Interstitial Lung DiseaseNCT06133998
Effects of Incentive Spirometry With and Without Aerobic Exercises in Interstitial Lung Disease
A study testing incentive spirometer with aerobic exercises and incentive spirometry without aerobic exercises in people with Interstitial Lung Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Effects of Incentive spirometry with and without Aerobic exercises on dyspnea, exercise capacity and quality of life in interstitial lung disease Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- incentive spirometer with aerobic exercises and incentive spirometry without aerobic exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Sep 2023to 10 Dec 2023
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients18 to 55 years of age (21)
- Both gender(M/F)
- Diagnosed as ILD ( sarcoidosis,acute interstitial pneumonia etc.)on clinical, radiological, and histopathological basis
- All included patients were clinically stable without exacerbations in the past 1 month.
Who cannot join
- Patients with other significant respiratory disorders such as acute infections, pulmonary tuberculosis, COPD, asthma, bronchiectasis, lung carcinoma, and pneumothorax
- connective tissue disease-associated ILD
- Patients having other co morbid diseases preventing from exercise training, for example, disability due to orthopedic, neurological, and acute cardiac causes
- Physically and mentally unwell to attend the hospital for training
- Already completed or participated in a PR program in the past 1 year
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ittefaq Hospital
Lahore, Punjab Province, 042
sumera abdul hameed, MS, 03104548492, sumera.hameed@riphah.edu.pk
Iqra Akhtar, MSCPPT
About this study
Official title: Effects of Incentive Spirometry With and Without Aerobic Exercises on Dyspnea, Exercise Capacity and Quality of Life in Interstitial Lung Disease
Effects of Incentive spirometry with and without Aerobic exercises on dyspnea, exercise capacity and quality of life in interstitial lung disease
Read the detailed description
Interstitial lung disease is the large group of diseases most of which cause progressive scarring of lung tissue. The scarring associated with interstitial lung disease eventually affects participants ability to breathe and get enough oxygen into participants bloodstream. This is occurring by the long term work in dusty places or factories Randomized control trials will be conducted in DHQ hospital Layyah through the convent sampling techniques on patients which will be allocated through convenience sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. After the conventional treatment Group A will be treated with aerobic exercise and Group B will be treated without the aerobic exercise. In group A check the effect of spirometry with aerobic exercise (walking, jogging, running and cycling) and group B check the effect of spirometry without the aerobic exercise and dyspnea by using the 6 mint walk test, Borage scale, PFT, chest expansions and quality of life questionnaire. investigators apply the aerobic exercise by using the spirometer on the interstitial lung diseases patient and check the effectiveness of dyspnea, exercise capacity and quality of life of the patient. Data will be collect by the questioner and Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Interstitial Lung Disease
- Being tested
- incentive spirometer with aerobic exercises, incentive spirometry without aerobic exercises
- Keywords
- shortness of breath ,cough,fatigue.
- Medical subject headings
- Lung Diseases, Interstitial, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incentive spirometer with aerobic exercisesDevice
Group A: Aerobic exercise (running, jugging, cycling, walking) will be given to the group A for the checking the effect of incentive spirometer
- In sitting position, for the relaxation of body, patient will take a deep breath.
- In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung. This schedule will be following supervised exercise training for a minimum 60 minutes 3 days a week in moderate patient,75 minutes in moderate to vigorous patients and 150 minutes in healthy patients
- We will check the dyspnea of the patient by the borage scale
- We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test
- We will check the quality of life by the questionnaire.
incentive spirometry without aerobic exercisesDevice
Group B: In group B we will check the effects of incentive spirometer without the aerobic exercise.
- In aerobic exercise following treatment protocol will be involve
- In sitting position, for the relaxation of body, patient will take a deep breath.
- In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung.
- We will check the dyspnea of the patient by the borage scale
- We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test
- We will check the quality of life by the questionnaire.
- We will check the chest expansion by measuring tap.
| Study group | Role | What they receive |
|---|---|---|
| incentive spirometry with aerobic exercises | Experimental | Group A: Aerobic exercise (running, jugging, cycling, walking) will be given to the group A for the checking the effect of incentive spirometer
* In sitting position, for the relaxation of body, patient will take a deep breath.
* In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung.
* This schedule will be following supervised exercise training for a minimum 60 minutes 3 days a week in moderate patient,75 minutes in moderate to vigorous patients and 150 minutes in healthy patients
* We will check the dyspnea of the patient by the borage scale
* We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test
* We will check the quality of life by the questionnaire. Receives: Device: incentive spirometer with aerobic exercises |
| incentive spirometry without aerobic exercises | Active comparator | Group B: In group B we will check the effects of incentive spirometer without the aerobic exercise.
* In aerobic exercise following treatment protocol will be involve
* In sitting position, for the relaxation of body, patient will take a deep breath.
* In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung.
* We will check the dyspnea of the patient by the borage scale
* We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test
* We will check the quality of life by the questionnaire.
* We will check the chest expansion by measuring tap. Receives: Device: incentive spirometry without aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC (force vital capacity)
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. Spirometry the most common type of lung function test. It measures how much and how quickly you can move air in and out of your lungs. Measure the values of FVC (force vital capacity) in liters and in predicted % form . Normal value of FVC is 4.75 to 5.5 in male and 3.25 to3.75 in female.
Measured: 6 weeks
The value of FEV1
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. Spirometry the most common type of lung function test. It measures how much and how quickly you can move air in and out of your lungs. Measure the value of FEV1 in liters and in predicted% form. Normal FEV1 in male is3.5to 4.5 and in female is 2.5 to 3.25.
Measured: 6 weeks
Borg scale
This scale use for the measurement of dyspnea (shortness of breath) Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is used in monitoring progress and mode of exercise in cardiac patients as well as in other patient populations undergoing rehabilitation and endurance training. According to the Borg scale maximum value is 9-10which shows the severe pain level in patient and the moderate pain value is 3-4 the minimum pain is values 1-2 .
Measured: 6 weeks
6mint walk test
This test is performing for the measurement of aerobic capacity and endurance. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Measured: 6 weeks
Quality of life questioner
This questioner is use for measure of physical, psychological and emotional wellbeing life. The QOLQ is a validated and reliable questionnaire that measures an individual's physical, psychological, and social well-being. It consists of a set of questions that cover various aspects of quality of life, such as physical health, emotional well-being, social support, and overall satisfaction with life
Measured: 6 weeks
chest expansion
In this test we use the measuring tape for the measurement of chest mobility. Chest expansion, defined as the difference in thoracic girth after maximum inspiration and maximum expiration, is one indicator of chest wall mobility. As it is measured using a measuring tape, it is a simple, inexpensive, and noninvasive tool for assessing chest mobility.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Sep 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sumera abdul hameed, Ms, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133998
- Sponsor's protocol ID
- REC/RCR & AHS/23/0349
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilyy A, El-Nakhal T, Kadlec J, Bartosik W, Tornout FV, Kouritas V. Preoperative training education with incentive spirometry may reduce postoperative pulmonary complications. Asian Cardiovasc Thorac Ann. 2020 Nov;28(9):592-597. doi: 10.1177/0218492320957158. Epub 2020 Sep 11.
PubMed 32915659Larson M, Kim MJ. Respiratory muscle training with the incentive spirometer resistive breathing device. Heart Lung. 1984 Jul;13(4):341-5.
PubMed 6564101Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.
PubMed 11069801Ho SC, Chiang LL, Cheng HF, Lin HC, Sheng DF, Kuo HP, Lin HC. The effect of incentive spirometry on chest expansion and breathing work in patients with chronic obstructive airway diseases: comparison of two methods. Chang Gung Med J. 2000 Feb;23(2):73-9.
PubMed 10835801Rondinel TZ, Correa IF, Hoscheidt LM, Bueno MH, Da Silva LM, Reppold CT, Dal Lago P. Incentive spirometry combined with expiratory positive airway pressure improves asthma control and quality of life in asthma: a randomised controlled trial. J Asthma. 2015 Mar;52(2):220-6. doi: 10.3109/02770903.2014.956890. Epub 2014 Sep 2.
PubMed 25144550
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Incentive Spirometry With and Without Aerobic Exercises on Dyspnea, Exercise Capacity and Quality of Life in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06133998
- Acronym / sponsor ID
- REC/RCR & AHS/23/0349
- Conditions
- Interstitial Lung Disease
- Keywords
- shortness of breath ,cough,fatigue.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 18 Nov 2023 (actual)
- 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.
Effects of Incentive spirometry with and without Aerobic exercises on dyspnea, exercise capacity and quality of life in interstitial lung disease
Detailed description
Interstitial lung disease is the large group of diseases most of which cause progressive scarring of lung tissue. The scarring associated with interstitial lung disease eventually affects participants ability to breathe and get enough oxygen into participants bloodstream. This is occurring by the long term work in dusty places or factories Randomized control trials will be conducted in DHQ hospital Layyah through the convent sampling techniques on patients which will be allocated through convenience sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. After the conventional treatment Group A will be treated with aerobic exercise and Group B will be treated without the aerobic exercise. In group A check the effect of spirometry with aerobic exercise (walking, jogging, running and cycling) and group B check the effect of spirometry without the aerobic exercise and dyspnea by using the 6 mint walk test, Borage scale, PFT, chest expansions and quality of life questionnaire. investigators apply the aerobic exercise by using the spirometer on the interstitial lung diseases patient and check the effectiveness of dyspnea, exercise capacity and quality of life of the patient. Data will be collect by the questioner and Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| incentive spirometry with aerobic exercises | Experimental | Device: incentive spirometer with aerobic exercisesGroup A: Aerobic exercise (running, jugging, cycling, walking) will be given to the group A for the checking the effect of incentive spirometer * In sitting position, for the relaxation of body, patient will take a deep breath. * In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung. * This schedule will be following supervised exercise training for a minimum 60 minutes 3 days a week in moderate patient,75 minutes in moderate to vigorous patients and 150 minutes in healthy patients * We will check the dyspnea of the patient by the borage scale * We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test * We will check the quality of life by the questionnaire. |
| incentive spirometry without aerobic exercises | Active comparator | Device: incentive spirometry without aerobic exercisesGroup B: In group B we will check the effects of incentive spirometer without the aerobic exercise. * In aerobic exercise following treatment protocol will be involve * In sitting position, for the relaxation of body, patient will take a deep breath. * In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung. * We will check the dyspnea of the patient by the borage scale * We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test * We will check the quality of life by the questionnaire. * We will check the chest expansion by measuring tap. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients18 to 55 years of age (21)
- Both gender(M/F)
- Diagnosed as ILD ( sarcoidosis,acute interstitial pneumonia etc.)on clinical, radiological, and histopathological basis
- All included patients were clinically stable without exacerbations in the past 1 month.
Key exclusion criteria (5 listed)
- Patients with other significant respiratory disorders such as acute infections, pulmonary tuberculosis, COPD, asthma, bronchiectasis, lung carcinoma, and pneumothorax
- connective tissue disease-associated ILD
- Patients having other co morbid diseases preventing from exercise training, for example, disability due to orthopedic, neurological, and acute cardiac causes
- Physically and mentally unwell to attend the hospital for training
- Already completed or participated in a PR program in the past 1 year
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 |
|---|---|---|
| incentive spirometer with aerobic exercisesGroup A: Aerobic exercise (running, jugging, cycling, walking) will be given to the group A for the checking the effect of incentive spirometer * In sitting position, for the relaxation of body, patient will take a deep breath. * In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung. This schedule will be following supervised exercise training for a minimum 60 minutes 3 days a week in moderate patient,75 minutes in moderate to vigorous patients and 150 minutes in healthy patients * We will check the dyspnea of the patient by the borage scale * We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test * We will check the quality of life by the questionnaire. | Device | incentive spirometry with aerobic exercises |
| incentive spirometry without aerobic exercisesGroup B: In group B we will check the effects of incentive spirometer without the aerobic exercise. * In aerobic exercise following treatment protocol will be involve * In sitting position, for the relaxation of body, patient will take a deep breath. * In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung. * We will check the dyspnea of the patient by the borage scale * We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test * We will check the quality of life by the questionnaire. * We will check the chest expansion by measuring tap. | Device | incentive spirometry without aerobic exercises |
Primary outcome
FVC (force vital capacity)
Time frame: 6 weeks
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. Spirometry the most common type of lung function test. It measures how much and how quickly you can move air in and out of your lungs. Measure the values of FVC (force vital capacity) in liters and in predicted % form . Normal value of FVC is 4.75 to 5.5 in male and 3.25 to3.75 in female.
The value of FEV1
Time frame: 6 weeks
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. Spirometry the most common type of lung function test. It measures how much and how quickly you can move air in and out of your lungs. Measure the value of FEV1 in liters and in predicted% form. Normal FEV1 in male is3.5to 4.5 and in female is 2.5 to 3.25.
Borg scale
Time frame: 6 weeks
This scale use for the measurement of dyspnea (shortness of breath) Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is used in monitoring progress and mode of exercise in cardiac patients as well as in other patient populations undergoing rehabilitation and endurance training. According to the Borg scale maximum value is 9-10which shows the severe pain level in patient and the moderate pain value is 3-4 the minimum pain is values 1-2 .
6mint walk test
Time frame: 6 weeks
This test is performing for the measurement of aerobic capacity and endurance. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Quality of life questioner
Time frame: 6 weeks
This questioner is use for measure of physical, psychological and emotional wellbeing life. The QOLQ is a validated and reliable questionnaire that measures an individual's physical, psychological, and social well-being. It consists of a set of questions that cover various aspects of quality of life, such as physical health, emotional well-being, social support, and overall satisfaction with life
chest expansion
Time frame: 6 weeks
In this test we use the measuring tape for the measurement of chest mobility. Chest expansion, defined as the difference in thoracic girth after maximum inspiration and maximum expiration, is one indicator of chest wall mobility. As it is measured using a measuring tape, it is a simple, inexpensive, and noninvasive tool for assessing chest mobility.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 32915659Bilyy A, El-Nakhal T, Kadlec J, Bartosik W, Tornout FV, Kouritas V. Preoperative training education with incentive spirometry may reduce postoperative pulmonary complications. Asian Cardiovasc Thorac Ann. 2020 Nov;28(9):592-597. doi: 10.1177/0218492320957158. Epub 2020 Sep 11.
- Background: PubMed 6564101Larson M, Kim MJ. Respiratory muscle training with the incentive spirometer resistive breathing device. Heart Lung. 1984 Jul;13(4):341-5.
- Background: PubMed 11069801Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.
- Background: PubMed 10835801Ho SC, Chiang LL, Cheng HF, Lin HC, Sheng DF, Kuo HP, Lin HC. The effect of incentive spirometry on chest expansion and breathing work in patients with chronic obstructive airway diseases: comparison of two methods. Chang Gung Med J. 2000 Feb;23(2):73-9.
- Background: PubMed 25144550Rondinel TZ, Correa IF, Hoscheidt LM, Bueno MH, Da Silva LM, Reppold CT, Dal Lago P. Incentive spirometry combined with expiratory positive airway pressure improves asthma control and quality of life in asthma: a randomised controlled trial. J Asthma. 2015 Mar;52(2):220-6. doi: 10.3109/02770903.2014.956890. Epub 2014 Sep 2.
- Individual participant dataSharing planned: No
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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.
sumera abdul hameed, Ms principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incentive spirometer with aerobic exercises and incentive spirometry without aerobic exercises in people with Interstitial Lung Disease, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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 Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC (force vital capacity) (time frame: 6 weeks). The study lists 6 primary outcomes in all. 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 NCT06133998, which also lists 5 linked publications.
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 18 Nov 2023.