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

NCT01715311 | Withdrawn Phase 4

• 2 other identifiers: CQAB149B24252012-001536-59
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Chronic obstructive pulmonary disease; indacaterol; tiotropium

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments

  12 weeks

• Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups

  12 weeks

• St George's Respiratory Questionnaire for COPD total score comparison between treatments

  12 weeks

• Adverse events and serious adverse events for all treatment groups

  week 12

Study Arms (3)

Indacaterol

EXPERIMENTAL

Indacaterol once daily

Drug: Indacaterol; Drug: Placebo to indacaterol

Placebo

PLACEBO COMPARATOR

Placebo for indacaterol and placebo for tiotropium once daily

Drug: Placebo to tiotropium; Drug: Placebo to indacaterol

Tiotropium

ACTIVE COMPARATOR

Tiotropium

Drug: Placebo to tiotropium; Drug: Tiotropium

Interventions

Indacaterol DRUG

Indacaterol once daily via single-dose dry powder inhaler

Indacaterol

Placebo to tiotropium DRUG

Placebo to tiotropium capsules for inhalation once daily

Placebo; Tiotropium

Tiotropium DRUG

Tiotropium capsules for inhalation once daily

Also known as: Tiotropium 18 mcg od via single-dose dry powder inhaler

Tiotropium

Placebo to indacaterol DRUG

Placebo to indacaterol capsules for inhalation once daily

Indacaterol; Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Tiotropium Bromide; Dry Powder Inhalers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 20, 2017

Record last verified: 2013-02