Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control (INITIATE)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Indacaterol
Placebo to tiotropium
Tiotropium
Placebo to indacaterol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Chronic obstructive pulmonary disease, indacaterol, tiotropium
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Indacaterol
Placebo
Tiotropium
Arm Description
Indacaterol once daily
Placebo for indacaterol and placebo for tiotropium once daily
Tiotropium
Outcomes
Primary Outcome Measures
Efficacy comparison of indacaterol to placebo
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
St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments
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
Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second.
St George's Respiratory Questionnaire for COPD total score comparison between treatments
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
All adverse events will be reported
Full Information
NCT ID
NCT01715311
First Posted
October 24, 2012
Last Updated
April 19, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01715311
Brief Title
Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control
Acronym
INITIATE
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
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Withdrawn
Why Stopped
withdrawn prior to patient recruitment
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Chronic obstructive pulmonary disease, indacaterol, tiotropium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indacaterol
Arm Type
Experimental
Arm Description
Indacaterol once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for indacaterol and placebo for tiotropium once daily
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Description
Tiotropium
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol once daily via single-dose dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Placebo to tiotropium
Intervention Description
Placebo to tiotropium capsules for inhalation once daily
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Other Intervention Name(s)
Tiotropium 18 mcg od via single-dose dry powder inhaler
Intervention Description
Tiotropium capsules for inhalation once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to indacaterol
Intervention Description
Placebo to indacaterol capsules for inhalation once daily
Primary Outcome Measure Information:
Title
Efficacy comparison of indacaterol to placebo
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments
Description
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.
Time Frame
12 weeks
Title
Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups
Description
Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second.
Time Frame
12 weeks
Title
St George's Respiratory Questionnaire for COPD total score comparison between treatments
Description
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.
Time Frame
12 weeks
Title
Adverse events and serious adverse events for all treatment groups
Description
All adverse events will be reported
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control
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