Asthma MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Foradil Concept 1
Product Code: FOR258
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Formoterol fumarate 2 H2O
CAS Number: 43229-80-7
Current Sponsor code: FO
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female adult and adolescent patients aged 13 years and over, who have signed an Informed Consent Form prior to initiation of any study-related procedure. In the case of patients below the legal age of consent, the Informed Consent Form should also be signed by the patient’s parent / guardian. Patients with stable mild or moderate persistent asthma, diagnosed according to GINA guidelines [National Institutes of Health. National Heart, Lung and Blood Institute. (OCT 2005)] and who additionally meet the following criteria: •Patients receiving daily treatment with anti-inflammatory asthma medication, in a stable regimen for the month prior to Visit 1. •Patients whose FEV1 at Visit 2 is >= 60% of his/her predicted normal value. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6-hours during which no shortacting ß2-agonist has been inhaled, and 48 hours for a long-acting ß2-agonist . •Patients who demonstrate an increase of >=15% or 200ml in FEV1 over their pre-treatment value within 30 minutes after inhalation of 400 µg (4 x 100 µg inhalations) of salbutamol (the administration of salbutamol for the reversibility test has to be within 30 minutes of pre-treatment spirometry).Reversibility will have to be demonstrated at Visit 2 only, after a washout period of at least six hours prior to the evaluation for a short-acting ß2-agonist and 48 hours for a long-acting ß2- agonist. 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
Exclusion criteria
Exclusion criteria: •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml) •Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To demonstrate that each dose of formoterol delivered by Concept1 is equivalent to the corresponding dose of formoterol delivered by the Aerolizer® in terms of serial measurements of FEV1 following inhalation of a single dose;Main Objective: To compare the efficacy of two doses of formoterol, 12µg and 24µg, delivered by Concept1 with corresponding doses of formoterol delivered by Aerolizer® in terms of bronchodilator efficacy in patients with persistent asthma by testing the hypotheses: •Formoterol Concept1 12µg is equivalent to formoterol Aerolizer® 12µg in terms of FEV1 AUC over 12 hours following inhalation of a single dose; •Formoterol Concept1 24µg is equivalent to formoterol Aerolizer® 24µg in terms of FEV1 AUC over 12 hours following inhalation of a single dose; ;Primary end point(s): The primary variable for analysis will be the 12 hour Area Under the Curve (AUC) of FEV1 following a single dose of study medication standardized with respect to length of time completed in the observation period (expressed in L) without intake of rescue medication. The primary objective will be addressed by testing the following hypotheses: •Formoterol Concept1 12µg is equivalent to formoterol Aerolizer® 12µg in terms of FEV1 AUC over 12 hours following inhalation of a single dose; •Formoterol Concept1 24µg is equivalent to formoterol Aerolizer® 24µg in terms of FEV1 AUC over 12 hours following inhalation of a single dose; Initially the equivalence of the 12µg doses delivered by the two devices will be tested and if established, the equivalence of the 24µg doses will be tested. However if the first hypothesis is not accepted the second will not be addressed. Treatment comparisons will be tested on the ITT population but because of the cross-over nature of the study, only patients who have received at least two different randomized treatments will contribute data to the analyses. Equivalence of the same doses of formoterol delivered by the two devices w | — |
Countries
Germany
Outcome results
None listed