A Phase III, randomized, double-blind, placebo controlled, multicenter, 3-period, 14 day crossover study to determine the 24-h lung function profile of indacaterol (300 µg o.d.) in patients with moderate to- severe COPD, using open-label salmeterol (50 µg b.i.d.) as active control

• Conditions: moderate to severe chronic obstructive pulmonary disease (COPD).; MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2007-005468-28-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-03
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion 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, 2006) and:
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 (forced vital capacity) <70%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or nursingwomen
2. Women of child-bearing potential, UNLESS they meet the following definition of postmenopausal: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels or are using one or more of the following acceptable methods of contraception:
• surgical sterilization
• hormonal contraception
• double-barrier methods
3. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 2 or during the run-in period
4. Patients requiring long-term oxygen therapy for chronic hypoxemia
5. 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 3 must discontinue from the trial, but may be permitted to re-enroll at a later date
6. Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis
7. Patients with a history of asthma
8. 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 glycosylated hemoglobin >8.0% of total hemoglobin measured at Visit 2
9. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as unstable ischemic heart disease, arrhythmia, uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
10. Any patient with lung cancer or a history of lung cancer
11. Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.
12. Patients with a history of long QT syndrome or whose QTc interval measured at Visit 2 or Visit 3 is prolonged: >450 ms (males) or >470 ms (females) as assessed by the central ECG interpretation (Visit 2) or investigator’s interpretation of the pre dose ECGs (Visit 3). Patients who fail the screening ECG should not be re-screened
13. Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof
14. Patients who do not maintain regular day/night, waking/sleeping cycles
15. Patients who have had treatment with other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 2, whichever is longer
16. Patients who have been vaccinated with live attenuated vaccines within 30 days prior to Visit 2 or during the run-in period.
17. Treatments for COPD and allied conditions: the following medications must not be used prior to Visit 2 for at least the minimum washout period specified below or at any time during the study:
a) The long-acting anticholinergic agent tiotropium
b) Short-acting anticholinergics
c) Fixed combinations of ß2-agonists and inhaled corticosteroids
d) Fixed combinations of an anticholinergic and short-acting ß2-agonist
e) Long-acting ß2-agonists
f) Short-acting ß2-agonists
g) Theophylline and other xanthines
h) Parenteral or oral corticosteroids
18. The following medications should not be used unless they have been stabilized: a) Inhaled or nasal corticosteroids
b) Antih

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified