Open-label, prospective study to assess the effects of formoterol and beclometasone dipropionate combination therapy on central and peripheral airway dimensions in asthmatic patients

niversity Hospital Antwerp; Department Respiratory Medicine0 sitesJune 16, 2008

DrugsInuvair

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Hospital Antwerp; Department Respiratory Medicine
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 16, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Hospital Antwerp; Department Respiratory Medicine

Eligibility Criteria

Inclusion Criteria

•1\.Patients with asthma as defined by the current GINA guidelines12 (for details of diagnosis of asthma please refer to the addendum in section 15\)
•Patients can belong to 3 categories:
•?Group 1 (n\=8\): Steroid naïve patients, not using IHC during the last 2 months and not controlled with symptomatic use of SABA
•?Group 2 (n\=14\): Patients not well controlled (partially controlled or uncontrolled according to the GINA guidelines) when using medium daily dose of inhaled corticosteroids and long acting inhaled ß2 agonists (for definition please refer to the addendum in section 15\) given for at least 6 weeks in a powder inhaler
•?Group 3 (n\=14\): Patients well controlled (according to GINA guidelines) when using medium daily dose of inhaled corticosteroids and long acting inhaled ß2 agonists (for definition please refer to the addendum in section 15\) given for at least 6 weeks in a powder inhaler
•From group 1, 2 patients and from group 2 and 3 , 3 patients will at random be assigned to subgroup 2\.
•2\.Male or female patients aged \=18 years
•3\.Patients with a documented positive response to the reversibility test (i.e. FEV1 increase \= 12% and 200mL from baseline value after 4 puffs of 100 µg of inhaled salbutamol pMDI) within the 12 months preceding the screening visit or performed at screening visit after a wash\-out of 2 days for long acting ß2 agonists or a documented positive response to the methacholine challenge test
•4\.Patients with a co\-operative attitude and ability to be trained to correctly use the pMDI
•5\.Written informed consent obtained

Exclusion Criteria

•1\.Pregnant or lactating females or females at risk of pregnancy
•2\.Inability to carry out pulmonary function testing
•3\.Diagnosis of COPD as defined by the current GOLD guidelines13
•4\.History of near fatal asthma
•5\.Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
•6\.Current smokers or recent (less than one year) ex\-smokers, defined as smoking at least 10 cigarettes/day
•7\.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
•8\.Patients with a QTc interval (Bazett’s formula) at the screening visit ECG test \>450 msec
•9\.Cancer or any other chronic disease with poor prognosis and /or affecting patient status
•10\.History of alcohol or drug abuse