Clinical trial NCT01715311: Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control
Official title: A Randomized, Double-blind Placebo-controlled Study to Compare the Efficacy of Indacaterol With That of Placebo in Patients With COPD Who Have Not Previously Received Maintenance COPD Medication, Using Blinded Tiotropium as Active Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Chronic obstructive pulmonary disease
indacaterol
tiotropium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Efficacy comparison of indacaterol to placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments
timeFrame: 12 weeks
measure: Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups
timeFrame: 12 weeks
measure: St George's Respiratory Questionnaire for COPD total score comparison between treatments
timeFrame: 12 weeks
measure: Adverse events and serious adverse events for all treatment groups
timeFrame: week 12
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: