A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 Î*g o.d. vs inhaled tiotropium 18 Î*g o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD
- Conditions
- Chronic Obstructive Pulmonary DiseaseCOPD10006436
- Registration Number
- NL-OMON38156
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1) male and female adults diagnosed with COPD aged 40 years and over
2) co-operative outpatients with a diagnoses of COPD (severe as calissified by the GOLD guidelines 2007 and including;
a) Smoking history of at least 10 pack years, both current and ex-smokers are eligible
b) Post bronchodilator FEV1<50% and >/ 30% of the predicted normal value
3) Post bronchodilator FEV1/FVC <70%
d) A documented history of at least 1 moderated or severe exacerbation in the previous 12 months (pg 14)
for a complete list please see protocol section 5.2
#. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment and/or antibiotics in the 6 weeks prior to screening (Visit 2).
#. Patients requiring oxygen therapy for chronic hypoxemia.
#. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2.
#. Patients with a history (up to and including Visit 2) of asthma indicated by (but not limited to):
a) onset of respiratory symptoms 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.
#. Patients with a history (or family history) of long QT syndrome or whose QTc interval (Fridericia) measured at Visit 2 is prolonged.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate superiority of 150 µg o.d. of indacaterol versus tiotropium 18<br /><br>µg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of<br /><br>treatment Trough is defined as the mean of FEV1 measurements at 23h 10 min and<br /><br>23h 45 min post morning dose</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key<br /><br>* To demonstrate that indacaterol 150 µg o.d. is non inferior to tiotropium 18<br /><br>µg o.d. with regard to the rate of exacerbations during 52 weeks of treatment<br /><br>(see Section 7.4.2 for definition of exacerbation)<br /><br><br /><br>See other on page 11</p><br>