COPDNCT04357743
Pursed Lip Breathing With Arm Ergometry After Chin Supported Position in COPD Patients.
A study testing Chin supported Arm ergometry with pursed lip breathing and Arm ergometry with pursed lip breathing in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
Randomized control Trial, Purposive sampling was used to obtain the sample for the study and then randomly allocated into groups by coin toss method. Data collected from July 2019 to January 2020, was conducted at Rehman Medical Institute Peshawar. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Chin supported Arm ergometry with pursed lip breathing and Arm ergometry with pursed lip breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2019to 10 Feb 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate stage COPD according to GOLD criteria {i-e Global Initiative for Obstructive Lung Disease (GOLD) }
Who cannot join
- COPD patient with angina pectoris,
- third degree heart block,
- congestive heart failure and
- orthopedic or neuromuscular conditions (cervical involvement which aggravate symptoms) or radiculopathy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Pulmonology of Rehman medical Institute.
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Effects of Pursed Lip Breathing With Arm Ergometry After Chin Supported Position in COPD Patients.
Randomized control Trial, Purposive sampling was used to obtain the sample for the study and then randomly allocated into groups by coin toss method. Data collected from July 2019 to January 2020, was conducted at Rehman Medical Institute Peshawar. To determine the effects of pursed lip breathing with arm ergometry after chin support position on heart rate, respiratory parameters, pulmonary function tests and quality of life in COPD patients.
Read the detailed description
Chronic Obstructive Lung Disease (COPD), a major worldwide epidemic is the 4th leading cause of death around the globe and though, with rise in worldwide life expectancy and tobacco smoking, predominantly in developing countries, it is likely to be the 3rd leading cause of mortality by 2020. In Pakistan, mortality rate caused by COPD is expected to reach 71 deaths per 100,000 that is globally the fourth leading death rate among 25 most populated countries.
The condition is in the focus worldwide, since its increased prevalence, morbidity and mortality rate create alarming challenges for health-care professionals. In spite of latest trends in decline of COPD consistent death rates and few current achievements in anti-smoking efforts in many western countries, the elevating influence of increasing age in an ever-growing global population, combined with factors as high smoking rates and pollution of air in Asia, will confirm that COPD will last as an ever-increasing issue into the 21st century.
A variety of environmental and intrinsic risk factors are involved in the development of COPD which affect at different time points during an individual's life span. Smoking is a dominant risk factor comprising of 80% of the COPD cases.
During the previous 5 years, an exceeding quantity of risk factors excluding smoking have been associated with the COPD development, predominantly in developing countries.
Exercise intolerance is a challenging result of COPD and often happens during arm activities. . Exercise intolerance can be best described by the concept of dynamic hyperinflation. The thoracic motion is regulated due to hyperinflation and thus capacity to increase tidal volume during exercise is limited. Many research studies have established that there is limited arm exercise capacity, and patients often complain of notable dyspnea and fatigue during arm activities essential in daily life. Two mechanisms have been recommended: neuro-mechanical dysfunction of respiratory musculature, that are diaphragm and accessory respiratory muscles, thoracic-abdominal asynchronous and changes in lung volume during upper limb activities. Impairments in ventilatory mechanics in COPD patients result in termination of arm exercises at lower workloads compared with healthy subjects.
When these patients were asked to open their mouths to breathe out instead of using pursed lips Breathing (PLB) they immediately developed severe dyspnea and suffocation. The term PLB was utilized as the patients had lips almost completely sealed while they were exhaling. However, the term pursed lip or puckered lip breathing was not well characterized, and the techniques taught to patients varied depending on the clinician. PLB was defined as a self-induced type of positive-pressure breath. One definition given by Wikipedia, is that PLB is a breathing technique that consists of exhaling through tightly pressed lip (pursed lips) and inhaling through nose with mouth closed. The "tightly" is the word that can be subjective and open to interpretation. The online free medical dictionary gives a very similar definition as Wikipedia; however, it removed "tightly" from the "tightly pursed lip". Regardless of "tightly pursed lip" vs. "pressed lip", the purpose of this breathing is to slow down the air flow during the exhalation to build up back pressure in the airway to avoid a sudden drop in intra-pulmonary pressure resulting in alveolar and airway collapse. Pursed lip breathing, is a strategic breathing training often used by COPD patients to obtain relief from dyspnea.
A shift in the pattern of recruitment of inspiratory and expiratory muscles with PLB exercise. There is a better activity in the rib cage and accessory muscles than with activity of diaphragm. The diaphragmatic tension-time index is decreased. Consequently, PLB by altering recruitment pattern decreases the possibility of fatigue of diaphragm and improves breathlessness. It also upsurges recruitment of abdominal expiratory musculature. Expiratory muscle recruitment does not only ease expiration but also aids in inspiration by developing the length-tension relationship of the inspiratory muscles.
Body positioning is one of the controlled breathing maneuvers to improve the respiratory muscle functioning and decreasing dyspnea. That is why the COPD patients often assume the tripod position, which is, sitting with forward lean of trunk and arm support, during breathlessness. This position develops the length-tension relationship of diaphragm and decreases the activity of sternocleidomastoid and scalene muscles thus improving thoraco-abdominal movement and reducing breathlessness. The arm support in this position recruits pectoralis major and pectoralis minor musculature to improve rib elevation
- Conditions
- COPD
- Being tested
- Chin supported Arm ergometry with pursed lip breathing, Arm ergometry with pursed lip breathing
- Keywords
- Arm Ergometry, Chin Support Position, Oxygen Saturation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chin supported Arm ergometry with pursed lip breathingOther
The participants sat in chin support position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes. The participants again sat in chin support position for 10 minutes.
The treatment was provided for one week
Arm ergometry with pursed lip breathingOther
The participants sat in normal position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes; the participants again sat in sitting position for 10 minutes.
The treatment was provided for one week.
| Study group | Role | What they receive |
|---|---|---|
| Chin supported Arm ergometry with pursed lip breathing | Experimental | Chin supported along with Arm ergometry with pursed lip breathing Receives: Other: Chin supported Arm ergometry with pursed lip breathing |
| Arm ergometry with pursed lip breathing | Active comparator | Arm ergometry with pursed lip breathing Receives: Other: Arm ergometry with pursed lip breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Measured: 1 week
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Measured: 1 week
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Measured: 1 week
Oxygen Saturation (SpO2)
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Measured: 1 week
Pulse Rate/Heart Rate
Changes from the Baseline, It is the speed of Pulse/heart contractions per minute. It is measured by pulse oximeter
Measured: 1 week
Modified Borg Scale of Perceived Exertion
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Measured: 1 week
Secondary outcomes (1)
COPD Assessment Tool (CAT)
Changes from the baseline, CAT is a tool to assess the burden in COPD and is not a diagnostic tool. It is recommended by GOLD guidelines 2018. It is an eight item questionnaire with a scoring range of 0 to 40. It is categorized into four groups, that are, low(1) , medium(2), high(3) and very high(4) based on the level of effect of the disease on status of health. CAT has reliability of 0.85 to 0.98
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Apr 2019
- Primary completion10 Jan 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MsCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357743
- Sponsor's protocol ID
- REC/00591 Mashaal Rana
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tunkamnerdthai O, Auvichayapat P, Punjaruk W, Manimmanakorn A, Leelayuwat N, Boonsawat W, et al. Modified Arm Swing Exercise Improves Oxidative Stress and Heart Rate Variability in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Journal of Exercise Physiology Online. 2018;21(4)
Halldin CN, Doney BC, Hnizdo E. Changes in prevalence of chronic obstructive pulmonary disease and asthma in the US population and associated risk factors. Chron Respir Dis. 2015 Feb;12(1):47-60. doi: 10.1177/1479972314562409. Epub 2014 Dec 24.
PubMed 25540134Ntritsos G, Franek J, Belbasis L, Christou MA, Markozannes G, Altman P, Fogel R, Sayre T, Ntzani EE, Evangelou E. Gender-specific estimates of COPD prevalence: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 May 10;13:1507-1514. doi: 10.2147/COPD.S146390. eCollection 2018.
PubMed 29785100Mesquita Montes A, Maia J, Crasto C, de Melo CA, Carvalho P, Santos R, Pereira S, Vilas-Boas JP. Abdominal muscle activity during breathing in different postures in COPD "Stage 0" and healthy subjects. Respir Physiol Neurobiol. 2017 Apr;238:14-22. doi: 10.1016/j.resp.2017.01.001. Epub 2017 Jan 7.
PubMed 28082171Xu J, He S, Han Y, Pan J, Cao L. Effects of modified pulmonary rehabilitation on patients with moderate to severe chronic obstructive pulmonary disease: A randomized controlled trail. Int J Nurs Sci. 2017 Jun 27;4(3):219-224. doi: 10.1016/j.ijnss.2017.06.011. eCollection 2017 Jul 10.
PubMed 31406744McCarthy 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 25705944Bharadwaj TA, Jiandani MP, Mehta A. PURSED LIP BREATHING INCREASES UNSUPPORTED UPPER EXTREMITY EXERCISE ENDURANCE AND REDUCES DESATURATION IN COPD. Romanian Journal of Physical Therapy/Revista Romana de Kinetoterapie. 2016;21(38).
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pursed Lip Breathing With Arm Ergometry After Chin Supported Position in COPD Patients.
- ClinicalTrials.gov ID
- NCT04357743
- Acronym / sponsor ID
- REC/00591 Mashaal Rana
- Conditions
- COPD
- Keywords
- Arm Ergometry, Chin Support Position, Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 22 Apr 2020 (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.
Randomized control Trial, Purposive sampling was used to obtain the sample for the study and then randomly allocated into groups by coin toss method. Data collected from July 2019 to January 2020, was conducted at Rehman Medical Institute Peshawar. To determine the effects of pursed lip breathing with arm ergometry after chin support position on heart rate, respiratory parameters, pulmonary function tests and quality of life in COPD patients.
Detailed description
Chronic Obstructive Lung Disease (COPD), a major worldwide epidemic is the 4th leading cause of death around the globe and though, with rise in worldwide life expectancy and tobacco smoking, predominantly in developing countries, it is likely to be the 3rd leading cause of mortality by 2020. In Pakistan, mortality rate caused by COPD is expected to reach 71 deaths per 100,000 that is globally the fourth leading death rate among 25 most populated countries.
The condition is in the focus worldwide, since its increased prevalence, morbidity and mortality rate create alarming challenges for health-care professionals. In spite of latest trends in decline of COPD consistent death rates and few current achievements in anti-smoking efforts in many western countries, the elevating influence of increasing age in an ever-growing global population, combined with factors as high smoking rates and pollution of air in Asia, will confirm that COPD will last as an ever-increasing issue into the 21st century.
A variety of environmental and intrinsic risk factors are involved in the development of COPD which affect at different time points during an individual's life span. Smoking is a dominant risk factor comprising of 80% of the COPD cases.
During the previous 5 years, an exceeding quantity of risk factors excluding smoking have been associated with the COPD development, predominantly in developing countries.
Exercise intolerance is a challenging result of COPD and often happens during arm activities. . Exercise intolerance can be best described by the concept of dynamic hyperinflation. The thoracic motion is regulated due to hyperinflation and thus capacity to increase tidal volume during exercise is limited. Many research studies have established that there is limited arm exercise capacity, and patients often complain of notable dyspnea and fatigue during arm activities essential in daily life. Two mechanisms have been recommended: neuro-mechanical dysfunction of respiratory musculature, that are diaphragm and accessory respiratory muscles, thoracic-abdominal asynchronous and changes in lung volume during upper limb activities. Impairments in ventilatory mechanics in COPD patients result in termination of arm exercises at lower workloads compared with healthy subjects.
When these patients were asked to open their mouths to breathe out instead of using pursed lips Breathing (PLB) they immediately developed severe dyspnea and suffocation. The term PLB was utilized as the patients had lips almost completely sealed while they were exhaling. However, the term pursed lip or puckered lip breathing was not well characterized, and the techniques taught to patients varied depending on the clinician. PLB was defined as a self-induced type of positive-pressure breath. One definition given by Wikipedia, is that PLB is a breathing technique that consists of exhaling through tightly pressed lip (pursed lips) and inhaling through nose with mouth closed. The "tightly" is the word that can be subjective and open to interpretation. The online free medical dictionary gives a very similar definition as Wikipedia; however, it removed "tightly" from the "tightly pursed lip". Regardless of "tightly pursed lip" vs. "pressed lip", the purpose of this breathing is to slow down the air flow during the exhalation to build up back pressure in the airway to avoid a sudden drop in intra-pulmonary pressure resulting in alveolar and airway collapse. Pursed lip breathing, is a strategic breathing training often used by COPD patients to obtain relief from dyspnea.
A shift in the pattern of recruitment of inspiratory and expiratory muscles with PLB exercise. There is a better activity in the rib cage and accessory muscles than with activity of diaphragm. The diaphragmatic tension-time index is decreased. Consequently, PLB by altering recruitment pattern decreases the possibility of fatigue of diaphragm and improves breathlessness. It also upsurges recruitment of abdominal expiratory musculature. Expiratory muscle recruitment does not only ease expiration but also aids in inspiration by developing the length-tension relationship of the inspiratory muscles.
Body positioning is one of the controlled breathing maneuvers to improve the respiratory muscle functioning and decreasing dyspnea. That is why the COPD patients often assume the tripod position, which is, sitting with forward lean of trunk and arm support, during breathlessness. This position develops the length-tension relationship of diaphragm and decreases the activity of sternocleidomastoid and scalene muscles thus improving thoraco-abdominal movement and reducing breathlessness. The arm support in this position recruits pectoralis major and pectoralis minor musculature to improve rib elevation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chin supported Arm ergometry with pursed lip breathing | Experimental | Other: Chin supported Arm ergometry with pursed lip breathingChin supported along with Arm ergometry with pursed lip breathing |
| Arm ergometry with pursed lip breathing | Active comparator | Other: Arm ergometry with pursed lip breathingArm ergometry with pursed lip breathing |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate stage COPD according to GOLD criteria {i-e Global Initiative for Obstructive Lung Disease (GOLD) }
Key exclusion criteria (4 listed)
- COPD patient with angina pectoris,
- third degree heart block,
- congestive heart failure and
- orthopedic or neuromuscular conditions (cervical involvement which aggravate symptoms) or radiculopathy
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 |
|---|---|---|
| Chin supported Arm ergometry with pursed lip breathingThe participants sat in chin support position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes. The participants again sat in chin support position for 10 minutes. The treatment was provided for one week | Other | Chin supported Arm ergometry with pursed lip breathing |
| Arm ergometry with pursed lip breathingThe participants sat in normal position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes; the participants again sat in sitting position for 10 minutes. The treatment was provided for one week. | Other | Arm ergometry with pursed lip breathing |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 1 week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 1 week
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Peak Expiratory Flow (PEF)
Time frame: 1 week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Oxygen Saturation (SpO2)
Time frame: 1 week
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Pulse Rate/Heart Rate
Time frame: 1 week
Changes from the Baseline, It is the speed of Pulse/heart contractions per minute. It is measured by pulse oximeter
Modified Borg Scale of Perceived Exertion
Time frame: 1 week
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
1 secondary outcome
COPD Assessment Tool (CAT)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- BackgroundTunkamnerdthai O, Auvichayapat P, Punjaruk W, Manimmanakorn A, Leelayuwat N, Boonsawat W, et al. Modified Arm Swing Exercise Improves Oxidative Stress and Heart Rate Variability in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Journal of Exercise Physiology Online. 2018;21(4)
- Background: PubMed 25540134Halldin CN, Doney BC, Hnizdo E. Changes in prevalence of chronic obstructive pulmonary disease and asthma in the US population and associated risk factors. Chron Respir Dis. 2015 Feb;12(1):47-60. doi: 10.1177/1479972314562409. Epub 2014 Dec 24.
- Background: PubMed 29785100Ntritsos G, Franek J, Belbasis L, Christou MA, Markozannes G, Altman P, Fogel R, Sayre T, Ntzani EE, Evangelou E. Gender-specific estimates of COPD prevalence: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 May 10;13:1507-1514. doi: 10.2147/COPD.S146390. eCollection 2018.
- Background: PubMed 28082171Mesquita Montes A, Maia J, Crasto C, de Melo CA, Carvalho P, Santos R, Pereira S, Vilas-Boas JP. Abdominal muscle activity during breathing in different postures in COPD "Stage 0" and healthy subjects. Respir Physiol Neurobiol. 2017 Apr;238:14-22. doi: 10.1016/j.resp.2017.01.001. Epub 2017 Jan 7.
- Background: PubMed 31406744Xu J, He S, Han Y, Pan J, Cao L. Effects of modified pulmonary rehabilitation on patients with moderate to severe chronic obstructive pulmonary disease: A randomized controlled trail. Int J Nurs Sci. 2017 Jun 27;4(3):219-224. doi: 10.1016/j.ijnss.2017.06.011. eCollection 2017 Jul 10.
- 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.
- BackgroundBharadwaj TA, Jiandani MP, Mehta A. PURSED LIP BREATHING INCREASES UNSUPPORTED UPPER EXTREMITY EXERCISE ENDURANCE AND REDUCES DESATURATION IN COPD. Romanian Journal of Physical Therapy/Revista Romana de Kinetoterapie. 2016;21(38).
- 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.
Iqbal Tariq, MsCPPT 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 Chin supported Arm ergometry with pursed lip breathing and Arm ergometry with pursed lip breathing 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 1 inclusion and 4 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 22 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: 1 week). 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 NCT04357743, which also lists 7 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 22 Apr 2020.