A 52-week treatment, multicenter, randomized, doubleblind, double dummy, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (300 & 600 µg o.d.) in patients with chronic obstructive pulmonary disease, using formoterol (12 µg b.i.d.) as an active control

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease
COPD
10006436

Registration Number: NL-OMON30259

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 96

Inclusion Criteria

1. Male and female adults aged >= 40 years
2. Outpatients with a diagnosis of COPD according to the GOLD Guidelines (2005) and:
a) Smoking history of at least 20 pack years
b) Pre-bronchodilator FEV1 < 65% of the predicted normal value and at least 0.75 L.
c) Pre-bronchodilator FEV1/FVC < 70%

Exclusion Criteria

1. Pregnant or nursing (lactating) women
2. Women of child-bearing potential unless they are postmenopausal, had surgical sterilization, use hormonal contraception or double-barrier methods
3. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
4. Patients requiring long term (> 6 months) oxygen therapy for chronic hypoxemia
5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.
6. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis
7. Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited to):
a) Blood eosinophil count > 400/mm3
b) Onset of respiratory symptoms prior to age 40 years
8. Patients with diabetes Type I or uncontrolled diabetes Type II i(HbA1c > 8.0% of total Hb measured at Visit 1)
9. Any patient with lung cancer or a history of lung cancer
10. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time. Localized basal cell carcinoma (without metastases) of the skin is acceptable.
11. Patients with a history of long QT syndrome or whose QTc interval (Bazett*s) is
prolonged to > 450 ms (males) or > 470 ms (females)
12. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 or during the run-in period. (Inactivated influenza vaccination, pneumococcal vaccination or any other inactivated vaccine is acceptable provided it is not administered within 48 h prior to Visits 1, 2 or 3)
13. Treatments for COPD and allied conditions: the following medications must not be used prior to Visit 1 for at least the minimum washout period specified below or at any time during the study:
a) The long acting anti-cholinergic agent tiotropium: 7 days
b) Short acting anti-cholinergics: 8 h
c) Fixed combinations of β2-agonists and inhaled corticosteroids: 48 h
(Patients taking fixed dose combination therapy must be switched to the equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy)
d) Fixed combinations of β2-agonists and inhaled anticholinergics: 48 h
e) Long-acting β2-agonists: 48 h
f) Short acting β2-agonists (other than those prescribed in the study): 6 h
g) Theophylline and other xanthines: 1 week
h) Parenteral or oral corticosteroids: 1 month
14. Treatments for COPD and allied conditions: The following medications should not be used unless they have been stabilized:
a) Cromoglycate, nedocromil, ketotifen, omalizumab, inhaled or nasal corticosteroids and leukotriene antagonists - at least one month prior to Visit 1
b) Antihistamines (excluding those in 19c below) - at least 5 days prior to Visit 1
15. Other excluded medications:
a) Non-potassium sparing diuretics (unless administered as a fixed dose combination with a potassium conserving drug)
b) Non-selective beta-blocking agents
c) Cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide, quinidine), Class III (e.g., amiodarone, dofetilide, ibutilide, sotalol), terfenadine, astemizole, mizolastin and any drug with potential to significantly prolong the QT interval
d) Tricyclic antidepressants and monoamino-oxidase inhibitors.
16. Patients unable to successfully use

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>24 hrs post dose FEV1 after 12 weeks </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and tolerability: vital signs, ECG, laboratory results, adverse events<br /><br>and co-medication/significant non-medical therapies.<br /><br>Efficacy: Spirometry (FEV1), questionnaires, walking test, diary data<br /><br>Pharmacokinetic data.</p><br>