Randomised, double-blind, double-dummy, cross-over trial comparing a novel DPI with formoterol versus Oxis Turbohaler 12 µg in patients with stable persistent asthma - Inhalatorstudie Formoterol DPI

• Conditions: Adult patients with stable persistent asthma; MedDRA version: 9.0Level: LLTClassification code 10049106

• Registration Number: EUCTR2006-001141-34-DE
• Lead Sponsor: ABOpoint GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All of the following criteria have to be met for inclusion of a subject in the study:

- men or women aged between 18 and 65 years
- written informed consent of patient
- current diagnosis of persistent asthma according to generally acknowledged criteria
- stable daily regimen of anti-inflammatory therapy (such as inhaled corticosteroids) upon at least 4 weeks
- a forced expiratory volume in one second (FEV1) between 40 and 90% of the predicted normal value
- documented FEV1-reversibility of at least 12%
- capable of understanding the directions for device usage

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are to be excluded from the study when one or more of the following conditions are met:
- respiratory tract infection less than 6 weeks prior to study entry
- acute asthma attack, which led to hospitalisation less than 1 month prior to study entry
- smokers less than 6 weeks prior to study entry
- medical history of cystic fibrosis or bronchiectasis
- systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 95mm Hg and heart rate > 100 bpm
- known hypersensitivity to formoterol or any of the ingredients of the study medication
- thyrotoxicosis, pheochromocytoma, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, aneurysm or other severe cardiovascular disorders
- clinically significant conditions that might compromise patient safety, patient compliance, interfere with evaluations or preclude completion of the trial
- previous treatment within one month prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, as for example: xanthine derivatives, diuretics, digitalis glycosides, antiarrhythmic agents like quinidine, disopyramide and procainamide, erythromycine, antihistamines with a potential for ventricular arrhythmias (i.e. terfenadine), tricyclic antidepressants, halogenated anaesthetics, beta-adrenergic blockers (including eye drops)
- abnormal 12-lead ECG at screening recorded after at least 5 min of rest in supine position
- prolonged QTc interval more than 460 ms for females and more than440 ms for males
- female patients: pregnancy or lactation
- history of alcohol and/or drug and/or substance abuse
- unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period
- current participation in another clinical study or former participation in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified