Text Size

Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control (INITIATE)

This study has been withdrawn prior to enrollment.
(withdrawn prior to patient recruitment)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01715311
First received: October 24, 2012
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: Indacaterol
Drug: Placebo to tiotropium
Drug: Tiotropium
Drug: Placebo to indacaterol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy comparison of indacaterol to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
    All adverse events will be reported


Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol
Indacaterol once daily
 Drug: Indacaterol
Indacaterol once daily via single-dose dry powder inhaler
Drug: Placebo to indacaterol
Placebo to indacaterol capsules for inhalation once daily
Placebo Comparator: Placebo
Placebo for indacaterol and placebo for tiotropium once daily
 Drug: Placebo to tiotropium
Placebo to tiotropium capsules for inhalation once daily
Drug: Placebo to indacaterol
Placebo to indacaterol capsules for inhalation once daily
Active Comparator: Tiotropium
Tiotropium
 Drug: Placebo to tiotropium
Placebo to tiotropium capsules for inhalation once daily
Drug: Tiotropium
Tiotropium capsules for inhalation once daily
Other Name: Tiotropium 18 mcg od via single-dose dry powder inhaler

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715311

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01715311     History of Changes
Other Study ID Numbers: CQAB149B2425, 2012-001536-59
Study First Received: October 24, 2012
Last Updated: February 5, 2013
Health Authority: Australia: Department of Therapeutic Goods Administration
India: Drugs Controller General of India
Korea: Food and Drug Administration
Philippines: Bureau of Food and Drugs
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: Ministry of Health

Keywords provided by Novartis:
COPD
Chronic obstructive pulmonary disease
indacaterol
tiotropium

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013