A phase IIIb randomized, double-blind, placebo controlled, 2 period crossover, multicenter study to assess the effect of indacaterol (150 µg o.d.) on exercise endurance in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 96

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, 2007), Appendix 3 and additionally including:
a. Smoking history of at least 10 pack years.
b. Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value at screening.
c. Post-bronchodilator FEV1/FVC < 70% at screening.
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

Exclusion Criteria

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum
2. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, including women whose career, lifestyle, or sexual orientation
precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of postmenopausal:
12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous
amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of the
following acceptable methods of contraception:
- surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
- hormonal contraception (implantable, patch, oral)
- double-barrier methods (any double combination of: IUD, male or female condom
with spermicidal gel, diaphragm, sponge, cervical cap).
3. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid
treatment and/or antibiotics and/or hospitalization in the 6 weeks prior to screening (Visit 2). In the event of an exacerbation occurring during the run-in period, the patient must discontinue from the study. The patient may re-enroll once the inclusion/exclusion criteria have been met.
4. Patients whose body mass index is less than 15 or greater than 40 kg/m2.
5. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD
exacerbation). This is typically patients requiring oxygen therapy more than 15 h per day delivered by home oxygen cylinder or concentrator.
6. Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at Visit 2
7. Patients who have had a respiratory tract infection within 6 weeks prior to screening (Visit 2). Patients who develop a respiratory tract infection between prescreening (Visit 1) and randomization (Visit 3) must discontinue from the trial, but may be permitted to re-enroll at a later date once inclusion/exclusion criteria have been met (at least 6 weeks after the start of the respiratory tract infection)
8. Patients with contra-indications of cardiopulmonary exercise testing as described in the protocol.
9. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
10. Patients with a history of asthma indicated by (but not limited to):
- onset of respiratory symptoms suggestive of asthma prior to age 40 years
- a history of a diagnosis of asthma
11. Patients with Type I diabetes or uncontrolled Type II diabetes including patients with a history of blood glucose levels consistently outside the normal range or HbA1C > 8.0% of total Hb measured at screening (Visit 2)
12. 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 (but not limited to) those described in the protocol.
13. Any patient with lung cancer or a history of lung cancer
14. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
15. Patients with a history (or family history) of long QT syndrome or whose QTc interval (Fridericia’s) measured at screening (Visit 2) is prolonged: > 450 ms (males) o

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

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