A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label tiotropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease.

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease
COPD
10006436

Registration Number: NL-OMON33827

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

1. Male and female adults aged 40 years and over
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, both current and ex-smokers are eligible
b) Post-bronchodilator FEV1 * 65% and * 30% of the predicted normal value
c) Post-bronchodilator FEV1/FVC < 70%

Exclusion Criteria

For a complete list please see protocol section 5.2.
#. 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).
#. 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>Standardized area under the curve (AUC) between 5 min and 8 h post-dose for<br /><br>forced expiratory volume in 1 second (FEV1) after 12 weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p># Efficacy<br /><br><br /><br>Key: 24 hour post-dose trough FEV1 after 12 weeks of treatment. The 24 h<br /><br>post-dose trough FEV1 is defined as the avarage of FEV1 measurements at 23 h 10<br /><br>min and 23 h 45 min post-dose.<br /><br><br /><br>Other: Standardized AUC 5min-8h FEV1 on Day 1, Standardized AUC 5min-4h FEV1 on<br /><br>Day 1 and after 12 weeks treatment,<br /><br>Trough FEV1 on Day 2, FEV1 and FVC at individual time points, Peak FEV1 during<br /><br>4 h post dose, Inspiratory Capacity, Symptom scores over 12 weeks, Daily Rescue<br /><br>Medication use (number of puffs) over 12 weeks, Daily rescue medication use<br /><br>(number of puffs) at 4 weekly intervals, Percentage of days with no rescue<br /><br>use over 12 weeks.<br /><br><br /><br><br /><br># Safety<br /><br><br /><br>Adverse events, ECG and vital signs, laboratory data</p><br>