A 8-week, multicentre, randomized, double-blind, double-dummy, parallel group, non-inferiority study, comparing Formoterol (Formopen®) administered via Elpenhaler® Dry Powder Inhaler versus the innovative Formoterol (Foradil®) administered via Aerolizer® in patients with mild to moderate persistent asthma.

• Conditions: Patients with mild to moderate persistent asthma, as defined by GINA criteria

• Registration Number: EUCTR2007-002157-23-GR
• Lead Sponsor: Elpen Pharmaceutical Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Study subjects are eligible for participation if they meet all of the following criteria:
At study entry
Visit 1 - Screening visit
1.Male or female subjects aged from 18 to 65 years old
2.Subject has signed the written informed consent
3.Documented history of mild to moderate persistant asthma (according to GINA criteria in Appendix 2) of = 6 months at the screening visit
4.Concurrent use of a short acting inhaled ß2-agonist for symptom relief and inhaled corticosteroids as maintenance treatment
5.Have an FEV1 >60% of the predicted normal FEV1 after withholding short-acting inhaled ß2-agonists for at least 6 hours and long-acting ß2-agonists for at least 24 hours
6.Demonstrate at study entry airway reversibility (increase in FEV1 >12% of the pre-medication value and an absolute increase of at least 0.200 lt) 15 minutes after the inhalation of 400 µg salbutamol, after withholding short-acting inhaled ß2-agonists for at least 6 hours and long-acting ß2-agonists for at least 24 hours
7.Have a PIF between 30 and 90 Lt/min measured with the InCheck (Clement Clark, UK) device
8.Able to use both types of inhalers with a satisfactory technique
9.Able to use a peakflow meter correctly and can produce reliable PEFR readings
10.In the opinion of the investigator, subjects are able to fill and maintain a diary card, to fill a Questionnaire related to the usability of the inhalers, and understand the procedure of the specific trial.

At baseline visit
Visit 2- Randomisation visit

1.Have FEV1 of at least 60% of the predicted value for age, height and gender after withholding for 6 hours from short acting ß2-agonists and from long acting agonists for the duration of the baseline period (at least 14 days plus a maximum of 3 days).
2.Demonstrate airway reversibility (increase in FEV1 >12% of the predicted value and an absolute increase of at least 0.200 lt) 15 minutes after the inhalation of 1 dose of 12 µg formoterol (study medication), after withholding short-acting inhaled ß2-agonists for at least 6 hours and long-acting ß2-agonists for the duration of the baseline period.

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

Patients who meet any of following exclusion criteria are not eligible for randomisation into the study:

At study entry
Visit 1- Screening visit
1.Patients receiving oral corticosteroid therapy or who have received oral corticosteroid therapy in the 3 months prior to the start of this study, or who have received more than 3 short courses (up to 5 days each) of oral corticosteroid therapy in the last year
2.Patients currently receiving any of the following medications
a.anticholinergics
b.theophylline or methylxanthines
c.cromones
d.mono-amino oxidase inhibitors or tricyclic antidepressants
e.use of oral or topical beta-blockers agents (like antihypertensive drugs or eye drops)
f.use of leukotriene antagonists, either currently or during the last week preceding the screening visit
3.Patients currently receiving therapy for an upper respiratory tract infection
4.Patients who have been hospitalized or received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study
5.Patients with a known or suspected hypersensitivity to formoterol, salbutamol or lactose
6.Heavy smokers (> 10 cigarettes per day) or ex smokers who smoked more than 10 packs years
7.Patients with any of the following concurrent conditions
a.uncontrolled diabetes melitus
b.evidence or history of neoplastic disease other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the uterine cervix
c.evidence or history of tuberculosis
d.evidence or history of ischaemic heart disease, severe heart failure, myocardial infarction, tachyarrhythmias, cardiac arrhythmias, third degree atrioventricular block, decompensated heart failure, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe hypertension, prolongation of the QTc>0.44s, aneurysm, convulsive disorders, thyreotoxicosis, pheochromocytoma.
e.respiratory disorders other than asthma or rhinitis
f.clinically significant hepatic (transaminase level more than 2 times higher than the normal values) or renal disease (creatinine clearance less than 10 ml/min)
g.evidence of history of alcohol or drug abuse
8.Female patients that are pregnant or lactating. Women of childbearing potential that refuse to take adequate contraceptive precautions
9.In the opinion of the investigator, patients who are unlikely to be compliant, take their medication as directed, complete the diary card or attend scheduled clinic visits as required
10.Patients currently receiving other investigational drugs or who have received investigational medication in the month prior to the start of the study
11.Patients previously randomized into this study
12.Employees of Elpen or CROs or hospitals or any other organization involved in the study

Visit 2-At baseline visit
1.Patients with a pre-dose FEV1 variation more than + 15% of the respective FEV1 measured in the previous visit.
2.Use of oral or topical long acting ß2 agonists during the baseline period
3.Patients currently receiving therapy for an upper respiratory tract infection or who have received such a treatment in the month prior to visit 2
4.Poor compliance during the run-in period

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess therapeutic equivalence of the new generic 12µg dry powder formoterol formulation (Formopen®) compared to the reference formoterol formulation (Foradil®).;Secondary Objective: To evaluate the safety and tolerability of the new generic 12µg dry powder formoterol formulation. <br>To evaluate the sustained bronchodilation of the new generic 12µg dry powder formoterol<br>;Primary end point(s): The primary study variable will be the change of mean mPEFR as defined by the following variables: mean mPEFR at baseline and mean mPEFR at the end of study period.