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Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01543828
First received: February 28, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in moderate-severe COPD patients with breathing symptoms to assess time to patient's perception of onset of effect.


Condition Intervention Phase
COPD
 Drug: indacaterol
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IV, Randomized, Double-blind, Placebo-controlled, Multicenter, Exploratory, Single-dose Crossover Study With Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

Drug Information available for: Indacaterol
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time (in Minutes) to Patient's Perception of Onset of Effect [ Time Frame: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2 ] [ Designated as safety issue: No ]

    Defined as the first time point that the patient responds "yes" to the following self-administered question:

    "I feel that the drug is working in improving my breathing?"



Enrollment: 40
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: indacaterol then placebo
In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
 Drug: indacaterol
delivered via single-dose dry-powder inhaler
Placebo Comparator: placebo then indacaterol
In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
 Drug: placebo
delivered via single-dose dry-powder inhaler

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:

    • Smoking history of at least 10 pack-years
    • Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 70% and ≥ 40% of the predicted normal value
    • Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
    • Breathing symptoms that interfere with daily activities

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients who require oxygen therapy for chronic hypoxemia, are receiving bronchodilators or other medications for COPD that are dosed once daily, are unable to follow instruction on rescue albuterol use during the study, or are at risk deterioration of COPD with study procedures. Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with uncontrolled diabetes mellitus
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular co-morbid conditions

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543828

Locations
United States, California
Novartis Investigative Site
Fullerton, California, United States, 92835
United States, Missouri
Novartis Investigative Site
St. Charles, Missouri, United States, 63301
United States, North Carolina
Novartis Investigative Site
Charlotte, North Carolina, United States, 28207
Novartis Investigative Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Novartis Investigative Site
Columbus, Ohio, United States, 43213
United States, Washington
Novartis Investigative Site
Tacoma, Washington, United States, 98405
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: NCT01543828     History of Changes
Other Study ID Numbers: CQAB149BUS01
Study First Received: February 28, 2012
Results First Received: March 19, 2013
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
COPD
Indacatarol
placebo
crossover
patient perception

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013