Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Registration Number
- NCT01715311
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).
- Detailed Description
The purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD 2011 Groups A and B.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD 2011.
- Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and <80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7
- Patients with no record of receipt of maintenance medication for COPD.
- Patients with a mMRC dyspnea score ≥1 at Visit 2.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
- Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit 1.
- Patients who have had a respiratory tract infection.
- Patients requiring long-term oxygen therapy (>12 hours a day) on a daily basis.
- Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years.
- Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids intermittently. Treatment with a stable dose is permitted.
- Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis
- Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indacaterol Placebo to indacaterol Indacaterol once daily Tiotropium Placebo to tiotropium Tiotropium Placebo Placebo to tiotropium Placebo for indacaterol and placebo for tiotropium once daily Placebo Placebo to indacaterol Placebo for indacaterol and placebo for tiotropium once daily Indacaterol Indacaterol Indacaterol once daily Tiotropium Tiotropium Tiotropium
- Primary Outcome Measures
Name Time Method Efficacy comparison of indacaterol to placebo 12 weeks Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment.
- Secondary Outcome Measures
Name Time Method St George's Respiratory Questionnaire for COPD total score comparison between treatments 12 weeks Effects comparison of indacaterol to tiotropium in terms of St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.
Adverse events and serious adverse events for all treatment groups week 12 All adverse events will be reported
St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments 12 weeks Effects comparison of indacaterol to placebo in terms of the patient-centric measurement St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.
Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups 12 weeks Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second.