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

February 28, 2012
May 6, 2013
January 2012
March 2012   (final data collection date for primary outcome measure)
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?"

Time (in minutes) to patient's perception of onset of effect [ Time Frame: 1 hour ] [ 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?"

Complete list of historical versions of study NCT01543828 on ClinicalTrials.gov Archive Site
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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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
COPD
  • Drug: indacaterol
    delivered via single-dose dry-powder inhaler
  • Drug: placebo
    delivered via single-dose dry-powder inhaler
  • 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.
    Intervention: Drug: indacaterol
  • 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.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
March 2012   (final data collection date for primary outcome measure)

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.

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01543828
CQAB149BUS01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP