COPDNCT06189196
Effects of Blow Bottle Verses ACBTs Technique in Patients of Chronic Obstructive Pulmonary Disease
A study testing BLOW BOTTLE and ACBT in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic obstructive pulmonary disease is a common disease worldwide. Pulmonary rehabilitation is an important part to decrease the complications of COPD. Blow bottle technique is an economical and subjective technique promote the lung expansion, as compare to ACBTs. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- COPD
- What is being tested?
- BLOW BOTTLE and ACBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Aug 2023to 31 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate COPD
- Hx of chronic sputum production
- Regular expectoration
- After 48 hours of admission in hospital
- Patient of 45 to 65 years
- Both genders (male and female)
Who cannot join
- Pulmonary disease like, Bronchiectasis, pneumothorax, TB, atelectasis
- Lung Abscess
- Lung cancer
- Any post-surgical (pneumectomy, lobectomy)
- Hemoptysis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Hospital
Lahore, Punjab Province, 5400
Dr Arif, PhD, 03338523002, drarifgdpgmi@gmail.com
wajeeha Zia, phd*, 03234500788, wajeeha.zia@riphah.edu.pk
About this study
Chronic obstructive pulmonary disease is a common disease worldwide. Pulmonary rehabilitation is an important part to decrease the complications of COPD. Blow bottle technique is an economical and subjective technique promote the lung expansion, as compare to ACBTs. It used to treat the different complications in COPD patients and also decrease the dependency of patient. To find the comparative effects of blow bottle and active cycle of breathing on sputum diary, oxygen saturation, pulmonary function and quality of life among the patients of chronic bronchitis.
A randomized clinical trial will be conducted at Gulab Devi hospital Lahore. Through convenient sampling technique on 56 patients, allocated through simple random sampling through computer generated technique into group A and Group B. Group A will be treated with blow bottle technique and group B will be treated by with ACBTs. Pretreatment values will be recorded for BCSS for sputum, pulse oximeter, pulmonary function test and st. George for quality of life will be assessed before and after 8 weeks of the treatment. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
Read the detailed description
Chronic obstructive pulmonary disease is defined as chronic airflow obstruction that is progressive. Patients with chronic obstructive pulmonary disease (COPD) are highly susceptible from respiratory exacerbations from viral respiratory tract infections. The pathological consequences of the COPD inflammation Induce series of physiological changes which eventually impact the quality of life and survival in the natural progress of COPD. Elastin proteolysis results in reduction in elastic recoil Pressures in the lungs, also the integrity and movement Of air in the bronchioles results in significant airway narrowing with air-trapping in lungs.
COPD is an increasingly important cause of morbidity, disability, and mortality worldwide. Researcher aimed to estimate global, regional, and national COPD prevalence and risk factors to guide policy and population interventions. Chronic Obstructive Pulmonary Disease (COPD) is attributable to household air pollution and is known to increase the Disability Adjusted Life Years (DALYs), morbidity and mortality and women are most susceptible groups for the exposure. In order to understand the global risk among women with COPD due to exposure of household air pollutants.
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Smoking remains the most important risk factor, but occupational exposures may play an essential role as well n 2019, Thirty-two sources of COPD prevalence rates, representing 17 countries and eight World Health Organization-classified regions, were identified and reviewed. Reported prevalence ranged from 0.23 to 18.3%. The lowest prevalence rates 0.2 to 2.5% were based on expert opinion. Sixteen studies had measured rates that could reasonably be extrapolated to an entire region or country.
The physiotherapist has a major role to assume in pre and post-exacerbation management of people with COPD and assess the patient and to put into place an individualized pulmonary rehabilitation program. In patients with a range of respiratory disorders such as chronic bronchitis, different technique are available for pulmonary rehabilitation, such as active cycle of breathing techniques which includes cycle of breathing control, thoracic expansion exercises and forced expiratory technique (FET), appears to have beneficial effects.
Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life. Therefore, researcher have designed a lung function exercise bottle, which is capable of adjusting the pressure according to the patient's needs. The blowpipe can be inserted into the bottle body and the patient can blow the air through the tube. the air pressure in the bottle can be adjusted, with the advantage of wider range of application, lower cost and more convenient.
Secretion production and retention is top most complication of chronic obstructive pulmonary disease. First step of its management is removal of secretion as soon as possible to prevent infection and development of further complications. ACBT is one of most commonly used technique used in all times. But blow bottle is not only economic but also provide direct visual stimulus during performance to enhance patient interest. So it is necessity to find out the comparison of these two technique which will help to get the better quality of life, reduce the severity of disease and improve the pulmonary function.
- Conditions
- COPD
- Being tested
- BLOW BOTTLE, ACBT
- Keywords
- Active cycle of breathing technique, Breathlessness, Cough, Chronic Obstructive Pulmonary Disease,, Sputum, Quality Of Life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOW BOTTLEDevice
Blow Bottle PEP' is the cost-effective device comparative to other PEP devices. Treatment (CPT) along with BBPEP twice a day. Therapist made a cost-effective BBPEP which generates 10 cm of H2O PEP and it was given for 10 breaths, 3 sets with 5 second hold.
ACBTOther
Active cycle of breathing technique (ACBT) is an alternative airway clearance technique. A typical ACBT cycle consists of breathing control, three to four thoracic expansion exercises, and a forced expiratory technique (huffing). ACBT has been shown to improve short-term secretion clearance in patients with chronic lung disease. It is also flexible, tolerated, and accepted well by patients. Although ACBT is widely used in patients with respiratory conditions characterized by chronic sputum production.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | BLOW BOTTLE Receives: Device: BLOW BOTTLE |
| Group B | Experimental | ACBT Receives: Other: ACBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness, Cough and Sputum Scale (BCSS).
This scale is used to measure severity of breathlessness, cough and sputum. It is consist of 5 levels 0 to 4. In which 0 means unaware of difficulty,1 means mild,2 means moderate, 3 means marked and 4 means severe difficulty.
Measured: 5thy day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start18 Aug 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajeeha Zia, phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189196
- Sponsor's protocol ID
- Maryam Riphah
- Status last verified
- Dec 2023
- First submitted
- 18 Aug 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
PubMed 18046898Gerayeli FV, Milne S, Cheung C, Li X, Yang CWT, Tam A, Choi LH, Bae A, Sin DD. COPD and the risk of poor outcomes in COVID-19: A systematic review and meta-analysis. EClinicalMedicine. 2021 Mar;33:100789. doi: 10.1016/j.eclinm.2021.100789. Epub 2021 Mar 18.
PubMed 33758801Brashier BB, Kodgule R. Risk factors and pathophysiology of chronic obstructive pulmonary disease (COPD). J Assoc Physicians India. 2012 Feb;60 Suppl:17-21. No abstract available.
PubMed 23155808Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.
PubMed 35279265Kamal R, Srivastava AK, Kesavachandran CN, Bihari V, Singh A. Chronic obstructive pulmonary disease (COPD) in women due to indoor biomass burning: a meta analysis. Int J Environ Health Res. 2022 Jun;32(6):1403-1417. doi: 10.1080/09603123.2021.1887460. Epub 2021 Feb 12.
PubMed 33573386Rajnoveanu AG, Rajnoveanu RM, Motoc NS, Postolache P, Gusetu G, Man MA. COPD in Firefighters: A Specific Event-Related Condition Rather than a Common Occupational Respiratory Disorder. Medicina (Kaunas). 2022 Feb 5;58(2):239. doi: 10.3390/medicina58020239.
PubMed 35208563Halbert RJ, Isonaka S, George D, Iqbal A. Interpreting COPD prevalence estimates: what is the true burden of disease? Chest. 2003 May;123(5):1684-92. doi: 10.1378/chest.123.5.1684.
PubMed 12740290Medrinal C, Bonnevie T. [Physiotherapy during and after acute exacerbation of COPD]. Rev Mal Respir. 2022 Apr;39(4):386-397. doi: 10.1016/j.rmr.2022.02.056. Epub 2022 Feb 24. French.
PubMed 35221161Mansha H, Rashid S, Khalid MU, Khan RR, Hassan M, Khalid H. Effects of Active Cycle of Breathing Techniques on quality of life in patients with Chronic Bronchitis. Foundation University Journal of Rehabilitation Sciences. 2022;2(2):40-5.
Liu H, Zhang X, Zhang Y. [Design and application of a pulmonary function exercise bottle]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2019 Feb;31(2):236-237. doi: 10.3760/cma.j.issn.2095-4352.2019.02.023. Chinese.
PubMed 30827317Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27.
PubMed 35235877Hichkad S, Ganesh B. Effect of blow bottle device and flutter on functional capacity, dyspnea, fatigue, and peak expiratory flow rate in mild-to-moderate COPD patients: A comparative study. Indian Journal of Respiratory Care. 2021;10(3):294.
Pakpahan R, Tarigan AP. The Effect of the Combination of Chest Physiotherapy and Active Cycle Breathing Technique on Respiratory Rate and Ability to Expend Sputum in Chronic Exacerbation Obstructive Lung Disease Patients at Haji Adam Malik Hospital Medan. European Journal of Molecular & Clinical Medicine. 2021;8(3):616-23.
Zuriati 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;30:164-7.
Shen M, Li Y, Ding X, Xu L, Li F, Lin H. Effect of active cycle of breathing techniques in patients with chronic obstructive pulmonary disease: a systematic review of intervention. Eur J Phys Rehabil Med. 2020 Oct;56(5):625-632. doi: 10.23736/S1973-9087.20.06144-4. Epub 2020 May 13.
PubMed 32397703
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blow Bottle Verses ACBTs Technique in Patients of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06189196
- Acronym / sponsor ID
- Maryam Riphah
- Conditions
- COPD
- Keywords
- Active cycle of breathing technique, Breathlessness, Cough, Chronic Obstructive Pulmonary Disease,, Sputum, Quality Of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Jan 2024 (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.
Chronic obstructive pulmonary disease is a common disease worldwide. Pulmonary rehabilitation is an important part to decrease the complications of COPD. Blow bottle technique is an economical and subjective technique promote the lung expansion, as compare to ACBTs. It used to treat the different complications in COPD patients and also decrease the dependency of patient. To find the comparative effects of blow bottle and active cycle of breathing on sputum diary, oxygen saturation, pulmonary function and quality of life among the patients of chronic bronchitis.
A randomized clinical trial will be conducted at Gulab Devi hospital Lahore. Through convenient sampling technique on 56 patients, allocated through simple random sampling through computer generated technique into group A and Group B. Group A will be treated with blow bottle technique and group B will be treated by with ACBTs. Pretreatment values will be recorded for BCSS for sputum, pulse oximeter, pulmonary function test and st. George for quality of life will be assessed before and after 8 weeks of the treatment. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
Detailed description
Chronic obstructive pulmonary disease is defined as chronic airflow obstruction that is progressive. Patients with chronic obstructive pulmonary disease (COPD) are highly susceptible from respiratory exacerbations from viral respiratory tract infections. The pathological consequences of the COPD inflammation Induce series of physiological changes which eventually impact the quality of life and survival in the natural progress of COPD. Elastin proteolysis results in reduction in elastic recoil Pressures in the lungs, also the integrity and movement Of air in the bronchioles results in significant airway narrowing with air-trapping in lungs.
COPD is an increasingly important cause of morbidity, disability, and mortality worldwide. Researcher aimed to estimate global, regional, and national COPD prevalence and risk factors to guide policy and population interventions. Chronic Obstructive Pulmonary Disease (COPD) is attributable to household air pollution and is known to increase the Disability Adjusted Life Years (DALYs), morbidity and mortality and women are most susceptible groups for the exposure. In order to understand the global risk among women with COPD due to exposure of household air pollutants.
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Smoking remains the most important risk factor, but occupational exposures may play an essential role as well n 2019, Thirty-two sources of COPD prevalence rates, representing 17 countries and eight World Health Organization-classified regions, were identified and reviewed. Reported prevalence ranged from 0.23 to 18.3%. The lowest prevalence rates 0.2 to 2.5% were based on expert opinion. Sixteen studies had measured rates that could reasonably be extrapolated to an entire region or country.
The physiotherapist has a major role to assume in pre and post-exacerbation management of people with COPD and assess the patient and to put into place an individualized pulmonary rehabilitation program. In patients with a range of respiratory disorders such as chronic bronchitis, different technique are available for pulmonary rehabilitation, such as active cycle of breathing techniques which includes cycle of breathing control, thoracic expansion exercises and forced expiratory technique (FET), appears to have beneficial effects.
Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life. Therefore, researcher have designed a lung function exercise bottle, which is capable of adjusting the pressure according to the patient's needs. The blowpipe can be inserted into the bottle body and the patient can blow the air through the tube. the air pressure in the bottle can be adjusted, with the advantage of wider range of application, lower cost and more convenient.
Secretion production and retention is top most complication of chronic obstructive pulmonary disease. First step of its management is removal of secretion as soon as possible to prevent infection and development of further complications. ACBT is one of most commonly used technique used in all times. But blow bottle is not only economic but also provide direct visual stimulus during performance to enhance patient interest. So it is necessity to find out the comparison of these two technique which will help to get the better quality of life, reduce the severity of disease and improve the pulmonary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: BLOW BOTTLEBLOW BOTTLE |
| Group B | Experimental | Other: ACBTACBT |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate COPD
- Hx of chronic sputum production
- Regular expectoration
- After 48 hours of admission in hospital
- Patient of 45 to 65 years
Key exclusion criteria (5 listed)
- Pulmonary disease like, Bronchiectasis, pneumothorax, TB, atelectasis
- Lung Abscess
- Lung cancer
- Any post-surgical (pneumectomy, lobectomy)
- Hemoptysis
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 |
|---|---|---|
| BLOW BOTTLEBlow Bottle PEP' is the cost-effective device comparative to other PEP devices. Treatment (CPT) along with BBPEP twice a day. Therapist made a cost-effective BBPEP which generates 10 cm of H2O PEP and it was given for 10 breaths, 3 sets with 5 second hold. | Device | Group A |
| ACBTActive cycle of breathing technique (ACBT) is an alternative airway clearance technique. A typical ACBT cycle consists of breathing control, three to four thoracic expansion exercises, and a forced expiratory technique (huffing). ACBT has been shown to improve short-term secretion clearance in patients with chronic lung disease. It is also flexible, tolerated, and accepted well by patients. Although ACBT is widely used in patients with respiratory conditions characterized by chronic sputum production. | Other | Group B |
Primary outcome
Breathlessness, Cough and Sputum Scale (BCSS).
Time frame: 5thy day
This scale is used to measure severity of breathlessness, cough and sputum. It is consist of 5 levels 0 to 4. In which 0 means unaware of difficulty,1 means mild,2 means moderate, 3 means marked and 4 means severe difficulty.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 18046898Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
- Background: PubMed 33758801Gerayeli FV, Milne S, Cheung C, Li X, Yang CWT, Tam A, Choi LH, Bae A, Sin DD. COPD and the risk of poor outcomes in COVID-19: A systematic review and meta-analysis. EClinicalMedicine. 2021 Mar;33:100789. doi: 10.1016/j.eclinm.2021.100789. Epub 2021 Mar 18.
- Background: PubMed 23155808Brashier BB, Kodgule R. Risk factors and pathophysiology of chronic obstructive pulmonary disease (COPD). J Assoc Physicians India. 2012 Feb;60 Suppl:17-21. No abstract available.
- Background: PubMed 35279265Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.
- Background: PubMed 33573386Kamal R, Srivastava AK, Kesavachandran CN, Bihari V, Singh A. Chronic obstructive pulmonary disease (COPD) in women due to indoor biomass burning: a meta analysis. Int J Environ Health Res. 2022 Jun;32(6):1403-1417. doi: 10.1080/09603123.2021.1887460. Epub 2021 Feb 12.
- Background: PubMed 35208563Rajnoveanu AG, Rajnoveanu RM, Motoc NS, Postolache P, Gusetu G, Man MA. COPD in Firefighters: A Specific Event-Related Condition Rather than a Common Occupational Respiratory Disorder. Medicina (Kaunas). 2022 Feb 5;58(2):239. doi: 10.3390/medicina58020239.
- Background: PubMed 12740290Halbert RJ, Isonaka S, George D, Iqbal A. Interpreting COPD prevalence estimates: what is the true burden of disease? Chest. 2003 May;123(5):1684-92. doi: 10.1378/chest.123.5.1684.
- Background: PubMed 35221161Medrinal C, Bonnevie T. [Physiotherapy during and after acute exacerbation of COPD]. Rev Mal Respir. 2022 Apr;39(4):386-397. doi: 10.1016/j.rmr.2022.02.056. Epub 2022 Feb 24. French.
- BackgroundMansha H, Rashid S, Khalid MU, Khan RR, Hassan M, Khalid H. Effects of Active Cycle of Breathing Techniques on quality of life in patients with Chronic Bronchitis. Foundation University Journal of Rehabilitation Sciences. 2022;2(2):40-5.
- Background: PubMed 30827317Liu H, Zhang X, Zhang Y. [Design and application of a pulmonary function exercise bottle]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2019 Feb;31(2):236-237. doi: 10.3760/cma.j.issn.2095-4352.2019.02.023. Chinese.
- Background: PubMed 35235877Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27.
- BackgroundHichkad S, Ganesh B. Effect of blow bottle device and flutter on functional capacity, dyspnea, fatigue, and peak expiratory flow rate in mild-to-moderate COPD patients: A comparative study. Indian Journal of Respiratory Care. 2021;10(3):294.
- 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.
Wajeeha Zia, phd* 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 BLOW BOTTLE and ACBT in people with COPD, 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 3 Jan 2024. 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.amjab@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness, Cough and Sputum Scale (BCSS). (time frame: 5thy day). 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 NCT06189196, which also lists 17 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 3 Jan 2024.