NCT00525564

Brief Summary

This study was designed to test the following hypothesis: The acute changes in exercise tolerance during the endurance shuttle walk will be greater with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
Last Updated

September 6, 2007

Status Verified

September 1, 2007

First QC Date

September 4, 2007

Last Update Submit

September 5, 2007

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD)ExerciseEndurance shuttle walking testBronchodilationSalmeterol

Outcome Measures

Primary Outcomes (1)

  • Endurance time during an endurance shuttle walk

    acute response (2.5 hours) following the administration of the active and comparison drug

Secondary Outcomes (2)

  • Dyspnea during endurance shuttle walk

    acute response following the administration of the study medication

  • cardio-respiratory responses during an endurance shutlle walk

    acute response following the administration of the study medication

Study Arms (2)

A

PLACEBO COMPARATOR

Placebo diskus

Drug: Placebo

B

ACTIVE COMPARATOR

Salmeterol diskus powder

Drug: Salmeterol diskus inhalation powder

Interventions

PlaceboDRUG

Placebo diskus inhalation powder

A
Salmeterol diskus inhalation powderDRUG

50 micrograms twice a day

Also known as: Serevent
B

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 50 years
  • smoking history \> 10 packs/year
  • FEV1 \< 70% of predicted and FEV1/FVC \< 70%.

You may not qualify if:

  • respiratory exacerbation within the 2 months preceding the study
  • history of asthma
  • significant O2 desaturation (SaO2 \< 85%) at rest or during exercise
  • presence of another pathology that could influence exercise tolerance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • François Maltais, MD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 6, 2007

Study Start

May 1, 2006

Study Completion

October 1, 2006

Last Updated

September 6, 2007

Record last verified: 2007-09

Locations

CA(1)