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

NCT01543828 | Completed Phase 4 Results

• 1 other identifier: CQAB149BUS01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

COPD

Keywords

COPD; Indacatarol; placebo; crossover; patient perception

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

indacaterol then placebo

EXPERIMENTAL

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

placebo then indacaterol

PLACEBO COMPARATOR

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

Interventions

indacaterol DRUG

delivered via single-dose dry-powder inhaler

indacaterol then placebo

placebo DRUG

delivered via single-dose dry-powder inhaler

placebo then indacaterol

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Fullerton, California, 92835, United States

Location

Novartis Investigative Site

Saint Charles, Missouri, 63301, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43213, United States

Location

Novartis Investigative Site

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 5, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 10, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-05

Locations

US (6)