Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Levalbuterol HCl; Drug: Albuterol Sulfate; Drug: Placebo

• Registration Number: NCT00665600
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.

Detailed Description

This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject. 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.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• Male and female subjects must be at least greater than or equal to 35 years of age at the time of consent.
• Subjects must have a pre-established primary clinical diagnosis of COPD.
• Subjects must have a baseline FEV1 less than or equal to 65%
• Subjects must have a predicted and >0.70 Liter
• subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
• Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70%
• Subjects must have a greater than or equal to 15 pack-year smoking history
• Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2
• Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry.
• No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry

Exclusion Criteria

• Females who are pregnant or lactating.
• Concurrent requirement of oxygen therapy
• Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
• Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
• Lung resection of more than one full lobe.
• Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry
• History of upper or lower respiratory infection within 14 days of study entry.
• Participation in an investigational drug study within 30 days of study entry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Levalbuterol HCl	Levalbuterol 1.25 mg TID
1	Levalbuterol HCl	Levalbuterol 0.63 mg TID
3	Albuterol Sulfate	Racemic Albuterol 2.5 mg TID
4	Placebo	Placebo TID

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period.	Days -21, -14, 0, 14, 28, and 42

Secondary Outcome Measures

Name	Time	Method
COPD symptom ratings	Days 0, 14, 28, 42
Subject and physician global evaluations	Days 14, 28, 42
Ipatropium Bromide MDI use	Day 0, 14, 28, 42
Short acting Beta-agonist MDI use	Days 0, 14, 28, 42
Spirometry parameters	Days -21, -14, 0, 14, 28, and 42
Exacerbations of COPD	Days -14, 0, 14, 28, 42
Baseline dyspnea and transitional dyspnea indices	Days 0, 14, 28, 42
St. George's Hospital Respiratory Questionnaire (SGRQ).	Days 0, 42