co-operative attitude and ability to be trained to correctly use the pressurized Metered Dose Inhaler (pMDI)
• Written informed consent obtained

You may not qualify if:

• Pregnant or lactating females or females at risk of pregnancy
• Inability to carry out pulmonary function testing
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines
• History of near fatal asthma
• Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
• Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day
• 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 8 weeks prior to the screening visit
• Patients treated with any non-permitted concomitant medication

Sponsors & Collaborators

• Wilfried De Backer: lead
• UCB Pharma: collaborator

Study Sites (1)

University Hospital Antwerp

Antwerp, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wilfried A De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 1, 2009
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

BE (1)