A 52-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- -J449 Chronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease, unspecifiedJ449
- Registration Number
- PER-040-10
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
• Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
• Patients with severe to very severe COPD (Stage III or IV) according to the (GOLD Guidelines, 2008).
• 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).
• Patients with a post-bronchodilator FEV1 < 50% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at Visit 2 (day -14).
• (Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol).
• A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics.
• Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
• 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
• 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 Visit 1 or between Visit 1 (Day -21) and Visit 3 (Day 1).
• Patients who develop a COPD exacerbation during a period between Visit 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.
• Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 (Day -21)
• Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
• Patients with lung lobectomy, or lung volume reduction or lung transplantation.
• Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.<br><br><br>Measure:Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period<br>Timepoints:64 weeks<br>
- Secondary Outcome Measures
Name Time Method