A 26-week treatment, multi-center, randomized, double-blind, double dummy, parallel-group study to assess the efficacy, safety and tolerability of QVA149 compared to fluticasone/salmeterol in patients with moderate to severe chronic obstructive pulmonary disease

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 12.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease

• Registration Number: EUCTR2010-023621-37-LT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-18
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 522

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 (Stage II or Stage III) according to the GOLD Guidelines 2009.
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 < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14).
(Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
5. Symptomatic patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days.

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 (pregnancy confirmed by positive urine pregnancy test).
2. Women of child-bearing potential (WOCBP) except under certain circumstances (see protocol).
3. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
4. Patients with a history of long QT syndrome or whose QTc measured at Visit 2 (Day -14) (Fridericia method) is prolonged (>450 ms for males and females) as confirmed by the central ECG assessor.
5. Patients who have a clinically significant abnormality on the Visit 2 ECG who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients should not be re-screened).
6. Patients with Type I or uncontrolled Type II diabetes.
7. Patients who have not achieved an acceptable spirometry result at Visit 2 in accordance with ATS/ERS criteria for acceptability and repeatability
8. Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (Patients with a transurethral resection of prostate (TURP) are excluded from the study. Patients who have undergone full re-section of the prostate may be considered for the study, as well as patients who are asymptomatic and stable on pharmacological treatment for the condition).
9. Patients with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
10. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition
11. Patients unable to use an electronic patient diary.
12. Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
COPD specific exclusion
13. Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
14. Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
15. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1. Patients who develop an upper or lower respiratory tract infection during the screening period (up to Visit 3) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection.
16.Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
17. Patients with lung lobectomy, lung volume reduction, or lung transplantation.
18. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count >600/mm3 (at Visit 2) or onset of symptoms prior to 40 years. Patients without asthma but who have a blood eosinophil count >600/mm3 at Visit 2 are excluded
19. Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose is permitted).
20. Patients with eczema (atopic), known high IgE levels, or a known positive skin prick test in the last 5 years.
21. Patients with known history and diagn

Study & Design

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