A RANDOMISED, FOUR WAY CROSS-OVER STUDY TO ASSESS THE BRONCHODILATING PROPERTIES OF A NEW GENERIC DRY POWDER FORMOTEROL FORMULATION GIVEN AS CUMULATIVE DOSES FROM A NOVEL DRY POWDER INHALER AND TWO REFERENCE DRY POWDER FORMULATIONS IN ADULT ASTHMATIC PATIENTS
- Conditions
- reversible mild asthma
- Registration Number
- EUCTR2005-003826-24-HU
- Lead Sponsor
- Andi - Ventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 32
At study entry:
1.Male and female asthmatic patients, aged 18 - 55 years inclusive.
2. Documented asthma for at least 6 months before screening.
3.Subjects with a FEV1 > 50% of the predicted normal value for age, height and gender after withholding short acting Beta2-agonists for at least 6 hours and long acting Beta2-agonists for at least 24 hours.
4.Subjects who demonstrate a reversibility of > 12% (of the predicted value) in FEV1 10 minutes after a dose of 12ug formoterol from the Aerolizer.
5.Subjects who are able to handle dry powder inhalers correctly.
6.Subjects who are able to perform lung function tests properly.
7.Subjects who are willing to give written informed consent to participate in the study.
On study days:
1.A pre-dose baseline FEV1 within 10% of the value obtained at the Screening Visit.
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
1.Patients currently receiving oral corticosteroid therapy or who have received oral corticosteroid therapy in the 3 months preceding the screening.
2.Patients currently receiving therapy for an upper respiratory tract infection or who have received such a therapy in the month prior to the start of the study.
3.Patients who have been hospitalised or received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study.
4.Patients with a known or suspected hypersensitivity to formoterol or its recipients.
5.Patients who are unable to perform lung function tests.
6.Patients with any of the following concurrent conditions:
•Uncontrolled diabetes mellitus
•Evidence of current neoplastic disease other than basal cell carcinoma
•Evidence of tuberculosis
•Evidence of significant cardiovascular disease
•Respiratory disorders other than asthma or rhinitis
•Significant hepatic or renal insufficiency.
•Evidence or history of alcohol or drug abuse.
•Evidence or history of low potassium levels.
•Use of Mono-Amine-Oxydase inhibitors or tricyclic antidepressants.
•Use of Leukotriene-antagonists, either currently or during the last week preceding the screening visit.
7.Patients currently receiving other investigational medication or who have received investigational medication in the month prior to the screening of the study.
8. Employees of the Sponsor or the CRO responsible for the execution of the study.
9. Women who are pregnant, lactating or likely to become pregnant during the course of
the study. Women of child bearing potential will be eligible to enter the study if using
adequate contraception (i.e. contraceptive pill or barrier methods).
On study days:
1.A pre-dose baseline FEV1 outside 10% of the value obtained at the Screening Visit.
2.Use of short-acting Beta2 agonists in the 6 hours preceding this visit or long-acting Beta2 agonists in the 24 hours preceding this visit.
3.Any clinically significant abnormality following the investigator’s review of the clinical laboratory test done at the previous visit.
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 a new generic formoterol dry powder formulation at two strengths (6 microgramm and 12 microgramm) compared to reference formoterol formulations given in a cumulative dose design;Secondary Objective: To evaluate the safety and tolerability of the new generic formoterol dry powder formulations.;Primary end point(s): To assess therapeutic equivalence of a new generic formoterol dry powder formulation at two strengths (6ug and 12ug) compared to reference formoterol formulations given in a cumulative dose design
- Secondary Outcome Measures
Name Time Method