Clinical trial NCT05299385: The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)
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.)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Respiratory System Disease
Chronic Obstructive Pulmonary Disease
Asthma Copd
Lung Cancer
Lung Diseases
Pulmonary Rehabilitation
Respiratory Rehabilitation
Home Based Rehabilitation
Mobile Application
Rehabilitation
Keywords: DTx
Digital therapeutics
PR
COPD
Lead sponsor: Lifesemantics Corp.
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
name: KangWon National University Hospital
name: SMG-SNU Boramae Medical Center
First posted: 2022-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Cancer, etc.)


Eligibility criteria: Inclusion Criteria:

1. 19 to 80 years-old
2. 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%)
3. 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)
4. Subject who can use effectively smartphone and mobile software
5. Subject who brings their smartphone for a walking test during 12 weeks of the clinical trial.
6. Subject who makes the decision voluntarily for participating in the clinical trial and to write their signature to the consent of subject's explanation.
7. Subject who complies with the clinical protocol

Exclusion Criteria:

1. Subject who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc.
2. Subject who participate in respiratory rehabilitation treatment within 6 months of the screening date
3. Subject who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
4. Subject who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
5. a pulmonary arterial hypertension subject
6. Subject prescribed physical(e.g. lower-leg joint surgery, neurological limitation) or cognitive factors(e.g. psychical disorder)
7. Pregnant or lactating women
8. Subject who is unable to read text and tough to communicate
9. Subject who has participated in other clinical trials within 90 days of the screening date or participating in other clinical trials.
10. 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)

Primary outcomes:
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.
timeFrame: 12 weeks
Secondary outcomes:
measure: The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 8 weeks after respiratory rehabilitation compared to the baseline.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 and 12 weeks
measure: The amount of change in the Structures Respiratory Questionnaire (SGRQ) score at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
timeFrame: 8 and 12 weeks
measure: The amount of change in the Hospital Anxiety and Depression Scale (HADS) at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.
timeFrame: 8 and 12 weeks
measure: The amount of change in the average number of daily steps per week during the respiratory rehabilitation management period (number of times)
timeFrame: per week for 12weeks
measure: The number of times in the use of medical support (days of hospitalization)
timeFrame: 12 weeks
measure: The number of times in the use of medical support (days of emergency room visits)
timeFrame: 12 weeks
measure: Abnormal case (safety evaluation variable)
timeFrame: 8 and 12 weeks
measure: Patient Global Assessment (PGA) evaluation for 12 weeks after respiratory rehabilitation management
timeFrame: 12 weeks
measure: Evaluation of the number of treatments during the respiratory rehabilitation management period (number of times)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangwon National University Hospital
Study officials:
References: