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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Withdrawn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

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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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