Chronic Obstructive Pulmonary DiseasePhase 4NCT00525564
Effects of Salmeterol on Walking Capacity in Patients With COPD
A Phase 4 study testing Salmeterol diskus inhalation powder in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Salmeterol diskus inhalation powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 50 years
- smoking history > 10 packs/year
- FEV1 < 70% of predicted and FEV1/FVC < 70%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background: Little is known about the responsiveness of the endurance shuttle walking test (ESWT) to pharmacotherapy in patients with chronic obstructive pulmonary disease (COPD). This exercise testing modality needs to be further investigated because of its relevance for activity of daily living.
Objective: To evaluate, in patients with COPD, the responsiveness of the ESWT to detect improvement in walking performance after single dose of salmeterol.
Methods: In a randomised, double-blind, placebo-controlled, crossover study, 20 patients with COPD will perform, on two separate days, an ESWT at 80% of peak capacity, 2 hours after inhaling either a placebo or 50µg of salmeterol. Cardiorespiratory parameters will be monitored breath-by-breath during each walking test with a portable telemetric gas analyzer (Oxycom Mobile, Jaeger, Germany). Inspiratory capacities and Borg ratings for dyspnea were obtained every other minute throughout the tests.
Planned analysis. The main outcome will be endurance time. This variable will be compared between the two treatment arms using a paired t test. The time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Placebo, Salmeterol diskus inhalation powder
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Exercise, Endurance shuttle walking test, Bronchodilation, Salmeterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo diskus inhalation powder
Salmeterol diskus inhalation powderDrug
Also called Serevent
50 micrograms twice a day
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo diskus Receives: Drug: Placebo |
| B | Active comparator | Salmeterol diskus powder Receives: Drug: Salmeterol diskus inhalation powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time during an endurance shuttle walk
Measured: acute response (2.5 hours) following the administration of the active and comparison drug
Secondary outcomes (2)
Dyspnea during endurance shuttle walk
Measured: acute response following the administration of the study medication
cardio-respiratory responses during an endurance shutlle walk
Measured: acute response following the administration of the study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startMay 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- François Maltais, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525564
- Sponsor's protocol ID
- SMS106875
- Status last verified
- Sep 2007
- First submitted
- 4 Sep 2007
- Last updated
- 6 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Salmeterol on Walking Capacity in Patients With COPD
- ClinicalTrials.gov ID
- NCT00525564
- Acronym / sponsor ID
- SMS106875
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Exercise, Endurance shuttle walking test, Bronchodilation, Salmeterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Little is known about the responsiveness of the endurance shuttle walking test (ESWT) to pharmacotherapy in patients with chronic obstructive pulmonary disease (COPD). This exercise testing modality needs to be further investigated because of its relevance for activity of daily living.
Objective: To evaluate, in patients with COPD, the responsiveness of the ESWT to detect improvement in walking performance after single dose of salmeterol.
Methods: In a randomised, double-blind, placebo-controlled, crossover study, 20 patients with COPD will perform, on two separate days, an ESWT at 80% of peak capacity, 2 hours after inhaling either a placebo or 50µg of salmeterol. Cardiorespiratory parameters will be monitored breath-by-breath during each walking test with a portable telemetric gas analyzer (Oxycom Mobile, Jaeger, Germany). Inspiratory capacities and Borg ratings for dyspnea were obtained every other minute throughout the tests.
Planned analysis. The main outcome will be endurance time. This variable will be compared between the two treatment arms using a paired t test. The time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboPlacebo diskus |
| B | Active comparator | Drug: Salmeterol diskus inhalation powderSalmeterol diskus powder |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 50 years
- smoking history > 10 packs/year
- FEV1 < 70% of predicted and FEV1/FVC < 70%.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo diskus inhalation powder | Drug | A |
| Salmeterol diskus inhalation powderAlso: Serevent50 micrograms twice a day | Drug | B |
Primary outcome
Endurance time during an endurance shuttle walk
Time frame: acute response (2.5 hours) following the administration of the active and comparison drug
2 secondary outcomes
Dyspnea during endurance shuttle walk
Time frame: acute response following the administration of the study medication
cardio-respiratory responses during an endurance shutlle walk
Time frame: acute response following the administration of the study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Maltais, MD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salmeterol diskus inhalation powder in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time during an endurance shuttle walk (time frame: acute response (2.5 hours) following the administration of the active and comparison drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2007.