A RANDOMISED, DOUBLE-BLIND, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO ASSESS THE BRONCHODILATING PROPERTIES OF A NEW GENERIC DRY POWDER FORMOTEROL FORMULATION GIVEN FROM A NOVEL DRY POWDER INHALER COMPARED TO THE REFERENCE FORADIL® AEROLIZER® IN MODERATE TO SEVERE ADULT ASTHMATIC SUBJECTS
- Conditions
- This study has been initianed to assess the bronchodilating properties of a new generic dry powder formoterol formulation given from a novel dry powder inhaler compared to the reference Foradil Aerolizer in moderate to severe adult asthmatic subjects.
- Registration Number
- EUCTR2007-003872-20-HU
- Lead Sponsor
- aboratorios Liconsa S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
At study entry:
1.Subjects who are willing to give written informed consent to participate in the study.
2.Male and female asthmatic subjects, legally aged 18 - 75 years, inclusive.
3.Documented asthma for at least 6 months before screening as per the current GINA guidelines, treated with or without the use of inhaled corticosteroids. Patients on inhaled corticosteroids must have followed a stable treatment regimen for at least the previous 4 weeks prior to the Screening Visit
4.Subjects with a baseline FEV1 40% - 70% of the predicted normal value for age, height and gender after withholding short acting beta2-agonists/anticholinergics for at least 8 hours and methylxanthines, long acting ?2-agonists/ anticholinergics for at least 32 hours. Qualifying lung function parameters will be measured using standardized equipment for all participating centres. Appropriate standard formulae from the European Community for Coal and Steel (Quanjer et al., 1993) will be used for the calculation of the predicted FEV1 values. The reference (ECCS) values will be generated by the specific spirometer provided by the Sponsor to the investigator.
5.Subjects who demonstrate a reversibility in airway obstruction (increase in FEV1 of ? 15% and an increase of at least 250 ml over pre-salbutamol values) 30 minutes after the inhalation of a dose of 200?g salbutamol from a standard pMDI.
6.Subjects who are able to handle dry powder inhalers correctly.
7.Subjects who are able to perform lung function tests properly.
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) yes
F.1.3.1 Number of subjects for this age range
Subjects will be excluded from participation if any of the following apply:
1.Subjects currently receiving oral, intravenous or intramuscular corticosteroid therapy or who have received such corticosteroid therapy in the 3 months preceding the screening or who have received more than 3 short courses of such therapy in the last year.
2.Subjects 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. Subjects who require such a treatment during the run-in or washout periods will be discontinued from the trial.
3.Subjects who have been hospitalized or have received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study. Subjects who require such a treatment during the run-in or washout periods will be discontinued from the trial.
4.Subjects with a known or suspected hypersensitivity to formoterol or other ß2-receptor agonists or any other ingredients of the study medications.
5.Subject who show signs of paradoxical bronchospasm after salbutamol inhalation (defined as having the lowest FEV1 within 30 minutes after inhalation smaller or equal to the lowest pre-dose baseline FEV1).
6.Subjects with any of the following concurrent conditions:
•Uncontrolled diabetes mellitus defined as fasting plasma glucose ?10 mmol/L
•Evidence of current 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 allergic rhinitis
•Clinically significant hepatic or renal disease
•Evidence or history of alcohol or drug abuse
•Evidence or history of low potassium levels (i.e., potassium values below the lower limit of normal, as per the central laboratory results at the Screening Visit) or concomitant use of non-potassium sparing diuretics.
7.Subjects currently receiving or who intend to receive during the study any of the following medications, except what is specifically permitted during the run-in and/or washout periods:
•Mono-amine-oxidase inhibitors or tricyclic anti-depressants
•Leukotriene-antagonists, either currently or during the last week preceding the screening visit
•Non-selective beta-receptor blocking agents
•Use of anticholinergics, other inhaled ?2-agonists or methylxanthines:
These medications are permitted during the run-in and washout periods, provided that a washout period of at least 8 hours prior to screening and both treatment days is adhered to for short acting anticholinergics/short acting ?2-agonists and a washout period of 32 hours prior to screening and both treatment days is adhered to for methylxanthines/long acting beta2-agonists/ long acting anticholinergics.
•Oral beta2-agonists. A washout period of 72 hours is required prior to the screening visit.
•Use of any other medications that contain products known to have ß2-agonistic activity (i.e. ephedrine):
A washout period of 72 hours prior to screening is required.
8.Heavy smokers defined as smoking at least 10 cigarettes per day or ex-smokers who smoked more than 10 pack years.
Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history
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 Liconsa 12 µg dry powder formoterol inhalation product compared to a reference formoterol product (Foradil? Aerolizer?) given in a crossover, single-dose design.;Secondary Objective: To evaluate the safety and tolerability of the Liconsa 12 µg dry powder formoterol inhalation product compared to a reference formoterol product (Foradil? Aerolizer?)<br><br>;Primary end point(s): The primary aim of the study is to assess therapeutic equivalence of the Liconsa 12 µg dry powder formoterol inhalation product compared to a reference formoterol product (Foradil Aerolizer) given in a crossover, single-dose design<br>
- Secondary Outcome Measures
Name Time Method