Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-03-31

Brief Summary

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To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

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Detailed Description

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This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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15 mcg BID / 30 mcg QD

Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit.

Group Type EXPERIMENTAL

Arformoterol Tartrate Inhalation Solution

Intervention Type DRUG

Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)

Arformoterol Tartrate Inhalation Solution

Intervention Type DRUG

Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)

Placebo

Intervention Type DRUG

Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

30 mcg QD / 15 mcg BID

Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit.

Group Type EXPERIMENTAL

Arformoterol Tartrate Inhalation Solution

Intervention Type DRUG

Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)

Arformoterol Tartrate Inhalation Solution

Intervention Type DRUG

Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)

Placebo

Intervention Type DRUG

Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

Interventions

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Arformoterol Tartrate Inhalation Solution

Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)

Intervention Type DRUG

Arformoterol Tartrate Inhalation Solution

Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)

Intervention Type DRUG

Placebo

Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

Intervention Type DRUG

Other Intervention Names

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Brovana Brovana

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects must be at least 45 years old at the time of consent.
* Subjects must have a pre-established primary clinical diagnosis of COPD.
* Subjects must have a baseline FEV1 of ≤ 65% of predicted normal value at Visit 1.
* Subjects must have a FEV1 ≥ 0.70L at Visit 1.
* Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.

Exclusion Criteria

* Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Screening.
* Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No