A multi-center, randomized, double-blind, placebo- controlled, two-period cross-over study to assess the effect of 50µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD - n/a

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 13.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2010-018597-20-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2. Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD Guidelines 2008).
3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
4. Patients with a post-bronchodilator FEV1 =40% and < 70% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 during screening.
(Post refers to the highest post-bronchodilator value after inhalation of 80 µg ipratropium bromide).
5. Increase in FEV1 from Pre-bronchodilator to Post-bronchodilator assessment of at least 5%
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 women or nursing mothers.
2. Women of child-bearing potential (WOCBP), as defined by the protocol OR surgical bilateral oophorectomy with or without hysterectomy at least 6 months prior to screening Visit 1 OR are using one or more of the acceptable methods of contraception defined in the protocol.
3. Patients who have had a COPD exacerbation (whether hospitalized or not) in the 6 weeks
prior to Visit 1 or between Visit 1 and Visit 4.
4. Patients who have had a lower respiratory tract infection in the 6 weeks prior to Visit 1.Patients who develop a lower respiratory tract infection during the screening period (up to Visit 4) will not be eligible, but will be permitted to be re-screened at least 6 weeks after the resolution of the lower respiratory tract infection.
5. Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
6. Patients with resting (5 min) oxygen SaO2 saturation on room air of < 85%
7. Patients with a Wmax value <20 W (as determined by the incremental cycle endurance
test) at Visit 2.
8. Patients, whose exercise endurance time at sub-maximal workload is above 25 min at baseline
9. Patients with contraindications (acc. to ATS/ACCP Statement on cardiopulmonary exercise testing issued 2003) to cardiopulmonary exercise testing including (but not limited to) those defined in the protocol.
10. Patients involved in active phase of a supervised Pulmonary Rehabilitation Program.
11. Patients who have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) those defined in the protocol.
12. Patients with known history & diagnosis of alpha-1 antitrypsin deficiency.
13. Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
14. Patients with any history of asthma (as diagnosed by GINA guidelines).
15. Patients with allergic rhinitis who use H1 antagonists or intranasal corticosteroids intermittently are to be excluded. Treatment with a stable dose is permitted (constant dose for at least 5 days prior to visit 2 & 1mth prior to visit 2 respectively).
16. Patients with history of long QT syndrome or whose QTc is prolonged (>450 ms for males and (>470 ms females) at screening.
17. Patients who have clinically significant abnormality on the screening or baseline ECG.
18. Patients contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the inhaled drugs, drugs of a similar class or any component thereof listed in the protocol.
19. Treatments for COPD & allied conditions: the listed medications in the protocol should not be used between Visit 1 and Visit 4 and then through the subsequent course of the study.
20. Patients who need the treatments for COPD and allied conditions (e.g. allergic rhinitis) as listed in the protocol unless they have been stabilized as defined in the protocol.
21. Other excluded medications as defined in the protocol.
22. Patients unable to use a dry powder inhaler (SDDPI) device or pressurized MDI (rescue medication).
23. Patients unable to use an electronic patient diary.
24. Patients who are, in the opinion of the investigator known to be unreliable or noncompliant, or with any condition or prior or present treatment rendering the patient not eligible for the study.
25. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-li

Study & Design

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