To evaluate the effect of QVA149 on patient reported dyspnea in moderate to severe chronic obstructive pulmonary disease (COPD), using tiotropium as an active control

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 234

Inclusion Criteria

- Male or female adults aged =40 years, who have signed an Informed Consent Form prior
to initiation of any study-related procedure.
- Patients with moderate to severe stable COPD (Stage II or Stage III) according to the GOLD Guidelines 2009.
- Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- Patients with a post-bronchodilator FEV1 =30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14).
- mMRC grade of at least 2 at Visit 2.
- Patients with ability to use the computer mouse and navigate the computer display.
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

- Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy
test).
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study. UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea, OR 6 weeks after surgical bilateral oophorectomy (with or without hysterectomy).
- 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.
- 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.
- Patients with Type I or uncontrolled Type II diabetes
- Patients who have not achieved spirometry result at Visit 2 in accordance with ATS/ERS criteria for acceptability and repeatability.
- Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
-Patients with a history of malignancy of any organ system
-Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic
hypoxemia.
-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 screening (Visit 1 or between Visit 1 and Visit 3).
-Patients who develop a COPD exacerbation between the pre-screening and the randomization visit (Visits 1 and 3) will not be eligible but will be permitted to be rescreened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
-Patients who have had a respiratory tract infection within 6 weeks prior to pre-screening

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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