reversible mild asthma
Conditions
Interventions
Product Name: formoterol
Product Code: MIAT HALER
Pharmaceutical Form: Inhalation powder
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical Form: Inhalation powder
Sponsors
Andi - Ventis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 b2-agonists for at least 6 hours and long acting b2- agonists for at least 24 hours. 4. Subjects who demonstrate a reversibility of > 12.00% (of the predicted value) in FEV1 10 minutes after a dose of 12mg 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
Exclusion criteria
Exclusion criteria: 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 or concomitant use of non-potassium sparing diuretics · Use of Mono-Amine-Oxydase inhibitors or tricyclic antidepressants. · Use of Leukotriene-antagonists, either currently or during the last week preceding the screening visit. · Use of non-selective beta-receptor blocking agents like beta-blocking antihypertensive products. 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 10.00% of the value obtained at the Screening Visit. 2. Use of short-acting b2 agonists in the 6 hours preceding this visit or long-acting b2 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To evaluate the general safety and tolerability of the new generic formoterol dry powder formulations in comparison with the reference formoterol formulations. 2. To evaluate the potential tendency to decrease potassium plasma levels and the potential tendency to increase glucose plasma levels of the new generic formoterol dry powder formulations in comparison with the reference formoterol formulations;Secondary Objective: To confirm clinical equivalence/comparability of the new generic formoterol dry powder formulation at two strengths (6mg and 12mg) compared to reference formoterol formulations given in a cumulative dose design;Primary end point(s): To evaluate the general safety and tolerability of the new generic formoterol dry powder formulations in comparison with the reference formoterol formulations. To evaluate the potential tendency to decrease potassium plasma levels and the potential tendency to increase glucose plasma levels of the new generic formoterol dry powder formulations in comparison with the reference formoterol formulations | — |
Countries
Hungary
Outcome results
None listed