A multicenter, randomized, double-blind, placebocontrolledstudy, to assess the long term safety of 52weeks treatment with QVA149 (110µg indacaterol / 50µgglycopyrrolate) in patients with moderate to severe ChronicObstructive Pulmonary Disease (COPD)

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

• Registration Number: EUCTR2009-013235-38-LT
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following 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 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 post-bronchodilator FEV1 = 30% and <80% of the predicted normal, and
post-bronchodilator FEV1/FVC 0.7 at Visit 2
(Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of
ipratropium bromide and 400 µg of salbutamol or equivalent dose of albuterol)
5. Patients, according to daily electronic diary data between Visit 2 and Visit 3, with a
total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.
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

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine
pregnancy test).
2. Women of child-bearing potential (WOCBP), 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 post-menopausal: 12 months of natural (spontaneous) amenorrhea OR 6
weeks after surgical bilateral oophorectomy (with or without hysterectomy) OR are
using one or more of the following acceptable methods of contraception:
• surgical sterilization (e.g. bilateral tubal ligation),
• hormonal contraception (implantable, patch, oral, IM) and copper coated IUD, if
accepted by local regulatory authority and ethics committee,
• double barrier method (diaphragm plus condom),
• At the discretion of the investigator, total abstinence is acceptable in cases where
the age, career, lifestyle, or sexual orientation of the patient ensures compliance
• Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation
methods) and withdrawal are not acceptable methods of contraception.
Note: Reliable contraception should be maintained throughout the study.
3. Patients requiring long term oxygen therapy (> 15h a day) on a daily basis for chronic
hypoxemia.
4. Patients who have had a COPD exacerbation that required treatment with antibiotics or
oral steroids or hospitalization in the 6 weeks prior to Visit 1 or between Visit 1 and
Visit 3
5. Patients who develop a COPD exacerbation during the period between Visits 1 and 3
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
6. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
Patients who develop an upper or lower 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)
7. 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.
8. Patients with lung lobectomy, or lung volume reduction or lung transplantation.
9. 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, history of myocardial
infarction, arrhythmia (excluding chronic stable AF)
• 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
• Uncontrolled hypo- or hyperthyroidism, hypokalemia or hyperadrenergic state
• narrow-angle glaucoma
• symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to
severe renal impairment or urinary retention
• any condition which might compromise patient safety or compliance, interfere
with evaluation, or preclude completion of the study
10. Patients with any history of asthma indicated b

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety/tolerability of 52 weeks of treatment with QVA149 (110µg<br>indacaterol/50µg glycopyrrolate) once a day on adverse event reporting rate in patients<br>with moderate or severe Chronic Obstructive Pulmonary Disease (COPD);Secondary Objective: 1. To compare the safety of QVA149 with placebo over 52 weeks treatment based on vital<br>signs, ECGs, laboratory evaluations.<br>2. To compare the bronchodilator effect of QVA149 with placebo based on the mean FEV1<br>at 15 and 45 minutes pre-dose at week 52.;Primary end point(s): safety/tolerability of 52 weeks of treatment with QVA149 (110µg<br>indacaterol/50µg glycopyrrolate)