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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543828
• Other study ID #: CQAB149BUS01
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2012
• Last updated: May 6, 2013
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• indacaterol
delivered via single-dose dry-powder inhaler
• placebo
delivered via single-dose dry-powder inhaler

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	St. Charles	Missouri
United States	Novartis Investigative Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in Minutes) to Patient's Perception of Onset of Effect	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?"	5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2	No