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

NCT ID: NCT00910793

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inuvair

Group Type: OTHER

Inuvair

Intervention Type: DRUG

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

Interventions

Inuvair

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Wilfried De Backer

OTHER

Sponsor Role: lead

Responsible Party

Wilfried De Backer

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wilfried A De Backer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Antwerp, Antwerp, Belgium

Countries

Belgium

Other Identifiers

Eudract number: 2008-002391-97

Identifier Type: -

Identifier Source: secondary_id

PML_DOC_0802

Identifier Type: -

Identifier Source: org_study_id