Chronic Obstructive Pulmonary DiseaseNCT04241510
Effects of Kinesio Taping Techniques in COPD Patients
A study testing Kinesio Taping in people with Chronic Obstructive Pulmonary Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Study will investigate effects of two different kinesio taping techniques on pulmonary parameters of patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Kinesio Taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 31 Oct 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female COPD patients aged between 40-80 years
- Diagnosed with COPD stage I-II-III-IV according to GOLD 2019 criterias
- Able to speak, understand and read Turkish language
- Volunteering to participate in study
Who cannot join
- Unstable or acutely exacerbated patients with COPD
- Alterations in medical treatment in last 6 months
- Having comorbidities that affect directly cardiopulmonary system, uncontrolled arterial hypertension, severe congestive heart failure, coronary arterial disease, heart valve disease
- Orthopaedic, neurological, psychiatric disease, peripheral/central nervous system diseases, mental retardation, antidepressants usage, metabolic impairments, malignancy
- Unable to cooperate for measurement and treatment techniques used in study
- Irritation, infection, allergic reaction, scarred burn or open wound around application area
Show all 9Show fewer
- Enrolled in a comprehensive pulmonary rehabilitation program before study
- Application of Kinesio Tape to any body region in the past
- History of an open heart surgery or other thoracic surgeries
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University Training and Research Hospital
Muğla, Menteşe, 48000
About this study
Official title: Effects of Kinesio Taping Techniques on Pulmonary Parameters and Functional Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease
Study will investigate effects of two different kinesio taping techniques on pulmonary parameters of patients with COPD.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an irreversible, progressive, treatable airway disease which causes dyspnea, wheezing, coughing and increased secretions in airways. Thoracic and respiratory mechanics are impaired, respiratory muscle strength and functional exercise capacity is decreased in patients with COPD. As a result dyspnea, limitation in activities of daily living, postural impairments, muscle length-strength relationship changes and increased mechanical loads on respiratory muscles occur. In literature it has been demonstrated that Kinesio Taping have therapeutic effects on respiratory functions and functional exercise capacity in patients with chronic neurological diseases who has additional respiratory impairments. Although there are several studies in literature investigating the effects of facilitation and inhibition taping techniques applied on respiratory muscles in patients with COPD, effects of thoracic and postural mechanical correction techniques as an alternative treatment modality in patients with COPD have not been investigated yet. In present study, effects of thoracic mechanical correction and facilitation taping techniques in patients with COPD will be investigated, and data will be collected for effects of thoracic mechanical correction taping on pulmonary parameters in patients with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Kinesio Taping
- Keywords
- Chronic Obstructive Pulmonary Disease, Mechanical Correction, Facilitation, Thoracic Taping, Kinesio Taping, Respiratory Muscle Strength, Pulmonary Functions, Functional Exercise Capacity
- 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.
Kinesio TapingDevice
Kinesio Taping is a special taping method developed by Dr. Kenzo Kase in 1973. This technique triggers natural healing responses of human body by activating nervous and circulatory systems. The tapes are thin, latex-free, cotton, porous and anti-allergenic, with equal thickness of epidermis. It has elastic properites which allows the tape to elongate to %55-60 of its original lenght. Tape can be used up to 1 week even after sweating or cleaning with water. There are different application techniques for different purposes. Facilitation technique facilitates muscle contractions and supports muscle function. Mechancial correction technique is used for joint positioning and correcting motion of muscle-joint dynamics.
| Study group | Role | What they receive |
|---|---|---|
| Facilitation Tape | Active comparator | Diaphragm and Intercostal muscles will be taped with facilitation technique. After 30 minutes of application patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea. Receives: Device: Kinesio Taping |
| Mechanical Correction Tape | Active comparator | Thorax will be taped with mechanical correction technique. After 30 minutes of application patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea. Receives: Device: Kinesio Taping |
| No Tape | No intervention | Patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea with no tape. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test
Pulmonary functions will be evaulated in laboratory conditions. Dynamic lung volumes will be measured using standardized spirometric measurement regulations established by ATS/ERS guidelines.
Measured: 30 minutes after every application
Respiratory Muscle Strength
Respiratory muscle strenght will be measured as Maximum Inspiratory Pressure \& Maximum Expiratory Pressure with MicroMPM device. Measuring procedure will be held according to ERS guidelines. Measurements will be interpreted with Black and Hyatt's references.
Measured: 30 minutes after every application
Functional Exercise Capacity
Functional exercise capacity will be measured with 6-minute walk test. Cardiovascular paremeters, dyspnea, respiratory rate and fatigue will be evaulated before, during and after the test .
Measured: 30 minutes after every application
Dyspnea
Dyspnea in daily living was evaluated by the Modified Medical Research Council Dyspnea Scale. The scale consists in five statements that describe almost the entire range of dyspnea from none (Grade 0) to almost complete incapacity (Grade 4). Higher scores indicates increased dyspnea perception.
Measured: 30 minutes after each application
Secondary outcomes (1)
Perception of Disease
COPD Assesment Test (CAT) will be used to evaulate patients perception of symptoms.
Measured: 30 minutes after each application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Apr 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Crossover
- Model description
- Prospective, Double-Blinded, Randomized Crossover Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Camcıoğlu Yılmaz, Muğla Sıtkı Koçman University
- Investigators
- Burcu Camcıoğlu Yılmaz, PT, PhD, Study director, Muğla Sıtkı Koçman UniversityMetehan Sarıkaya, MSc. Student, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241510
- Sponsor's protocol ID
- KPR1
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Global Initiative for Chronic Obstructive Lung Disease (2019 Report). 2019;2-14
Orozco-Levi M. Structure and function of the respiratory muscles in patients with COPD: impairment or adaptation? Eur Respir J Suppl. 2003 Nov;46:41s-51s. doi: 10.1183/09031936.03.00004607.
PubMed 14621106Kaneko H, Shiranita S, Horie J, Hayashi S. Reduced Chest and Abdominal Wall Mobility and Their Relationship to Lung Function, Respiratory Muscle Strength, and Exercise Tolerance in Subjects With COPD. Respir Care. 2016 Nov;61(11):1472-1480. doi: 10.4187/respcare.04742. Epub 2016 Oct 18.
PubMed 27794081Kenso Kase, Jim Wallis, Tsuyoshi Kase - Clinical Therapeutic Application Kinesio® Taping Manual. 2nd ed. Kinesio; 2003. 12-39 p.
Kase K. Kenzo Kase. - Illustrated Kinesio Taping. In: 4th ed. p. 6-12, 72-5.
American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Rostagno C, Gensini GF. Six minute walk test: a simple and useful test to evaluate functional capacity in patients with heart failure. Intern Emerg Med. 2008 Sep;3(3):205-12. doi: 10.1007/s11739-008-0130-6. Epub 2008 Feb 26.
PubMed 18299800Cheng SL, Lin CH, Wang CC, Chan MC, Hsu JY, Hang LW, Perng DW, Yu CJ, Wang HC; Taiwan Clinical Trial Consortium for Respiratory Disease (TCORE). Comparison between COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) dyspnea scores for evaluation of clinical symptoms, comorbidities and medical resources utilization in COPD patients. J Formos Med Assoc. 2019 Jan;118(1 Pt 3):429-435. doi: 10.1016/j.jfma.2018.06.018. Epub 2018 Aug 25.
PubMed 30150099Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
PubMed 17507545Yorgancioglu A, Polatli M, Aydemir O, Yilmaz Demirci N, Kirkil G, Nayci Atis S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Reliability and validity of Turkish version of COPD assessment test]. Tuberk Toraks. 2012;60(4):314-20. doi: 10.5578/tt.4321. Turkish.
PubMed 23289460Kinesio Tape® Applied to the Thorax Augments Ventilatory Efficiency during Heavy Exercise. Int J Exerc Sci. 2013;6(2):8.
Metin Okmen B, Sengoren Dikis O, Okmen K, Altan L, Yildiz T. Investigation of the effect of kinesiotaping on the respiratory function and depression in male patients with chronic obstructive pulmonary disease: a prospective, randomized, controlled, and single-blind study. Aging Male. 2020 Dec;23(5):648-654. doi: 10.1080/13685538.2019.1567703. Epub 2019 Feb 10.
PubMed 30739540Aydoğan Arslan S, Daşkapan AD, Özünlü Pekyavaş N, Sakızlı E. Effects of Kinesio Taping Applied to Diaphragm Muscle on Aerobic Exercise Capacity and Pulmonary Function in Sedentary Individuals. Anadolu Klin Tıp Bilim Derg. 2018;23(2):68-72.
Zübeyir S, Nilüfer K, Burcu C, Onur A, Bahar K, Ufuk YS, et al. The Effect of Kinesiology Taping on Respiratory Muscle Strength. J Phys Ther Sci. 2012;24(3):241-4.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping Techniques on Pulmonary Parameters and Functional Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04241510
- Acronym / sponsor ID
- KPR1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Mechanical Correction, Facilitation, Thoracic Taping, Kinesio Taping, Respiratory Muscle Strength, Pulmonary Functions, Functional Exercise Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 27 Jan 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.
Study will investigate effects of two different kinesio taping techniques on pulmonary parameters of patients with COPD.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an irreversible, progressive, treatable airway disease which causes dyspnea, wheezing, coughing and increased secretions in airways. Thoracic and respiratory mechanics are impaired, respiratory muscle strength and functional exercise capacity is decreased in patients with COPD. As a result dyspnea, limitation in activities of daily living, postural impairments, muscle length-strength relationship changes and increased mechanical loads on respiratory muscles occur. In literature it has been demonstrated that Kinesio Taping have therapeutic effects on respiratory functions and functional exercise capacity in patients with chronic neurological diseases who has additional respiratory impairments. Although there are several studies in literature investigating the effects of facilitation and inhibition taping techniques applied on respiratory muscles in patients with COPD, effects of thoracic and postural mechanical correction techniques as an alternative treatment modality in patients with COPD have not been investigated yet. In present study, effects of thoracic mechanical correction and facilitation taping techniques in patients with COPD will be investigated, and data will be collected for effects of thoracic mechanical correction taping on pulmonary parameters in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, Double-Blinded, Randomized Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Facilitation Tape | Active comparator | Device: Kinesio TapingDiaphragm and Intercostal muscles will be taped with facilitation technique. After 30 minutes of application patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea. |
| Mechanical Correction Tape | Active comparator | Device: Kinesio TapingThorax will be taped with mechanical correction technique. After 30 minutes of application patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea. |
| No Tape | No intervention | –Patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea with no tape. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female COPD patients aged between 40-80 years
- Diagnosed with COPD stage I-II-III-IV according to GOLD 2019 criterias
- Able to speak, understand and read Turkish language
- Volunteering to participate in study
Key exclusion criteria (9 listed)
- Unstable or acutely exacerbated patients with COPD
- Alterations in medical treatment in last 6 months
- Having comorbidities that affect directly cardiopulmonary system, uncontrolled arterial hypertension, severe congestive heart failure, coronary arterial disease, heart valve disease
- Orthopaedic, neurological, psychiatric disease, peripheral/central nervous system diseases, mental retardation, antidepressants usage, metabolic impairments, malignancy
- Unable to cooperate for measurement and treatment techniques used in study
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 |
|---|---|---|
| Kinesio TapingKinesio Taping is a special taping method developed by Dr. Kenzo Kase in 1973. This technique triggers natural healing responses of human body by activating nervous and circulatory systems. The tapes are thin, latex-free, cotton, porous and anti-allergenic, with equal thickness of epidermis. It has elastic properites which allows the tape to elongate to %55-60 of its original lenght. Tape can be used up to 1 week even after sweating or cleaning with water. There are different application techniques for different purposes. Facilitation technique facilitates muscle contractions and supports muscle function. Mechancial correction technique is used for joint positioning and correcting motion of muscle-joint dynamics. | Device | Facilitation Tape, Mechanical Correction Tape |
Primary outcome
Pulmonary Function Test
Time frame: 30 minutes after every application
Pulmonary functions will be evaulated in laboratory conditions. Dynamic lung volumes will be measured using standardized spirometric measurement regulations established by ATS/ERS guidelines.
Respiratory Muscle Strength
Time frame: 30 minutes after every application
Respiratory muscle strenght will be measured as Maximum Inspiratory Pressure \& Maximum Expiratory Pressure with MicroMPM device. Measuring procedure will be held according to ERS guidelines. Measurements will be interpreted with Black and Hyatt's references.
Functional Exercise Capacity
Time frame: 30 minutes after every application
Functional exercise capacity will be measured with 6-minute walk test. Cardiovascular paremeters, dyspnea, respiratory rate and fatigue will be evaulated before, during and after the test .
Dyspnea
Time frame: 30 minutes after each application
Dyspnea in daily living was evaluated by the Modified Medical Research Council Dyspnea Scale. The scale consists in five statements that describe almost the entire range of dyspnea from none (Grade 0) to almost complete incapacity (Grade 4). Higher scores indicates increased dyspnea perception.
1 secondary outcome
Perception of Disease
Time frame: 30 minutes after each application.
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 1 Nov 2022.
- BackgroundGlobal Initiative for Chronic Obstructive Lung Disease (2019 Report). 2019;2-14
- Background: PubMed 14621106Orozco-Levi M. Structure and function of the respiratory muscles in patients with COPD: impairment or adaptation? Eur Respir J Suppl. 2003 Nov;46:41s-51s. doi: 10.1183/09031936.03.00004607.
- Background: PubMed 27794081Kaneko H, Shiranita S, Horie J, Hayashi S. Reduced Chest and Abdominal Wall Mobility and Their Relationship to Lung Function, Respiratory Muscle Strength, and Exercise Tolerance in Subjects With COPD. Respir Care. 2016 Nov;61(11):1472-1480. doi: 10.4187/respcare.04742. Epub 2016 Oct 18.
- BackgroundKenso Kase, Jim Wallis, Tsuyoshi Kase - Clinical Therapeutic Application Kinesio® Taping Manual. 2nd ed. Kinesio; 2003. 12-39 p.
- BackgroundKase K. Kenzo Kase. - Illustrated Kinesio Taping. In: 4th ed. p. 6-12, 72-5.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 18299800Rostagno C, Gensini GF. Six minute walk test: a simple and useful test to evaluate functional capacity in patients with heart failure. Intern Emerg Med. 2008 Sep;3(3):205-12. doi: 10.1007/s11739-008-0130-6. Epub 2008 Feb 26.
- Background: PubMed 30150099Cheng SL, Lin CH, Wang CC, Chan MC, Hsu JY, Hang LW, Perng DW, Yu CJ, Wang HC; Taiwan Clinical Trial Consortium for Respiratory Disease (TCORE). Comparison between COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) dyspnea scores for evaluation of clinical symptoms, comorbidities and medical resources utilization in COPD patients. J Formos Med Assoc. 2019 Jan;118(1 Pt 3):429-435. doi: 10.1016/j.jfma.2018.06.018. Epub 2018 Aug 25.
- Background: PubMed 17507545Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
- Background: PubMed 23289460Yorgancioglu A, Polatli M, Aydemir O, Yilmaz Demirci N, Kirkil G, Nayci Atis S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Reliability and validity of Turkish version of COPD assessment test]. Tuberk Toraks. 2012;60(4):314-20. doi: 10.5578/tt.4321. Turkish.
- Results publicationKinesio Tape® Applied to the Thorax Augments Ventilatory Efficiency during Heavy Exercise. Int J Exerc Sci. 2013;6(2):8.
- 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.
Burcu Camcıoğlu Yılmaz, PT, PhD study director
Muğla Sıtkı Koçman University
Metehan Sarıkaya, MSc. Student principal investigator
Muğla Sıtkı Koçman 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 Kinesio Taping in people with Chronic Obstructive Pulmonary Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 9 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 1 Nov 2022. 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 Turkey (Türkiye). 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?
Pulmonary Function Test (time frame: 30 minutes after every application). The study lists 4 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 NCT04241510, which also lists 23 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 1 Nov 2022.