A 12-week treatment, multi-center, randomized, parallel group, blinded, double dummy study to compare the efficacy and safety of Indacaterol (150 μg o.d.) delivered via a SDDPI with Tiotropium (18 μg o.d.) delivered via a HandiHaler, in patients with moderate-to-severe COPD. - ND
- Conditions
- moderate-to-severe COPD.MedDRA version: 9.1Level: PTClassification code 10029978
- Registration Number
- EUCTR2009-010665-23-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 1568
Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure 2. Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2007) and including: a. Smoking history of at least 10 pack years b. Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value (Visit 2). c. Post-bronchodilator FEV1/FVC < 70% (Visit 2). (Post refers to within 10-15 min of inhalation of 400 μg (4x100 μg) of salbutamol, equivalent to 4 x 90 μg albuterol delivered at the mouthpiece, at screening (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
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 follicle stimulating hormone 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: intrauterine device, 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, postovulation 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 with a body mass index (BMI) of more than 40 kg/m2 4. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening (Visit 2). In the event of an exacerbation occurring during the run-in period (Visits 2-4), the patient must discontinue from the study. The patient may be re-screened once the inclusion/exclusion criteria have been met 5. 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 6. 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 re-screened at a later date 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 (up to and including Visit 2) of asthma indicated by (but not limited to): a) onset of respiratory symptoms (such as cough, wheezing, shortness of breath) suggestive of asthma prior to age 40 years b) history of a diagnosis of asthma Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c > 8.0 % of total hemoglobin measured at Visit 2 9. Patients with contraindications for tiotropium treatment including medical history of symptomatic prostatic hypertrophy, bladder neck obstruction, narrow angle glaucoma and moderate to severe renal impairment (creatinine clearance ≤ 50 mL/min) 10. 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