Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS (GLOW8)

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Moderate to severe airflow limitation, GOLD spirometric classification 2 and 3, GOLD group B and D, NVA237, Salmeterol fluticasone propionate Read More

Inclusion Criteria:

• Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
• COPD (Chronic Obstructive Pulmonary Disease) patients with moderate to severe airflow limitation (Spirometry classification: GOLD 2 or 3) at Visit 2:
• Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) ≥30% and <60% of the predicted normal, and,
• Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70
• Patients on maintenance treatment with fixed-dose combination of inhaled salmeterol and fluticasone propionate (50/500 µg) b.i.d. delivered via a proprietary MDDPI (multidose dry powder inhaler) device for at least 30 days prior to screening visit (Visit 1).
• Patients in category Gold B or D with a CAT (COPD Assessment Test) total score ≥10 at screening (Visit 1) and before randomization (Visit 3).
• Patients with a history of at least 1 moderate or severe COPD exacerbation within the previous year.

Exclusion Criteria:

• Pregnant or nursing (lactating) women
• Women of child-bearing potential, unless they are using effective methods of contraception during the study
• Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms). (These patients cannot be re-screened.)
• Patients with evidence (upon visual inspection) of oropharyngeal candidiasis at baseline with or without treatment.
• Patients who have not achieved an acceptable spirometry result at run-in (Visit 2) in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability and repeatability.
• Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening (Visit 1).
• Patients who have had a respiratory tract infection within 4 weeks prior to screening (Visit 1).
• Patients requiring long term oxygen therapy prescribed for >12 hours per day.
• Patients with allergic rhinitis who use an H1 antagonist or intra-nasal corticosteroids intermittently. (Treatment with a stable dose or regimen is permitted.)
• Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension), clinically significant bronchiectasis, or history of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
• Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active.

Other protocol-defined inclusion/exclusion criteria may apply.