A 26 week treatment, multi center, randomized, double-blind, double dummy, parallel group study with to assess the safety of indacaterol (300 and 600 ug o.d.) in patients with persistent asthma, using salmeterol (50 ug b.i.d.) as an active control. - ND
- Conditions
- moderate to severe persistent asthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2007-001005-16-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
1. Male and female patients aged ≥ 12 years who have signed an Informed Consent form prior to initiation of any study-related procedure. In the case of patients below the legal parent/guardian. 2. Patients with moderate to severe persistent asthma, diagnosed according to GINA guidelines (Updated 2006) and who additionally meet the following criteria: a) Patients who have used treatment with a bronchodilator, either regularly or on-demand, and who have used a daily dose of at least 100 µg BDP or equivalent dose of an alternative ICS (up to the maximum daily dose as recommended in the package leaflet) for at least one month prior to Visit 1. The ICS dose must have been stable during this period and must be expected to remain stable throughout the study. b) Patients whose FEV1 is ≥50% of the predicted normal value for the patient, allowing for race correction if appropriate, at both Visit 1 and Visit 2. This criterion for FEV1 is to be demonstrated after an appropriate washout period for all bronchodilators (e.g. at least six hours for short-acting bronchodilators such as albuterol and 48 hours for long acting bronchodilators such as salmeterol and formoterol) prior to the evaluation. c) Patients with documented (in the previous 6 months) or who demonstrate (prior to visit 2) a ≥12% and at least 200 ml increase in FEV1, over their pre-bronchodilator value within 30 minutes after inhaling a total of 200/180 µg salbutamol/albuterol (i.e. two inhalations), demonstrated after an appropriate washout period for all bronchodilators (e.g. at least six hours for short-acting bronchodilators such as albuterol and 48 hours for long acting bronchodilators such as salmeterol and formoterol) prior to the evaluation.
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) yes
F.1.3.1 Number of subjects for this age range
1. 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 serum hCG laboratory test (> 5 IU/ml) 2. Women of child-bearing potential, 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 postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m OR are using one or more of the following acceptable methods of contraception a) surgical sterilization (e.g., bilateral tubal ligation) b) hormonal contraception (implantable, patch, oral) c) double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). For females aged 12 to 17 years acceptable methods of contraception may include total abstinence at the discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation 3. Patients who have used tobacco products within the 12 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked). 4. Patients who suffer from COPD as diagnosed by the GOLD guidelines (2006). 5. Patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to Visit 1 or who have been hospitalized for an acute asthma attack in the 6 months prior to Visit 1, or at any time between Visit 1 and Visit 2. 6. Patients who have had a respiratory tract infection within 6-weeks prior to Visit 1. PLS SEE PROTOCOL
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