Advanced CancersPhase 2NCT01670097
Dexamethasone Dyspnea Study
A Phase 2 study testing Dexamethasone, Questionnaires and Spirometer in people with Advanced Cancers and Hematologic Disorder, 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 dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Hematologic Disorder, Solid Tumors
- What is being tested?
- Dexamethasone, Questionnaires and Spirometer
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 26 Jan 2021
- Phase
- Phase 2
- 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
- Dyspnea with an average intensity level >3/10 on the numeric rating scale over the past week
- Clinical or radiologic history of lung/pleural involvement (primary or metastatic), lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration
- Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation Service, Thoracic Oncology or Pulmonary Medicine
- Able to communicate in English
- Karnofsky performance status >=40%
- Age 18 or older
- Permission from the attending medical oncologist if the patient is currently on an interventional cancer therapy trial.
Who cannot join
- Delirium (i.e. Memorial delirium rating scale >13)
- Oxygen saturation <90% despite supplemental oxygen >6L/min
- Previous allergic reactions to dexamethasone
- Uncontrolled hyperglycemia as defined by any blood glucose of >300 mg/dl in the past two weeks
- Severe anemia (Hb <7g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)
- Post-surgical open wound that has not been healed at the time of enrollment
Show all 15Show fewer
- Any infection requiring parenteral antibiotics within the past 2 weeks
- Major surgery within the past 2 weeks
- Megestrol use at the time of study enrollment
- Neutropenia (absolute neutrophil count < 1.0) (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)
- Currently on or expected to start cytotoxic chemotherapy with in 1 week of study enrollment
- Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment
- Heart failure exacerbation at the time of study enrollment
- Chronic systemic corticosteroid use (>14 days) at the time of study enrollment
- 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 Dexamethasone for Dyspnea in Cancer Patients
The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo.
Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Read the detailed description
Baseline Tests:
If you are found to be eligible to take part in this study, you will have baseline tests after completing the screening questionnaires. The following tests and procedures will be performed:
- Information will be collected from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
- Your breathing rate will be measured.
- The amount of oxygen in your body will be measured using a machine that clips on your finger.
- You will blow into a device called a spirometer a few times to measure your lung function.
- You will be asked to answer 4 questionnaires. The first questionnaire asks you to rate your level of symptoms, such as pain, tiredness, sleep, appetite, depression, anxiety, and drowsiness. The second questionnaire asks about your sensation of breathing. The third questionnaire asks you to rate the intensity of your shortness of breath. The last questionnaire asks about your quality of life. These questionnaires should take a total of about 40 minutes to complete.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- If you are in Group 1, you will receive dexamethasone.
- If you are in Group 2, you will receive a placebo for 7 days, then dexamethasone for 7 days.
You will have an equal chance of being assigned to either group. Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug/Placebo Administration:
After your baseline tests, you will be given a supply of either the study drug or the placebo to bring home.
Starting the next morning, you will take 2 dexamethasone or placebo capsules twice a day by mouth for 4 days. Then, you will take 1 tablet twice a day for 3 more days.
After the first 7 days, no matter which group you have been assigned to, you will only take 1 dexamethasone capsule twice a day for 7 more days
You should take the capsules around 8 o'clock in the morning and 4 o'clock in the afternoon. You should take the capsules with food and 8 ounces of water.
You will also receive a portable spirometer to test your lung function. You should blow into the machine 1 time a day.
Study Visits/Calls:
On Days 7 and 14, you will return to the clinic or be called by phone. You should bring your capsule boxes with you if you come to the clinic, or have them with you if you are called so the study staff can count the number of capsules. The following tests and procedures will be performed:
- You will be asked to complete the same 4 questionnaires you completed during your baseline tests.
- You will also be asked about any side effects you may be having and if you think the study drug is helping your shortness of breath.
- You will blow into a spirometer to measure your lung function.
During the 14 days you will be taking either the study drug or the placebo on the study, you will be called by phone 1 time each day to ask you about your level of shortness of breath and to remind you to take the capsules. These calls should last about 5 minutes.
Length of Study:
You may continue taking the study drug for up to 14 days, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if intolerable side effects occur or if you are unable to follow study directions.
Your participation on the study will be over when you have completed the follow-up calls and visit.
This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of pain, nausea and tiredness. Its use to help control shortness of breath is investigational.
Up to 40 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers, Hematologic Disorder, Solid Tumors
- Being tested
- Dexamethasone, Placebo, Questionnaires, Spirometer, Phone Calls
- Keywords
- Advanced Cancers, Hematologic Disorder, Solid Tumors, Dyspnea, Difficulty breathing, Shortness of breath, Dexamethasone, Decadron, Placebo, Sugar pill, Questionnaires, Surveys, Spirometer, Phone calls
- Medical subject headings
- Hematologic Diseases, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days.
Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.
PlaceboDrug
Also called Sugar pill
Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
SpirometerDevice
Patient to blow into spirometry machine 1 time a day to test lung function.
Phone CallsOther
Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days. Receives: Drug: Dexamethasone; Behavioral: Questionnaires; Device: Spirometer; Other: Phone Calls |
| Placebo | Placebo comparator | Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days. Receives: Drug: Dexamethasone; Drug: Placebo; Behavioral: Questionnaires; Device: Spirometer; Other: Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed the Dyspnea Numeric Rating Scale
Number of participants who completed the dyspnea numeric rating scale on Day 7
Measured: Baseline to Day 7
Secondary outcomes (3)
Edmonton Symptom Assessment System Dyspnea Score
The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.
Measured: Baseline to Day 4, Day 7, Day 14
Dyspnea Numeric Rating Score (Now)
Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.
Measured: Baseline to day 4, Day 7 and Day 14
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week ("Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.
Measured: Baseline to day 4, Day 7 and Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2020
- Study completion26 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670097
- Sponsor's protocol ID
- 2012-0001
- Other IDs
- NCI-2012-01615
- Status last verified
- Jan 2021
- First submitted
- 17 Aug 2012
- Last updated
- 17 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hui D, Kilgore K, Frisbee-Hume S, Park M, Tsao A, Delgado Guay M, Lu C, William W Jr, Pisters K, Eapen G, Fossella F, Amin S, Bruera E. Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial. J Pain Symptom Manage. 2016 Jul;52(1):8-16.e1. doi: 10.1016/j.jpainsymman.2015.10.023. Epub 2016 Jun 18.
PubMed 27330023
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients
- ClinicalTrials.gov ID
- NCT01670097
- Acronym / sponsor ID
- 2012-0001
- Conditions
- Advanced Cancers, Hematologic Disorder, Solid Tumors
- Keywords
- Advanced Cancers, Hematologic Disorder, Solid Tumors, Dyspnea, Difficulty breathing, Shortness of breath, Dexamethasone, Decadron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Posted 1 Feb 2021
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 dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo.
Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Detailed description
Baseline Tests:
If you are found to be eligible to take part in this study, you will have baseline tests after completing the screening questionnaires. The following tests and procedures will be performed:
- Information will be collected from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
- Your breathing rate will be measured.
- The amount of oxygen in your body will be measured using a machine that clips on your finger.
- You will blow into a device called a spirometer a few times to measure your lung function.
- You will be asked to answer 4 questionnaires. The first questionnaire asks you to rate your level of symptoms, such as pain, tiredness, sleep, appetite, depression, anxiety, and drowsiness. The second questionnaire asks about your sensation of breathing. The third questionnaire asks you to rate the intensity of your shortness of breath. The last questionnaire asks about your quality of life. These questionnaires should take a total of about 40 minutes to complete.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- If you are in Group 1, you will receive dexamethasone.
- If you are in Group 2, you will receive a placebo for 7 days, then dexamethasone for 7 days.
You will have an equal chance of being assigned to either group. Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug/Placebo Administration:
After your baseline tests, you will be given a supply of either the study drug or the placebo to bring home.
Starting the next morning, you will take 2 dexamethasone or placebo capsules twice a day by mouth for 4 days. Then, you will take 1 tablet twice a day for 3 more days.
After the first 7 days, no matter which group you have been assigned to, you will only take 1 dexamethasone capsule twice a day for 7 more days
You should take the capsules around 8 o'clock in the morning and 4 o'clock in the afternoon. You should take the capsules with food and 8 ounces of water.
You will also receive a portable spirometer to test your lung function. You should blow into the machine 1 time a day.
Study Visits/Calls:
On Days 7 and 14, you will return to the clinic or be called by phone. You should bring your capsule boxes with you if you come to the clinic, or have them with you if you are called so the study staff can count the number of capsules. The following tests and procedures will be performed:
- You will be asked to complete the same 4 questionnaires you completed during your baseline tests.
- You will also be asked about any side effects you may be having and if you think the study drug is helping your shortness of breath.
- You will blow into a spirometer to measure your lung function.
During the 14 days you will be taking either the study drug or the placebo on the study, you will be called by phone 1 time each day to ask you about your level of shortness of breath and to remind you to take the capsules. These calls should last about 5 minutes.
Length of Study:
You may continue taking the study drug for up to 14 days, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if intolerable side effects occur or if you are unable to follow study directions.
Your participation on the study will be over when you have completed the follow-up calls and visit.
This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of pain, nausea and tiredness. Its use to help control shortness of breath is investigational.
Up to 40 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone, Behavioral: Questionnaires, Device: Spirometer, Other: Phone CallsDexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days. |
| Placebo | Placebo comparator | Drug: Dexamethasone, Drug: Placebo, Behavioral: Questionnaires, Device: Spirometer, Other: Phone CallsTwo placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days. |
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
- Dyspnea with an average intensity level >3/10 on the numeric rating scale over the past week
- Clinical or radiologic history of lung/pleural involvement (primary or metastatic), lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration
- Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation Service, Thoracic Oncology or Pulmonary Medicine
- Able to communicate in English
Key exclusion criteria (15 listed)
- Delirium (i.e. Memorial delirium rating scale >13)
- Oxygen saturation <90% despite supplemental oxygen >6L/min
- Previous allergic reactions to dexamethasone
- Uncontrolled hyperglycemia as defined by any blood glucose of >300 mg/dl in the past two weeks
- Severe anemia (Hb <7g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)
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 |
|---|---|---|
| DexamethasoneAlso: DecadronGroup 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days. | Drug | Dexamethasone, Placebo |
| PlaceboAlso: Sugar pillGroup 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days. | Drug | Placebo |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. | Behavioural | Dexamethasone, Placebo |
| SpirometerPatient to blow into spirometry machine 1 time a day to test lung function. | Device | Dexamethasone, Placebo |
| Phone CallsPatient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes. | Other | Dexamethasone, Placebo |
Primary outcome
Number of Participants Who Completed the Dyspnea Numeric Rating Scale
Time frame: Baseline to Day 7
Number of participants who completed the dyspnea numeric rating scale on Day 7
3 secondary outcomes
Edmonton Symptom Assessment System Dyspnea Score
Time frame: Baseline to Day 4, Day 7, Day 14
Dyspnea Numeric Rating Score (Now)
Time frame: Baseline to day 4, Day 7 and Day 14
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea
Time frame: Baseline to day 4, Day 7 and Day 14.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27330023Hui D, Kilgore K, Frisbee-Hume S, Park M, Tsao A, Delgado Guay M, Lu C, William W Jr, Pisters K, Eapen G, Fossella F, Amin S, Bruera E. Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial. J Pain Symptom Manage. 2016 Jul;52(1):8-16.e1. doi: 10.1016/j.jpainsymman.2015.10.023. Epub 2016 Jun 18.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
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 study testing Dexamethasone, Questionnaires and Spirometer in people with Advanced Cancers and Hematologic Disorder, 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 15 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 17 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Feb 2021). 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?
Number of Participants Who Completed the Dyspnea Numeric Rating Scale (time frame: Baseline to Day 7). 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 NCT01670097, 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 17 Feb 2021.