A DOUBLE BLIND, DOUBLE DUMMY, GROUP COMPARATIVE STUDY TO ASSESS THERAPEUTIC EQUIVALENCE OF A NEW GENERIC FORMOTEROL 12 uG DRY POWDER FORMULATION WITH OXIS 12uG TURBUHALER IN ADOLESCENT AND ADULT ASTHMATIC PATIENTS
- Conditions
- asthma bronchiale
- Registration Number
- EUCTR2006-000683-84-SK
- Lead Sponsor
- Andi-Ventis Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
At study entry:
1.Subject has given written informed consent.
2.Female or male subject from 16 - 65 years of age.
3.Documented history of asthma for at least 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 >40% of the predicted normal FEV1 after withholding short-acting inhaled ß-agonists
for at least 6 hours and long-acting ß-agonists for 24 hours.
6.Subjects who demonstrate at study entry airway reversibility (increase in FEV1 > 12.00%
of the predicted value with a baseline FEV1 > 1.3 L and an increase of at least 0.200 L) 15 minutes following inhalation of 1 dose of 12ug formoterol from Oxis Turbuhaler ® after withholding
short-acting inhaled ß-agonists for at least 6 hours and long-acting ß2-agonists for 24 hours.
7.Have a Peak Inspiratory Flow between 30 and 90 L/min inclusive measured with the IN-Check device.
8.Subjects are able to use dry powder inhalers with a satisfactory technique.
9.Subjects are able to use the peak flow meter correctly and can produce reliable PEFR readings.
10.Subjects are able to fill in and maintain a Diary Card.
11.Subjects are able to fill in a Questionnaire related to usability of the inhalers.
12.In the opinion of the investigator, subjects understand the trial procedures and are willing to complete the diary card.
At start of treatment:
1. Subjects with an FEV1 of at least 40% predicted normal value for age, height and
gender after withholding short acting ß2-agonists for 6 hours and long acting
ß2-agonists for the duration of the baseline period..
2. Subjects who demonstrate airway reversibility (increase in FEV1 >12.00% of the
predicted value with a baseline FEV1 > 1.3 L and an increase of at least 0.200 L) 15
minutes following inhalation of the first doses of 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? yes
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)
F.1.3.1 Number of subjects for this age range
At study entry:
1.Patients currently 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 three short courses of oral corticosteroid therapy in the last year.
2.Patient currently receiving the following medications:
-Anticholinergics
-Theophylline and other methylxanthines
-Use of Monoamine-Oxidase inhibitors or tricyclic antidepressants.
-Use of beta-receptor blocking agents like beta-blocking anti-hypertensive products.
-Use of Leukotriene-antagonists, either currently or during the last week preceding the screening visit.
-Use of 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 therapy in the month prior to the start of the study.
4.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.
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 pack years.
7.Patients with any of the following concurrent conditions:
•Uncontrolled diabetes mellitus
•Evidence or history of neoplastic disease other than basal cell carcinoma
•Evidence or history of tuberculosis
•Evidence or history of significant cardiovascular disease
•Respiratory disorders other than asthma or rhinitis
•Clinically significant hepatic or renal disease
•Evidence or history of alcohol or drug abuse
8.Women who are pregnant or lactating. Women of child bearing potential and who are not taking adequate contraceptive precautions which were started at least 3 months prior to participation in the study.
9.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 medication or who have received investigational medication in the month prior to the start of the study.
11.Patients previously randomised into this study.
12.Employees of Andi-Ventis or CRO responsible for the execution of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method