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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

indacaterol

Intervention Type DRUG

delivered via single-dose dry-powder inhaler

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

delivered via single-dose dry-powder inhaler

Interventions

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indacaterol

delivered via single-dose dry-powder inhaler

Intervention Type DRUG

placebo

delivered via single-dose dry-powder inhaler

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No