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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665600
• Other study ID #: 051-914
• Status: Completed
• Phase: Phase 3
• Start date: February 2002
• Est. completion date: March 2003

Study information

• Verified date: June 2023
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Levalbuterol HCl
Levalbuterol 0.63 TID
• Levalbuterol HCl
Levabuterol 1.25 mg TID
• Albuterol Sulfate
Racemic albuterol 2.5 mg TID
• Placebo
Placebo TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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