A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 μg o.d. vs inhaled tiotropium 18 μg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD - ND
- Conditions
- COPDMedDRA version: 12.0Level: LLTClassification code 10009025Term: Chronic obstruct airways disease
- Registration Number
- EUCTR2008-007944-33-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure Co-operative outpatients with a diagnosis of severe COPD (severe as classified by the GOLD Guidelines, 2007 and including: a) Smoking history of at least 10 pack years b) Post-bronchodilator FEV1 <50% and ≥30% of the predicted normal value c) Post-bronchodilator FEV1/FVC <70% d) A documented history of at least 1 moderate or severe exacerbation in the previous 12 months. see Section 7.4.2 for the definition of a COPD exacerbation (Post refers to within 15 min of inhalation of 400 μg (4x100μg) of salbutamol, equivalent to 4 x 90 μg albuterol delivered at the mouthpiece, at Visit 2).
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 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 human chorionic gonadotrophin laboratory test (>5 mIU/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/mL or are using one or more of the following acceptable methods of contraception. a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy) 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) Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. 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 whose body mass index is less than 15 or greater than 40 kg/m2 4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD exacerbation). This is typically patients requiring oxygen therapy >15 h per day delivered by home oxygen cylinder or concentrator 5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. Patients who develop a respiratory tract infection between Visit 2 and Visit 4 must discontinue from the trial, but may be permitted to re-enroll at a later date once the inclusion/exclusion criteria have been met 6. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment and/or antibiotics in the 6 weeks prior to screening (Visit 2). In the event of an exacerbation occurring during the run-in period, the patient must discontinue from the study. The patient may re-enroll once the inclusion/exclusion criteria have been met 7. Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis 8. Patients with a history (at visit 1) of asthma, indicated by (but not limited to): a. Onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40 years PLEASE SEE PROTOCOL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate superiority of 150 &#956;g o.d. of indacaterol versus tiotropium 18 &#956;g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment. Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose.;Secondary Objective: To demonstrate that indacaterol 150 &#956;g o.d, is non inferior to tiotropium 18 &#956;g o.d. with regard to the rate of exacerbations during 52 weeks of treatment;Primary end point(s): To demonstrate superiority of 150 &#956;g o.d. of indacaterol versus tiotropium 18 &#956;g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose.
- Secondary Outcome Measures
Name Time Method