Study to assess the efficacy and safety of QVA149 in patients with COPD

• Conditions: chronic obstructive pulmonary disease (COPD); MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-004870-26-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-07
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 2010.
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 =30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2.

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 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550

Exclusion Criteria

1.Women who are pregnant or breast feeding
2.Women of child-bearing potential must use effective contraception
3.Patients with conditions 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
•anticholinergics
•long and short acting beta-2 agonists
•sympathomimetic amines
•lactose or any of the other excipients
4.Patients with a history of long QT syndrome or whose QTc measured at Visit 2 is prolonged (>450 ms for males and females).
5.Patients who have a clinically significant abnormality on the ECG at Visit 2, 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 paroxysmal (e.g. intermittent) atrial fibrillation are excluded.
7.Patients with Type I or uncontrolled Type II diabetes including patients with a history of blood glucose levels consistently outside the normal range or HbA1c> 8.0% of a total Hb measured at screening (Visit 2).
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. Patients with non-melanoma skin carcinoma may be considered for the study.
10.Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
•unstable ischemic heart disease, left ventricular failure (NYHA Class III & IV), history of myocardial infarction, arrhythmia (excluding chronic stable AF). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study.
•uncontrolled hypo-or hyperthyroidism, hypokalemia or hyperadrenergic state
•any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
11.Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
12.Patients with a body mass index (BMI) of more than 40 kg/m2.
COPD specific exclusion
13.Patients requiring long term oxygen therapy (> 15 h a day) 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 6 weeks prior to pre-screening.
15.Patients who develop a COPD exacerbation between the pre-screening and the randomization visit will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
16.Patients who have had a respiratory tract infection within 6 weeks prior to pre-screening (Visit 1).
17.Patients who develop a respiratory tract infection between pre-screening and randomization (up to Visit 3)

Study & Design

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