Advanced CancersPhase 2/3NCT02597478
Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
A Phase 2/3 study testing Fentanyl Sublingual Spray, Shuttle Walk Test and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Fentanyl Sublingual Spray, Shuttle Walk Test and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2016to 27 Jan 2021
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer with evidence of active disease
- Breakthrough dyspnea, defined as dyspnea with an average intensity level over the past 7 days of at least 3/10 on a numeric rating scale upon significant exertion or continuous dyspnea </=7/10 with worsening upon significant exertion
- Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology, Cancer Pain Clinic, or Cardiopulmonary clinic
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 80-500 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- Karnofsky performance status >/=50%
- Age 18 or older
- Able to complete study assessments
Who cannot join
- Dyspnea at rest >/=7/10 at the time of enrollment
- Supplemental oxygen requirement >6 L per minute
- Delirium (i.e. Memorial delirium rating scale >13)
- History of unstable angina or myocardial infarction 1 month prior to study enrollment
- Resting heart rate >120 at the time of study enrollment
- Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment
Show all 12Show fewer
- History of active opioid abuse within the past 12 months
- History of allergy to fentanyl
- Severe anemia (Hb <7g/L) if documented in the last month and not corrected prior to study enrollment*
- Diagnosis of acute pulmonary embolism within past 2 weeks
- Diagnosis of pulmonary hypertension
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Preliminary Study of Prophylactic Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.
Read the detailed description
If you agree to take part in this study, the study staff will collect information from your medical record about your age, sex, race, and disease type, as well as how well you are able to perform the normal activities of daily living, any drugs you are taking, and any possible causes of shortness of breath.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to receive either low-dose or high-dose fentanyl spray. This is done because no one knows if one study group is better, the same, or worse than the other group.
Study Visit:
During your study visit, you will complete 2 questionnaires about any breathing problems or other symptoms you may be having. It should take about 10 minutes total to complete these questionnaires.
You will blow into a device called a spirometer a few times to measure your lung function. You will also be asked to inhale into another device called a negative inspiratory force meter (NIF). This device measures the volume of air that can be inhaled after normal breathing.
The study staff will then record your vital signs (heart rate, breathing rate, blood pressure, and your blood-oxygen level). Your blood-oxygen level will be measured with a device that will be clipped gently onto your fingertip). You will then be asked how hard it is to catch your breath and to rate your level of tiredness.
When instructed, you will walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. This is called the Shuttle Walk Test. The purpose of this timed test is to see how far and fast you can walk without stopping for a rest. You will be asked to pivot briskly around the cones and continue back the other way. You may stop this test at any time if you feel you cannot continue.
After that, you will sit down and rest for up to 1 hour. During this time, the study drug will be prepared, and you may be asked at different times how hard it is to catch your breath.
After the rest period, you will be given the fentanyl to spray into your mouth and under your tongue. About 10 minutes later, you will be asked about any side effects you may be having.
At that point, you will perform a second Shuttle Walk Test. Then the study staff will ask you again about any side effects you may be having, your level of tiredness, and how hard it is to catch your breath. Your vital signs will also be measured. The total distance you walked will also be recorded.
After each walk test, you will also be asked to complete 4 tests of your mental abilities, including finger tapping, simple math questions (addition, subtraction, multiplication, division), recall of numbers, and recall of objects. It should take 15 minutes total to complete these tests.
At the end of the study visit, you will be asked which dose level of the study drug you think you received (high-dose or low-dose). You will also complete a questionnaire about how the study drug may have helped you and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.
At the end of the study, if you think that taking fentanyl helped to improve your breathing, your doctor will be told, so that you and your doctor may discuss if fentanyl would be helpful to you in the future.
Length of Study:
Your active participation in this study is over after you complete the last questionnaire. You will be taken off study if intolerable side effects occur or if you are unable to follow study directions.
Follow-Up:
Fourteen (14) days after your study visit you will be called by the study staff and asked how you are feeling and about any side effects you may be having. This call should last about 10 minutes.
This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. Its use to control shortness of breath is investigational.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Fentanyl Sublingual Spray, Shuttle Walk Test, Questionnaires, Mental Ability Tests, Phone Call
- Keywords
- Advanced Cancers, Fentanyl Sublingual Spray, Fentanyl SL Spray, FSS, Questionnaires, Surveys, Mental Abilities Test, Phone Call, Shuttle Walk Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Sublingual SprayDrug
Also called Fentanyl SL Spray, FSS
Low-dose Fentanyl Goup: 15-25% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
High-Dose Fentanyl Group: 35-45% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
Shuttle Walk TestProcedure or surgery
Participants walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. After one hour Fentanyl Spray delivered, then second walk test performed.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completed about any breathing problems or other symptoms participant may be having at baseline. End of study questionnaire asks which dose level of study drug participant thinks they received. Participant also completes a questionnaire about how study drug may have helped them and how satisfied they are with the study. It should take about 5 minutes to complete the questionnaire.
Mental Ability TestsBehavioural
After each walk test, participant completes 4 tests of their mental abilities. It should take 15 minutes total to complete these tests.
Phone CallBehavioural
Thirty days study visit participant called by study staff. This call should last about 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Fentanyl Spray Group | Experimental | Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test. Receives: Drug: Fentanyl Sublingual Spray; Procedure: Shuttle Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests; Behavioral: Phone Call |
| High-Dose Fentanyl Spray Group | Experimental | Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test. Receives: Drug: Fentanyl Sublingual Spray; Procedure: Shuttle Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests; Behavioral: Phone Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Dyspnea Borg Scale (Dyspnea Intensity)
The primary outcome was dyspnea intensity "now" using the modified Borg scale, which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. This scale has been validated in multiple studies, with a minimal clinically significant difference of 1 point.
Measured: Before and after the first and second shuttle walk tests
Secondary outcomes (4)
Modified Dyspnea Borg Scale (Dyspnea Unpleasantness)
The modified Borg scale (dyspnea unpleasantness), which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests.
Measured: Before and after the first and second shuttle walk tests
Walk Distance
We measured the difference in walk distance (in meters) between the first and second shuttle walk tests.
Measured: After the first shuttle walk test and after the second shuttle walk test
Walk Time
We measured the difference in walk time (in minutes) between the first and second shuttle walk tests.
Measured: After the first shuttle walk test and after the second shuttle walk test
Fatigue Modified Borg Score
The fatigue modified Borg scale, which ranges from 0 ("none") to 10 ("worst"). We measured the change in modified fatigue Borg scale (0-10) between the first and second shuttle walk tests.
Measured: Before and after the first and second shuttle walk tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start4 Jan 2016
- Primary completion27 Sep 2018
- Study completion27 Jan 2021
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.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- INSYS Therapeutics Inc
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597478
- Sponsor's protocol ID
- 2015-0137
- Other IDs
- NCI-2015-02132
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2015
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Prophylactic Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
- ClinicalTrials.gov ID
- NCT02597478
- Acronym / sponsor ID
- 2015-0137
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Fentanyl Sublingual Spray, Fentanyl SL Spray, FSS, Questionnaires, Surveys, Mental Abilities Test, Phone Call
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- INSYS Therapeutics Inc
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 8 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.
Detailed description
If you agree to take part in this study, the study staff will collect information from your medical record about your age, sex, race, and disease type, as well as how well you are able to perform the normal activities of daily living, any drugs you are taking, and any possible causes of shortness of breath.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to receive either low-dose or high-dose fentanyl spray. This is done because no one knows if one study group is better, the same, or worse than the other group.
Study Visit:
During your study visit, you will complete 2 questionnaires about any breathing problems or other symptoms you may be having. It should take about 10 minutes total to complete these questionnaires.
You will blow into a device called a spirometer a few times to measure your lung function. You will also be asked to inhale into another device called a negative inspiratory force meter (NIF). This device measures the volume of air that can be inhaled after normal breathing.
The study staff will then record your vital signs (heart rate, breathing rate, blood pressure, and your blood-oxygen level). Your blood-oxygen level will be measured with a device that will be clipped gently onto your fingertip). You will then be asked how hard it is to catch your breath and to rate your level of tiredness.
When instructed, you will walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. This is called the Shuttle Walk Test. The purpose of this timed test is to see how far and fast you can walk without stopping for a rest. You will be asked to pivot briskly around the cones and continue back the other way. You may stop this test at any time if you feel you cannot continue.
After that, you will sit down and rest for up to 1 hour. During this time, the study drug will be prepared, and you may be asked at different times how hard it is to catch your breath.
After the rest period, you will be given the fentanyl to spray into your mouth and under your tongue. About 10 minutes later, you will be asked about any side effects you may be having.
At that point, you will perform a second Shuttle Walk Test. Then the study staff will ask you again about any side effects you may be having, your level of tiredness, and how hard it is to catch your breath. Your vital signs will also be measured. The total distance you walked will also be recorded.
After each walk test, you will also be asked to complete 4 tests of your mental abilities, including finger tapping, simple math questions (addition, subtraction, multiplication, division), recall of numbers, and recall of objects. It should take 15 minutes total to complete these tests.
At the end of the study visit, you will be asked which dose level of the study drug you think you received (high-dose or low-dose). You will also complete a questionnaire about how the study drug may have helped you and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.
At the end of the study, if you think that taking fentanyl helped to improve your breathing, your doctor will be told, so that you and your doctor may discuss if fentanyl would be helpful to you in the future.
Length of Study:
Your active participation in this study is over after you complete the last questionnaire. You will be taken off study if intolerable side effects occur or if you are unable to follow study directions.
Follow-Up:
Fourteen (14) days after your study visit you will be called by the study staff and asked how you are feeling and about any side effects you may be having. This call should last about 10 minutes.
This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. Its use to control shortness of breath is investigational.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Fentanyl Spray Group | Experimental | Drug: Fentanyl Sublingual Spray, Procedure: Shuttle Walk Test, Behavioral: Questionnaires, Behavioral: Mental Ability Tests, Behavioral: Phone CallQuestionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test. |
| High-Dose Fentanyl Spray Group | Experimental | Drug: Fentanyl Sublingual Spray, Procedure: Shuttle Walk Test, Behavioral: Questionnaires, Behavioral: Mental Ability Tests, Behavioral: Phone CallQuestionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of cancer with evidence of active disease
- Breakthrough dyspnea, defined as dyspnea with an average intensity level over the past 7 days of at least 3/10 on a numeric rating scale upon significant exertion or continuous dyspnea </=7/10 with worsening upon significant exertion
- Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology, Cancer Pain Clinic, or Cardiopulmonary clinic
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 80-500 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
Key exclusion criteria (12 listed)
- Dyspnea at rest >/=7/10 at the time of enrollment
- Supplemental oxygen requirement >6 L per minute
- Delirium (i.e. Memorial delirium rating scale >13)
- History of unstable angina or myocardial infarction 1 month prior to study enrollment
- Resting heart rate >120 at the time of study enrollment
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 |
|---|---|---|
| Fentanyl Sublingual SprayAlso: Fentanyl SL Spray, FSSLow-dose Fentanyl Goup: 15-25% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test. High-Dose Fentanyl Group: 35-45% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test. | Drug | High-Dose Fentanyl Spray Group, Low-Dose Fentanyl Spray Group |
| Shuttle Walk TestParticipants walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. After one hour Fentanyl Spray delivered, then second walk test performed. | Procedure or surgery | High-Dose Fentanyl Spray Group, Low-Dose Fentanyl Spray Group |
| QuestionnairesAlso: SurveysQuestionnaire completed about any breathing problems or other symptoms participant may be having at baseline. End of study questionnaire asks which dose level of study drug participant thinks they received. Participant also completes a questionnaire about how study drug may have helped them and how satisfied they are with the study. It should take about 5 minutes to complete the questionnaire. | Behavioural | High-Dose Fentanyl Spray Group, Low-Dose Fentanyl Spray Group |
| Mental Ability TestsAfter each walk test, participant completes 4 tests of their mental abilities. It should take 15 minutes total to complete these tests. | Behavioural | High-Dose Fentanyl Spray Group, Low-Dose Fentanyl Spray Group |
| Phone CallThirty days study visit participant called by study staff. This call should last about 10 minutes. | Behavioural | High-Dose Fentanyl Spray Group, Low-Dose Fentanyl Spray Group |
Primary outcome
Modified Dyspnea Borg Scale (Dyspnea Intensity)
Time frame: Before and after the first and second shuttle walk tests
The primary outcome was dyspnea intensity "now" using the modified Borg scale, which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. This scale has been validated in multiple studies, with a minimal clinically significant difference of 1 point.
4 secondary outcomes
Modified Dyspnea Borg Scale (Dyspnea Unpleasantness)
Time frame: Before and after the first and second shuttle walk tests
Walk Distance
Time frame: After the first shuttle walk test and after the second shuttle walk test
Walk Time
Time frame: After the first shuttle walk test and after the second shuttle walk test
Fatigue Modified Borg Score
Time frame: Before and after the first and second shuttle walk tests
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Advanced Cancers
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
David Hui, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fentanyl Sublingual Spray, Shuttle Walk Test and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer 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 8 inclusion and 12 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 9 Feb 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Dec 2020). 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?
Modified Dyspnea Borg Scale (Dyspnea Intensity) (time frame: Before and after the first and second shuttle walk tests). 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 9 Feb 2021.