A 26-week treatment, multi center, randomized, double blind, double dummy, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease, using salmeterol (50 µg b.i.d.) as an active control.
- Conditions
- chronic obstructive pulmonary diseaseMedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2007-002376-34-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 972
Male and female adults aged = 40 years, who have signed an Informed Consent .
Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2005) and including:
a) Smoking history of at least 20 pack years
b) Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value.
c) Post-bronchodilator FEV1/FVC < 70%
(Post refers to within 30 min after inhalation of 400 µg od salbutamol - equivalent to 4x90 µg albuterol delivered at the mouthpiece at Visit 1)
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
Pregnant or nursing (lactating) women, or women of child-bearing potential UNLESS post-menopausal or using acceptable methods of contraception.
Patients who have had a respiratory tract infection, or hospitalization for a COPD exacerbation, in the 6 weeks prior to Visit 1 or during the run-in period.
Patients requiring oxygen therapy for chronic hypoxemia (>15 h per day delivered by home oxygen cylinder or concentrator).
Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis.
Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited to): blood eosinophil count > 400/mm3 or onset of respiratory symptoms prior to age 40 years.
Patients with diabetes Type I or uncontrolled diabetes Type II.
Patients who have a clinically relevant laboratory abnormality or a clinically significant condition, or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
Any patient with lung cancer or a history of lung cancer; or any patient with active cancer or a history of cancer with less than 5 years disease free survival time on a case-by-case basis.
Patients with a history (or family history) of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 1 or Visit 3 is prolonged: > 450 ms (males) or > 470 ms (females).
Patients who do not maintain regular day/night, waking/sleeping cycles.
Patients who have had treatment with investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
Some treatments for COPD and allied conditions, or some non-COPD medications, within at the minimum washout period specified or at any time during the study.
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