None listed
Conditions
Interventions
Group 1 Type of group
QVA149 110/50 μ
Open-label tiotropium bromide 18 μ
g capsules for inhalation once daily delivered via HandiHaler® device for at least 52 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
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 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period Timepoints:64 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Measure:Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period Timepoints:76 weeks ; 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. Measure:Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period Timepoints:64 weeks ; Outcome name:Rate of moderate or severe exacerbations per year = total number of moderate or se | — |
Countries
Austria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungaria, Ireland, Italy, Netherlands, Peru, Poland, Spain, United Kindgdom
Contacts
Public ContactPamela Olaechea
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed