AsthmaNCT06176742
Comparative Effects of ACBT and Bubble Positive Expiratory Pressure Device in Asthmatic Patients
A study testing Active Cycle Breathing Technique and Bubble Positive Expiratory Pressure Device in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study gap is that in previous studies the effects of bubble-PEP in different diseases have been studied but it's never been studied in asthmatic patients, so the reason behind this study is to see effects of bubble-PEP in Asthmatic Patients. Read more about this study
- Who is it for?
- Ages 31 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Active Cycle Breathing Technique and Bubble Positive Expiratory Pressure Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 1 Feb 2024
- 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 31 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 31 to 40 years
- Male \& Female
- Mild Asthmatic Patients
- Able to perform techniques
- Those who have never taken therapies for asthma before.
- Chronic Asthma
Who cannot join
- Patients with hypertension
- Cardiac diseases
- Any rib fracture
- Previously taken instructions regarding this.
- Any other unstable medical conditions
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
DHQ Hospital
Muzaffargarh, Punjab Province, 34200
Arnab Altaf, 03064585776
Muhammad Talha Javed, MSCPPT
About this study
Official title: Comparative Effects of Active Cycle Breathing Technique and Bubble Positive Expiratory Pressure Device in Asthmatic Patients
The study gap is that in previous studies the effects of bubble-PEP in different diseases have been studied but it's never been studied in asthmatic patients, so the reason behind this study is to see effects of bubble-PEP in Asthmatic Patients.
Read the detailed description
The aim of this study was to determine the effect of Bubble-PEP device compared to ACBT in asthmatic patients. This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group A will be treated with ACBT and group B will be treated with bubble-PEP device. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25
- Conditions
- Asthma
- Being tested
- Active Cycle Breathing Technique, Bubble Positive Expiratory Pressure Device
- Keywords
- Asthma, Active Cycle Breathing Technique, Bubble PEP
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cycle Breathing TechniqueOther
This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group A will be treated with ACBT. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25.
Bubble Positive Expiratory Pressure DeviceOther
This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group B will be treated with bubble-PEP. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25.
| Study group | Role | What they receive |
|---|---|---|
| Bubble Positive Expiratory Pressure Device | Experimental | Diaphragmatic breathing technique will be the baseline treatment. B group will be treated with bubble positive expiratory pressure device. Patients will be encouraged to blow down the tubing into the water, and make bubbles. This creates positive pressure back up the tubing and into patient's airways and lungs. As the pressure holds open your patient's airways, it helps more air to move in and out of their lungs. All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week. Receives: Other: Bubble Positive Expiratory Pressure Device |
| Active Cycle Breathing Technique | Active comparator | Diaphragmatic breathing technique will be the baseline treatment.A group will be treated with active cycle breathing technique. The technique consists of inspiratory hold technique, deep breathing and forced expiration. These are repeated in a cycle until your chest feels clear. You can carry out ACBT when either sitting or lying down.
Physiotherapist will discuss this with you during your physiotherapy assessment. All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week. Receives: Other: Active Cycle Breathing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea 12 Tool
Dyspnea 12 is a valid and reliable measure of breathlessness in patients. It measures the current level of a patients breathlessness severity, incorporating both physical and affective aspects and does not depend on activity limitation. D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items. The time reference period captures the current level of breathlessness experienced by patients as opposed to specifically on the day of the test or in response to a specific activity. Data will be calculated before and after treatment with the help of outcome measure tools.
Measured: Up to 24 weeks
Breathlessness, Cough, and Sputum Scale (BCSS)
The breathlessness, cough and sputum scale (BCSS) is used to predict patient exacerbation by evaluating common symptoms. The BCSS tool measures the patients self reported symptoms in real time. BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms, each on a 5-point scale; from 0 to 4 the higher scores indicate more severe symptoms. Item scores are summed to yield a total score. Data will be calculated before and after treatment with the help of outcome measure tools.
Measured: Upto 24 weeks
Pulmonary Function Test
Pulmonary function tests measure how much air you can exhale, and how quickly. There are several types of pulmonary function graphs that show data from the tests. The test which will be used is FEV1/FVC. This is the amount of air exhaled in the first second, compared with the total amount of air exhaled. It's given as a fraction (ratio) or a percentage. In general, the higher the FEV1/FVC, the better. This test will be done using Spirometer. Data will be calculated before and after treatment with the help of outcome measure tools.
Measured: Upto 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Sep 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnab Altaf, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176742
- Sponsor's protocol ID
- REC/RCR & AHS/23/0330
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santos MD, Milross MA, McKenzie DK, Alison JA. Bubble-positive expiratory pressure device and sputum clearance in bronchiectasis: A randomised cross-over study. Physiother Res Int. 2020 Jul;25(3):e1836. doi: 10.1002/pri.1836. Epub 2020 Feb 29.
PubMed 32113192Phillips J, Hing W, Pope R, Canov A, Harley N, Lee AL. Active cycle of breathing technique versus oscillating PEP therapy versus walking with huffing during an acute exacerbation of bronchiectasis: a randomised, controlled trial protocol. BMC Pulm Med. 2023 Jan 25;23(1):36. doi: 10.1186/s12890-023-02324-8.
PubMed 36698169Mestriner RG, Fernandes RO, Steffen LC, Donadio MV. Optimum design parameters for a therapist-constructed positive-expiratory-pressure therapy bottle device. Respir Care. 2009 Apr;54(4):504-8.
PubMed 19327187Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5.
PubMed 17650355Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.
PubMed 22100537McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
PubMed 25705944Chanez P, Wenzel SE, Anderson GP, Anto JM, Bel EH, Boulet LP, Brightling CE, Busse WW, Castro M, Dahlen B, Dahlen SE, Fabbri LM, Holgate ST, Humbert M, Gaga M, Joos GF, Levy B, Rabe KF, Sterk PJ, Wilson SJ, Vachier I. Severe asthma in adults: what are the important questions? J Allergy Clin Immunol. 2007 Jun;119(6):1337-48. doi: 10.1016/j.jaci.2006.11.702. Epub 2007 Apr 9.
PubMed 17416409Bousquet J, Mantzouranis E, Cruz AA, Ait-Khaled N, Baena-Cagnani CE, Bleecker ER, Brightling CE, Burney P, Bush A, Busse WW, Casale TB, Chan-Yeung M, Chen R, Chowdhury B, Chung KF, Dahl R, Drazen JM, Fabbri LM, Holgate ST, Kauffmann F, Haahtela T, Khaltaev N, Kiley JP, Masjedi MR, Mohammad Y, O'Byrne P, Partridge MR, Rabe KF, Togias A, van Weel C, Wenzel S, Zhong N, Zuberbier T. Uniform definition of asthma severity, control, and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol. 2010 Nov;126(5):926-38. doi: 10.1016/j.jaci.2010.07.019.
PubMed 20926125Wenzel SE. Asthma: defining of the persistent adult phenotypes. Lancet. 2006 Aug 26;368(9537):804-13. doi: 10.1016/S0140-6736(06)69290-8.
PubMed 16935691Murphy AC, Proeschal A, Brightling CE, Wardlaw AJ, Pavord I, Bradding P, Green RH. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma. Thorax. 2012 Aug;67(8):751-3. doi: 10.1136/thoraxjnl-2011-201096. Epub 2012 Mar 21.
PubMed 22436168Mahdaviani SA, Rezaei N, Moradi B, Dorkhosh S, Amirzargar AA, Movahedi M. Proinflammatory cytokine gene polymorphisms among Iranian patients with asthma. J Clin Immunol. 2009 Jan;29(1):57-62. doi: 10.1007/s10875-008-9232-1. Epub 2008 Sep 2.
PubMed 18763028Bousquet J, Dahl R, Khaltaev N. Global alliance against chronic respiratory diseases. Allergy. 2007 Mar;62(3):216-23. doi: 10.1111/j.1398-9995.2007.01307.x.
PubMed 17298337Zuriati Z, Surya M. Effectiveness Active Cycle of Breathing Technique (ACBT) with Pursed Lips Breathing Technique (PLBT) to tripod position in increase oxygen saturation in patients with COPD, West Sumatera. Enfermeria Clinica. 2020 Jun 1;30:164-7.
Eastwood B, Jepsen N, Coulter K, Wong C, Zeng I. Challenges of undertaking a clinical trial using bubble-PEP in an acute exacerbation of chronic obstructive pulmonary disease: A feasibility study. New Zealand Journal of Physiotherapy. 2016 Mar 1;44(1).
Sundus S, Memoona S, Muhammad IN, Rashid HN. Effect of Active Cycle of Breathing Technique in Adult Asthmatic Patients in Pakistan. Asian Journal of Medicine and Biomedicine. 2017 Dec 21;1(1):32-
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Active Cycle Breathing Technique and Bubble Positive Expiratory Pressure Device in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT06176742
- Acronym / sponsor ID
- REC/RCR & AHS/23/0330
- Conditions
- Asthma
- Keywords
- Asthma, Active Cycle Breathing Technique, Bubble PEP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 20 Dec 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.
The study gap is that in previous studies the effects of bubble-PEP in different diseases have been studied but it's never been studied in asthmatic patients, so the reason behind this study is to see effects of bubble-PEP in Asthmatic Patients.
Detailed description
The aim of this study was to determine the effect of Bubble-PEP device compared to ACBT in asthmatic patients. This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group A will be treated with ACBT and group B will be treated with bubble-PEP device. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bubble Positive Expiratory Pressure Device | Experimental | Other: Bubble Positive Expiratory Pressure DeviceDiaphragmatic breathing technique will be the baseline treatment. B group will be treated with bubble positive expiratory pressure device. Patients will be encouraged to blow down the tubing into the water, and make bubbles. This creates positive pressure back up the tubing and into patient's airways and lungs. As the pressure holds open your patient's airways, it helps more air to move in and out of their lungs. All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week. |
| Active Cycle Breathing Technique | Active comparator | Other: Active Cycle Breathing TechniqueDiaphragmatic breathing technique will be the baseline treatment.A group will be treated with active cycle breathing technique. The technique consists of inspiratory hold technique, deep breathing and forced expiration. These are repeated in a cycle until your chest feels clear. You can carry out ACBT when either sitting or lying down. Physiotherapist will discuss this with you during your physiotherapy assessment. All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week. |
Who may qualify
- Ages
- 31 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 31 to 40 years
- Male \& Female
- Mild Asthmatic Patients
- Able to perform techniques
- Those who have never taken therapies for asthma before.
Key exclusion criteria (5 listed)
- Patients with hypertension
- Cardiac diseases
- Any rib fracture
- Previously taken instructions regarding this.
- Any other unstable medical conditions
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 |
|---|---|---|
| Active Cycle Breathing TechniqueThis study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group A will be treated with ACBT. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25. | Other | Active Cycle Breathing Technique |
| Bubble Positive Expiratory Pressure DeviceThis study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group B will be treated with bubble-PEP. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25. | Other | Bubble Positive Expiratory Pressure Device |
Primary outcome
Dyspnea 12 Tool
Time frame: Up to 24 weeks
Dyspnea 12 is a valid and reliable measure of breathlessness in patients. It measures the current level of a patients breathlessness severity, incorporating both physical and affective aspects and does not depend on activity limitation. D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items. The time reference period captures the current level of breathlessness experienced by patients as opposed to specifically on the day of the test or in response to a specific activity. Data will be calculated before and after treatment with the help of outcome measure tools.
Breathlessness, Cough, and Sputum Scale (BCSS)
Time frame: Upto 24 weeks
The breathlessness, cough and sputum scale (BCSS) is used to predict patient exacerbation by evaluating common symptoms. The BCSS tool measures the patients self reported symptoms in real time. BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms, each on a 5-point scale; from 0 to 4 the higher scores indicate more severe symptoms. Item scores are summed to yield a total score. Data will be calculated before and after treatment with the help of outcome measure tools.
Pulmonary Function Test
Time frame: Upto 24 weeks
Pulmonary function tests measure how much air you can exhale, and how quickly. There are several types of pulmonary function graphs that show data from the tests. The test which will be used is FEV1/FVC. This is the amount of air exhaled in the first second, compared with the total amount of air exhaled. It's given as a fraction (ratio) or a percentage. In general, the higher the FEV1/FVC, the better. This test will be done using Spirometer. Data will be calculated before and after treatment with the help of outcome measure tools.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 32113192Santos MD, Milross MA, McKenzie DK, Alison JA. Bubble-positive expiratory pressure device and sputum clearance in bronchiectasis: A randomised cross-over study. Physiother Res Int. 2020 Jul;25(3):e1836. doi: 10.1002/pri.1836. Epub 2020 Feb 29.
- Background: PubMed 36698169Phillips J, Hing W, Pope R, Canov A, Harley N, Lee AL. Active cycle of breathing technique versus oscillating PEP therapy versus walking with huffing during an acute exacerbation of bronchiectasis: a randomised, controlled trial protocol. BMC Pulm Med. 2023 Jan 25;23(1):36. doi: 10.1186/s12890-023-02324-8.
- Background: PubMed 19327187Mestriner RG, Fernandes RO, Steffen LC, Donadio MV. Optimum design parameters for a therapist-constructed positive-expiratory-pressure therapy bottle device. Respir Care. 2009 Apr;54(4):504-8.
- Background: PubMed 17650355Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5.
- Background: PubMed 22100537Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.
- Background: PubMed 25705944McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
- Background: PubMed 17416409Chanez P, Wenzel SE, Anderson GP, Anto JM, Bel EH, Boulet LP, Brightling CE, Busse WW, Castro M, Dahlen B, Dahlen SE, Fabbri LM, Holgate ST, Humbert M, Gaga M, Joos GF, Levy B, Rabe KF, Sterk PJ, Wilson SJ, Vachier I. Severe asthma in adults: what are the important questions? J Allergy Clin Immunol. 2007 Jun;119(6):1337-48. doi: 10.1016/j.jaci.2006.11.702. Epub 2007 Apr 9.
- Background: PubMed 20926125Bousquet J, Mantzouranis E, Cruz AA, Ait-Khaled N, Baena-Cagnani CE, Bleecker ER, Brightling CE, Burney P, Bush A, Busse WW, Casale TB, Chan-Yeung M, Chen R, Chowdhury B, Chung KF, Dahl R, Drazen JM, Fabbri LM, Holgate ST, Kauffmann F, Haahtela T, Khaltaev N, Kiley JP, Masjedi MR, Mohammad Y, O'Byrne P, Partridge MR, Rabe KF, Togias A, van Weel C, Wenzel S, Zhong N, Zuberbier T. Uniform definition of asthma severity, control, and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol. 2010 Nov;126(5):926-38. doi: 10.1016/j.jaci.2010.07.019.
- Background: PubMed 16935691Wenzel SE. Asthma: defining of the persistent adult phenotypes. Lancet. 2006 Aug 26;368(9537):804-13. doi: 10.1016/S0140-6736(06)69290-8.
- Background: PubMed 22436168Murphy AC, Proeschal A, Brightling CE, Wardlaw AJ, Pavord I, Bradding P, Green RH. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma. Thorax. 2012 Aug;67(8):751-3. doi: 10.1136/thoraxjnl-2011-201096. Epub 2012 Mar 21.
- Background: PubMed 18763028Mahdaviani SA, Rezaei N, Moradi B, Dorkhosh S, Amirzargar AA, Movahedi M. Proinflammatory cytokine gene polymorphisms among Iranian patients with asthma. J Clin Immunol. 2009 Jan;29(1):57-62. doi: 10.1007/s10875-008-9232-1. Epub 2008 Sep 2.
- Background: PubMed 17298337Bousquet J, Dahl R, Khaltaev N. Global alliance against chronic respiratory diseases. Allergy. 2007 Mar;62(3):216-23. doi: 10.1111/j.1398-9995.2007.01307.x.
- Individual participant dataSharing planned: No
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Asthma
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.
Arnab Altaf 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 Active Cycle Breathing Technique and Bubble Positive Expiratory Pressure Device in people with Asthma, 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 6 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 20 Dec 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?
Dyspnea 12 Tool (time frame: Up to 24 weeks). The study lists 3 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 NCT06176742, which also lists 15 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 20 Dec 2023.