Respiratory System DiseasePhase 3NCT05299385
The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)
A Phase 3 study testing Conventional rehabilition treatment(e.g leaflet) educated by hospital and Digital treatment based on Respiratory Rehabilitation Software in people with Respiratory System Disease and Chronic Obstructive Pulmonary Disease, run by Lifesemantics Corp. at 3 sites in South Korea.
Trial summary
The purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software, compared to the manual rehabilitation management for those who need respiratory rehabilitation(COPD, Asthma, Lung… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Respiratory System Disease, Chronic Obstructive Pulmonary Disease, Asthma Copd
- What is being tested?
- Conventional rehabilition treatment(e.g leaflet) educated by hospital and Digital treatment based on Respiratory Rehabilitation Software
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 13 Jan 2022to 30 Jun 2022
- Phase
- Phase 3
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 to 80 years-old
- Subject who has difficulty in respiratory symptoms and routine with the criteria as below 1) mMRC(modified Medical Research Council Dyspnea Scale) 1 point at least 2) In accordance with Pulmonary function test(PFT/LET/EEG) examined, if there is in one of the following cases as below [a lung cancer patient] (FVC or FEV1 < 80%), [No lung cancer patient] (Post-bronchodilator FEV1/FVC < 0.7) and (Post-bronchodilator FEV1 < 80%)
- Subject with an Android smartphone (OS 8.0 or higher, internal memory (HDD) of 32GB or higher) or iPhone (iOS 13.0 or higher, internal memory (HDD of 32GB or higher)
- Subject who can use effectively smartphone and mobile software
- Subject who brings their smartphone for a walking test during 12 weeks of the clinical trial.
- Subject who makes the decision voluntarily for participating in the clinical trial and to write their signature to the consent of subject's explanation.
- Subject who complies with the clinical protocol
Who cannot join
- Subject who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc.
- Subject who participate in respiratory rehabilitation treatment within 6 months of the screening date
- Subject who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
- Subject who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
- a pulmonary arterial hypertension subject
- Subject prescribed physical(e.g. lower-leg joint surgery, neurological limitation) or cognitive factors(e.g. psychical disorder)
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- Pregnant or lactating women
- Subject who is unable to read text and tough to communicate
- Subject who has participated in other clinical trials within 90 days of the screening date or participating in other clinical trials.
- Subject who is determined to inappropriate to perform this study according to clinical research associate's opinion(e.g if someone has a bearing on the result of the clinical trial ethically or clinically)
Trial locations and contacts
3 sites in 1 country.
Seiwon Lee contact
South Korea3 sites, 3 recruiting
- Recruiting
Kangwon National University Hospital
Chuncheon
- Recruiting
Asan Medical Center
Seoul
- Recruiting
Kangwon National University Hospital
Seoul
About this study
Official title: Multicenter, Prospective, Comparative, Randomized, Single Blind, Superior, Pivotal Study to Evaluate the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath' Compared to the Manual Rehabilitation Management(COPD, Asthma, Lung Cancer, Etc.)
The purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software, compared to the manual rehabilitation management for those who need respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.)
- Conditions
- Respiratory System Disease, Chronic Obstructive Pulmonary Disease, Asthma Copd, Lung Cancer, Lung Diseases, Pulmonary Rehabilitation
- Being tested
- Conventional rehabilition treatment(e.g leaflet) educated by hospital, Digital treatment based on Respiratory Rehabilitation Software
- Keywords
- DTx, Digital therapeutics, PR, COPD
- Medical subject headings
- Respiratory Tract Diseases, Pulmonary Disease, Chronic Obstructive, Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilition treatment(e.g leaflet) educated by hospitalBehavioural
Also called the conventional rehabilitation treatment
Active Comparator: subjects who are trained in accordance with the conventional manual treatment of Respiratory rehabilitation in the clinical institution and taking care home-based management.
The manual contents
- method of the conventional rehabilitation treatment
- intensity for aerobic exercise and anaerobic exercise
Digital treatment based on Respiratory Rehabilitation SoftwareDevice
Also called Respiratory Rehabilitation Software
Experimental: subjects who use the software as a home-based Digital Respiratory Rehabilitation software
It is intended for subjects who are prescribed a respiratory rehabilitation exercise to improve their physical condition. The software also helps them to do self-rehabilitation exercise.
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | The investigator provide conventional-treatment to subjects when distributing respiratory rehabilitation education leaflets, Investigators explain the leaflets and self-practice until the subjects fully understand them. Compactor conducts respiratory rehabilitation treatment for 12 weeks according to the following procedures at home
☞ The investigator shall contact the subject every two weeks during the respiratory rehabilitation period and encourage them to perform respiratory rehabilitation treatment according to the assigned group. Subjects perform respiratory rehabilitation exercises at home.
They have to visit hospital at 8 weeks (visit 3) and 12 weeks (visit 4) and then examine the factor of the outcome measure following the clinical protocol Receives: Behavioral: Conventional rehabilition treatment(e.g leaflet) educated by hospital |
| Experimental treatment | Experimental | Subjects install software as a medical device for clinical trials on smart-phones, so that the subject can perform respiratory rehabilitation treatment at home.
Respiratory rehabilitation treatment for 12 weeks
☞ Respiratory rehabilitation treatment using a mobile-based software, consists of aerobic exercise and anaerobic exercise, and the subject performs themselves
They have to visit hospital at 8 weeks (visit 3) and 12 weeks (visit 4) and then examine the factor of the outcome measure following the clinical protocol Receives: Device: Digital treatment based on Respiratory Rehabilitation Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 12 weeks after respiratory rehabilitation compared to the baseline.
the primary efficacy variable is the change of respiratory function parameters as a 6-minute walking distance(6MWT) in meters(m) at V4 compared with the baseline(V2). The value of 6MWD at V2 adjust as the value of covariate for statistical significance between the groups.
Measured: 12 weeks
Secondary outcomes (10)
The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 8 weeks after respiratory rehabilitation compared to the baseline.
the efficacy variable is the change of respiratory function parameters (6MWT) at V3 compared with the baseline(V2). Statistical significance is tested through the Independent two-sample-test or the Wilcoxon rank sum test. it will be evaluated separately from the primary outcome(6MWD at 12 weeks)
Measured: 8 weeks
The amount of change in the modified medical ressearch council Dyspnea scale (mMRC) scores at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
the efficacy variable is the change of respiratory function parameter by modified medical research council Dyspnea scale(mMRC) scores at V3 and V4 compared with the baseline(V2). the total score ranges from 0 to 4, The higher score means more severe symptoms. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.
Measured: 8 and 12 weeks
The amount of change in the Structures Respiratory Questionnaire (SGRQ) score at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
the efficacy variable is the change of respiratory function scores(Structures Respiratory Questionnaire, SGRQ) at V3 and V4 compared with the baseline(V2). Scores range from 0 to 100, with higher scores indicating more limitations. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.
Measured: 8 and 12 weeks
The amount of change in the Hospital Anxiety and Depression Scale (HADS) at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
the efficacy variable is the change of respiratory function scores(Hospital Anxiety and Depression Scale, HADS) at V3 and V4 compared with the baseline(V2). Scores range from 0 to 21, with the higher score indicating the more depressed and anxious. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.
Measured: 8 and 12 weeks
The amount of change in the average number of daily steps per week during the respiratory rehabilitation management period (number of times)
the efficacy variable is the daily step count detection using medical device for 12 weeks. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.
Measured: per week for 12weeks
The number of times in the use of medical support (days of hospitalization)
the efficacy variable is number of days of hospitalization for 12 weeks compared with the baseline(V2). Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.
Measured: 12 weeks
The number of times in the use of medical support (days of emergency room visits)
the efficacy variable is number of days of hospitalization, number of days of emergency room visits for 12 weeks compared with the baseline(V2). Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.
Measured: 12 weeks
Abnormal case (safety evaluation variable)
The analysis of abnormal case analyzes all abnormal cases(TEAE) that occurre after the application of medical devices for clinical trials.
Descriptive statistics(the number of subjects, incidence, and occurrence of coded adverse events) are presented by group. Treatment Emergency Adverse Event (TEAE), Adverse Device Effect (ADE), and Serious Adverse Event (SAE), and the difference in ratio between groups analyzes through Chi-square test or Fisher's exact test. The factors are coded according to SOC and PT using MedDRA. In addition, a detailed list is presented for individual subjects who have experienced significant abnormalities.
Measured: 8 and 12 weeks
Patient Global Assessment (PGA) evaluation for 12 weeks after respiratory rehabilitation management
the scores of experimental group's Patient Global Assessment (PGA) evaluation using medical device for 12 weeks. PGA is assessed by a single question ranged from 0 to 10. the higher score means the greater patient's satisfaction.
Measured: 12 weeks
Evaluation of the number of treatments during the respiratory rehabilitation management period (number of times)
the experimental group's the number of treatments, using medical device for 12 weeks represents descriptive statistics (number of subjects, average, standard deviation, median, minimum, and maximum value)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start13 Jan 2022
- Primary completion28 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory System 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifesemantics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center, KangWon National University Hospital, SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299385
- Sponsor's protocol ID
- LFSPMR-01
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung C, Kim DK, Lee JK, Heo EY, Kwon H, Kim D, Kim WJ, Lee SW. Smartphone App-Guided Pulmonary Rehabilitation in Chronic Respiratory Diseases: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Aug 25;13:e64884. doi: 10.2196/64884.
PubMed 40854157
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Comparative, Randomized, Single Blind, Superior, Pivotal Study to Evaluate the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath' Compared to the Manual Rehabilitation Management(COPD, Asthma, Lung Cancer, Etc.)
- ClinicalTrials.gov ID
- NCT05299385
- Acronym / sponsor ID
- LFSPMR-01
- Conditions
- Respiratory System Disease, Chronic Obstructive Pulmonary Disease, Asthma Copd, Lung Cancer, Lung Diseases, Pulmonary Rehabilitation
- Keywords
- DTx, Digital therapeutics, PR, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lifesemantics Corp.Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center, KangWon National University Hospital, SMG-SNU Boramae Medical Center
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 28 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 29 Mar 2022 (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 purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software, compared to the manual rehabilitation management for those who need respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Behavioral: Conventional rehabilition treatment(e.g leaflet) educated by hospitalThe investigator provide conventional-treatment to subjects when distributing respiratory rehabilitation education leaflets, Investigators explain the leaflets and self-practice until the subjects fully understand them. Compactor conducts respiratory rehabilitation treatment for 12 weeks according to the following procedures at home ☞ The investigator shall contact the subject every two weeks during the respiratory rehabilitation period and encourage them to perform respiratory rehabilitation treatment according to the assigned group. Subjects perform respiratory rehabilitation exercises at home. They have to visit hospital at 8 weeks (visit 3) and 12 weeks (visit 4) and then examine the factor of the outcome measure following the clinical protocol |
| Experimental treatment | Experimental | Device: Digital treatment based on Respiratory Rehabilitation SoftwareSubjects install software as a medical device for clinical trials on smart-phones, so that the subject can perform respiratory rehabilitation treatment at home. Respiratory rehabilitation treatment for 12 weeks ☞ Respiratory rehabilitation treatment using a mobile-based software, consists of aerobic exercise and anaerobic exercise, and the subject performs themselves They have to visit hospital at 8 weeks (visit 3) and 12 weeks (visit 4) and then examine the factor of the outcome measure following the clinical protocol |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 19 to 80 years-old
- Subject who has difficulty in respiratory symptoms and routine with the criteria as below 1) mMRC(modified Medical Research Council Dyspnea Scale) 1 point at least 2) In accordance with Pulmonary function test(PFT/LET/EEG) examined, if there is in one of the following cases as below [a lung cancer patient] (FVC or FEV1 < 80%), [No lung cancer patient] (Post-bronchodilator FEV1/FVC < 0.7) and (Post-bronchodilator FEV1 < 80%)
- Subject with an Android smartphone (OS 8.0 or higher, internal memory (HDD) of 32GB or higher) or iPhone (iOS 13.0 or higher, internal memory (HDD of 32GB or higher)
- Subject who can use effectively smartphone and mobile software
- Subject who brings their smartphone for a walking test during 12 weeks of the clinical trial.
Key exclusion criteria (10 listed)
- Subject who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc.
- Subject who participate in respiratory rehabilitation treatment within 6 months of the screening date
- Subject who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
- Subject who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
- a pulmonary arterial hypertension subject
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 |
|---|---|---|
| Conventional rehabilition treatment(e.g leaflet) educated by hospitalAlso: the conventional rehabilitation treatmentActive Comparator: subjects who are trained in accordance with the conventional manual treatment of Respiratory rehabilitation in the clinical institution and taking care home-based management. The manual contents * method of the conventional rehabilitation treatment * intensity for aerobic exercise and anaerobic exercise | Behavioural | Comparator |
| Digital treatment based on Respiratory Rehabilitation SoftwareAlso: Respiratory Rehabilitation SoftwareExperimental: subjects who use the software as a home-based Digital Respiratory Rehabilitation software It is intended for subjects who are prescribed a respiratory rehabilitation exercise to improve their physical condition. The software also helps them to do self-rehabilitation exercise. | Device | Experimental treatment |
Primary outcome
The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 12 weeks after respiratory rehabilitation compared to the baseline.
Time frame: 12 weeks
the primary efficacy variable is the change of respiratory function parameters as a 6-minute walking distance(6MWT) in meters(m) at V4 compared with the baseline(V2). The value of 6MWD at V2 adjust as the value of covariate for statistical significance between the groups.
10 secondary outcomes
The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 8 weeks after respiratory rehabilitation compared to the baseline.
Time frame: 8 weeks
The amount of change in the modified medical ressearch council Dyspnea scale (mMRC) scores at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
Time frame: 8 and 12 weeks
The amount of change in the Structures Respiratory Questionnaire (SGRQ) score at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
Time frame: 8 and 12 weeks
The amount of change in the Hospital Anxiety and Depression Scale (HADS) at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
Time frame: 8 and 12 weeks
The amount of change in the average number of daily steps per week during the respiratory rehabilitation management period (number of times)
Time frame: per week for 12weeks
The number of times in the use of medical support (days of hospitalization)
Time frame: 12 weeks
The number of times in the use of medical support (days of emergency room visits)
Time frame: 12 weeks
Abnormal case (safety evaluation variable)
Time frame: 8 and 12 weeks
Patient Global Assessment (PGA) evaluation for 12 weeks after respiratory rehabilitation management
Time frame: 12 weeks
Evaluation of the number of treatments during the respiratory rehabilitation management period (number of times)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 40854157Chung C, Kim DK, Lee JK, Heo EY, Kwon H, Kim D, Kim WJ, Lee SW. Smartphone App-Guided Pulmonary Rehabilitation in Chronic Respiratory Diseases: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Aug 25;13:e64884. doi: 10.2196/64884.
- 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.
Seiwon Lee contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional rehabilition treatment(e.g leaflet) educated by hospital and Digital treatment based on Respiratory Rehabilitation Software in people with Respiratory System Disease and Chronic Obstructive Pulmonary Disease, run by Lifesemantics Corp. at 3 sites in South Korea.
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 7 inclusion and 10 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sumin Han (+82-1661-2858, sm.han@lifesemantics.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 12 weeks after respiratory rehabilitation compared to the baseline. (time frame: 12 weeks). 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 NCT05299385, which also lists 1 linked publication.
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 29 Mar 2022.