Chronic Obstructive Pulmonary DiseasePhase 4ARFEETNCT00754546
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
A Phase 4 study testing Arformoterol tartrate, Treadmill Exercise and Cycle Exercise in people with Chronic Obstructive Pulmonary Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Arformoterol tartrate, Treadmill Exercise and Cycle Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of < 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.
Who cannot join
- any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
About this study
Official title: Effects of Arformoterol on Exercise Endurance Time and Breathlessness in COPD: Cycle Ergometer vs. Treadmill
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.
Read the detailed description
The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. At visits 2 and 3 patients will inhale 2 puffs of albuterol HFA MDI, and then perform symptom limited incremental exercise on the treadmill or cycle ergometer (randomized order); after a one hour rest, the patient will perform constant work exercise at 80-85% of peak VO2 on the same exercise mode.
At visits 4 - 7, patients will perform PFTs at baseline and at 30 and 120 minutes after inhaling arformoterol or normal saline (randomized order) and then constant work exercise on the treadmill or cycle ergometer (randomized order). Metabolic measurements will be made throughout exercise, and patients will provide continuous ratings of breathlessness and leg discomfort using a system consisting of a computer, monitor, and a mouse.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Arformoterol tartrate, Placebo: Normal Saline, Treadmill Exercise, Cycle Exercise
- Keywords
- exercise;, treadmill;, cycle ergometer;, breathlessness;, leg discomfort
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arformoterol tartrateDrug
Also called Brovana
15 mcg in two ml solution administered via nebulizer
Placebo: Normal SalineDrug
Normal saline was nebulized.
Treadmill ExerciseOther
Cycle ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Arformoterol tartrate | Active comparator | Bronchodilator therapy with arformoterol solution 15 mcg Receives: Drug: Arformoterol tartrate; Other: Treadmill Exercise; Other: Cycle Exercise |
| Normal saline | Placebo comparator | Placebo using normal saline Receives: Drug: Placebo: Normal Saline; Other: Treadmill Exercise; Other: Cycle Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Endurance Time
Participants were asked to exercise until symptom limitation
Measured: After one dose
Secondary outcomes (1)
Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise
linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise
The higher the number the worse the shortness of breath
Measured: After one dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Doanld A Mahler, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754546
- Sponsor's protocol ID
- 21261
- Acronym
- ARFEET
- Status last verified
- May 2013
- First submitted
- 16 Sep 2008
- Last updated
- 29 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zhang X, Waterman LA, Ward J, Baird JC, Mahler DA. Advantages of endurance treadmill walking compared with cycling to assess bronchodilator therapy. Chest. 2010 Jun;137(6):1354-61. doi: 10.1378/chest.09-2470. Epub 2009 Dec 29.
PubMed 20040610
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arformoterol on Exercise Endurance Time and Breathlessness in COPD: Cycle Ergometer vs. Treadmill
- ClinicalTrials.gov ID
- NCT00754546
- Acronym / sponsor ID
- ARFEET / 21261
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- exercise;, treadmill;, cycle ergometer;, breathlessness;, leg discomfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 29 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.
Detailed description
The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. At visits 2 and 3 patients will inhale 2 puffs of albuterol HFA MDI, and then perform symptom limited incremental exercise on the treadmill or cycle ergometer (randomized order); after a one hour rest, the patient will perform constant work exercise at 80-85% of peak VO2 on the same exercise mode.
At visits 4 - 7, patients will perform PFTs at baseline and at 30 and 120 minutes after inhaling arformoterol or normal saline (randomized order) and then constant work exercise on the treadmill or cycle ergometer (randomized order). Metabolic measurements will be made throughout exercise, and patients will provide continuous ratings of breathlessness and leg discomfort using a system consisting of a computer, monitor, and a mouse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arformoterol tartrate | Active comparator | Drug: Arformoterol tartrate, Other: Treadmill Exercise, Other: Cycle ExerciseBronchodilator therapy with arformoterol solution 15 mcg |
| Normal saline | Placebo comparator | Drug: Placebo: Normal Saline, Other: Treadmill Exercise, Other: Cycle ExercisePlacebo using normal saline |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of < 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.
Key exclusion criteria (1 listed)
- any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing
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 |
|---|---|---|
| Arformoterol tartrateAlso: Brovana15 mcg in two ml solution administered via nebulizer | Drug | Arformoterol tartrate |
| Placebo: Normal SalineNormal saline was nebulized. | Drug | Normal saline |
| Treadmill Exercise | Other | Arformoterol tartrate, Normal saline |
| Cycle Exercise | Other | Arformoterol tartrate, Normal saline |
Primary outcome
Exercise Endurance Time
Time frame: After one dose
Participants were asked to exercise until symptom limitation
1 secondary outcome
Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise
Time frame: After one dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20040610Zhang X, Waterman LA, Ward J, Baird JC, Mahler DA. Advantages of endurance treadmill walking compared with cycling to assess bronchodilator therapy. Chest. 2010 Jun;137(6):1354-61. doi: 10.1378/chest.09-2470. Epub 2009 Dec 29.
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Recruiting
Study on Impact of Maximal Strength Training in Patients With COPD
Chronic Obstructive Pulmonary Disease
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.
Doanld A Mahler, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 Arformoterol tartrate, Treadmill Exercise and Cycle Exercise in people with Chronic Obstructive Pulmonary Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 1 inclusion and 1 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 29 May 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Exercise Endurance Time (time frame: After one dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754546, which also lists 1 linked publication.
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 29 May 2013.