Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDChronic BronchitisChronic Emphysema

Outcome Measures

Primary Outcomes (1)

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 Outcomes (8)

Spirometry parameters
Days -21, -14, 0, 14, 28, and 42
Exacerbations of COPD
Days -14, 0, 14, 28, 42
COPD symptom ratings
Days 0, 14, 28, 42
Baseline dyspnea and transitional dyspnea indices
Days 0, 14, 28, 42
Ipatropium Bromide MDI use
Day 0, 14, 28, 42
+3 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

Levalbuterol 0.63 mg TID

Drug: Levalbuterol HCl

2

EXPERIMENTAL

Levalbuterol 1.25 mg TID

Drug: Levalbuterol HCl

3

ACTIVE COMPARATOR

Racemic Albuterol 2.5 mg TID

Drug: Albuterol Sulfate

Interventions

Levalbuterol HClDrug

Levalbuterol 0.63 TID

Also known as: Xopenex HCl Inhalation Solution

Levalbuterol HClDrug

Levabuterol 1.25 mg TID

Also known as: Xopenex HCl Inhalation Solution

Eligibility Criteria

Age35 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Sumitomo Pharma America, Inc.
Industrylead

Study Sites (24)

Carmichael, California, United States

Spring Valley, California, United States

Wheat Ridge, Colorado, United States

Largo, Florida, United States

Miami, Florida, United States

Panama City, Florida, United States

Atlanta, Georgia, United States

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Enrollment

257 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

February 2002

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations