Airway ResponseNCT07035743
Bronchial Response to Exercise After Double Lung Transplantation
An observational study of Airway Response and Lung Transplant Recipients, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate the airway response to exercise and its association with breathlessness in double lung transplant recipients by comparing responses during 5-minute and 15-minute exercise durations. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Airway Response, Lung Transplant Recipients, Lung Transplant
- What is being tested?
- Exercise
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: double lung transplantation recipients
Who may be able to join
- Received double lung transplantation
- ≥ 3 months post-transplant
Who cannot join
- Diagnosis of asthma
- Significant airflow limitation (≤50% FEV1 predicted)
- Inability to cooperate with the required tests and measurements
- Recent infection or rejection within 1 month
- Exercise contraindication (e.g., recent heart attack or stroke within 3 months, uncontrolled hypertension, known aortic aneurysm, unstable cardiac ischemia, malignant arrhythmias)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, 33305
Mei-Chun Wan, +886-3-3281200 ext. 2658, alliewan@cgmh.org.tw
Mei-Chun Wan, +886-3-3281200 ext. 2657, r10428001@ntu.edu.tw
About this study
This study aims to investigate the airway response to exercise and its association with breathlessness in double lung transplant recipients by comparing responses during 5-minute and 15-minute exercise durations.
Read the detailed description
Participants will undergo a constant workload challenge set at 60% of their peak oxygen uptake in 2 separate sessions: a 5-minute and a 15-minute exercise session, conducted in a random order. Ratings of perceived exertion will be measured every 5 minutes during exercise. Forced expiratory volume in 1 second will be performed before exercise, immediately post-exercise, and at 5, 10, 15, 20, and 30 minutes post-exercise in order to assess the airway response.
- Being tested
- Exercise
- Keywords
- airway response, double lung transplantation, exercise challenge test, dyspnea, breathlessness
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called 5-minute exercise
5 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing
ExerciseOther
Also called 15-minute exercise
15 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing
| Study group | Role | What they receive |
|---|---|---|
| double lung transplant recipients | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in FEV1 from baseline
Percentage change in FEV1 from baseline at immediately post-exercise, 5, 10, 15, 20, and 30 minutes post-exercise.
Measured: from enrollment to up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start5 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Airway ResponseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035743
- Sponsor's protocol ID
- 202500344B0
- Status last verified
- Jan 2026
- First submitted
- 10 Jun 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zantah M, Pandya A, Marchetti N, Jacobs MR, Criner GJ. Lung Denervation and Its Effect on Bronchial Responsiveness Following Lung Transplant Surgery2020.
Stanbrook MB, Kesten S. Bronchial hyperreactivity after lung transplantation predicts early bronchiolitis obliterans. Am J Respir Crit Care Med. 1999 Dec;160(6):2034-9. doi: 10.1164/ajrccm.160.6.9801037.
PubMed 10588625Reid DW, Walters EH, Johns DP, Ward C, Burns GP, Liakakos P, Williams TJ, Snell GI. Bronchial hyperresponsiveness and the bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2005 Apr;24(4):489-92. doi: 10.1016/j.healun.2004.02.006.
PubMed 15797754Herve P, Picard N, Le Roy Ladurie M, Silbert D, Cerrina J, Le Roy Ladurie F, Chapelier A, Dartevelle P, Simonneau G, Parquin F, et al. Lack of bronchial hyperresponsiveness to methacholine and to isocapnic dry air hyperventilation in heart/lung and double-lung transplant recipients with normal lung histology. The Paris-Sud Lung Transplant Group. Am Rev Respir Dis. 1992 Jun;145(6):1503-5. doi: 10.1164/ajrccm/145.6.1503.
PubMed 1596027Glanville AR, Theodore J, Baldwin JC, Robin ED. Bronchial responsiveness after human heart-lung transplantation. Chest. 1990 Jun;97(6):1360-6. doi: 10.1378/chest.97.6.1360.
PubMed 2140767Glanville AR, Gabb GM, Theodore J, Robin ED. Bronchial responsiveness to exercise after human cardiopulmonary transplantation. Chest. 1989 Aug;96(2):281-6. doi: 10.1378/chest.96.2.281.
PubMed 2666042
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Response to Exercise After Double Lung Transplantation
- ClinicalTrials.gov ID
- NCT07035743
- Acronym / sponsor ID
- 202500344B0
- Keywords
- airway response, double lung transplantation, exercise challenge test, dyspnea, breathlessness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
This study aims to investigate the airway response to exercise and its association with breathlessness in double lung transplant recipients by comparing responses during 5-minute and 15-minute exercise durations.
Detailed description
Participants will undergo a constant workload challenge set at 60% of their peak oxygen uptake in 2 separate sessions: a 5-minute and a 15-minute exercise session, conducted in a random order. Ratings of perceived exertion will be measured every 5 minutes during exercise. Forced expiratory volume in 1 second will be performed before exercise, immediately post-exercise, and at 5, 10, 15, 20, and 30 minutes post-exercise in order to assess the airway response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| double lung transplant recipients | – | Other: Exercise |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- double lung transplantation recipients
Key inclusion criteria (2 listed)
- Received double lung transplantation
- ≥ 3 months post-transplant
Key exclusion criteria (5 listed)
- Diagnosis of asthma
- Significant airflow limitation (≤50% FEV1 predicted)
- Inability to cooperate with the required tests and measurements
- Recent infection or rejection within 1 month
- Exercise contraindication (e.g., recent heart attack or stroke within 3 months, uncontrolled hypertension, known aortic aneurysm, unstable cardiac ischemia, malignant arrhythmias)
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 |
|---|---|---|
| ExerciseAlso: 5-minute exercise5 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing | Other | double lung transplant recipients |
| ExerciseAlso: 15-minute exercise15 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing | Other | double lung transplant recipients |
Primary outcome
Percentage change in FEV1 from baseline
Time frame: from enrollment to up to 12 weeks
Percentage change in FEV1 from baseline at immediately post-exercise, 5, 10, 15, 20, and 30 minutes post-exercise.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- BackgroundZantah M, Pandya A, Marchetti N, Jacobs MR, Criner GJ. Lung Denervation and Its Effect on Bronchial Responsiveness Following Lung Transplant Surgery2020.
- Background: PubMed 10588625Stanbrook MB, Kesten S. Bronchial hyperreactivity after lung transplantation predicts early bronchiolitis obliterans. Am J Respir Crit Care Med. 1999 Dec;160(6):2034-9. doi: 10.1164/ajrccm.160.6.9801037.
- Background: PubMed 15797754Reid DW, Walters EH, Johns DP, Ward C, Burns GP, Liakakos P, Williams TJ, Snell GI. Bronchial hyperresponsiveness and the bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2005 Apr;24(4):489-92. doi: 10.1016/j.healun.2004.02.006.
- Background: PubMed 1596027Herve P, Picard N, Le Roy Ladurie M, Silbert D, Cerrina J, Le Roy Ladurie F, Chapelier A, Dartevelle P, Simonneau G, Parquin F, et al. Lack of bronchial hyperresponsiveness to methacholine and to isocapnic dry air hyperventilation in heart/lung and double-lung transplant recipients with normal lung histology. The Paris-Sud Lung Transplant Group. Am Rev Respir Dis. 1992 Jun;145(6):1503-5. doi: 10.1164/ajrccm/145.6.1503.
- Background: PubMed 2140767Glanville AR, Theodore J, Baldwin JC, Robin ED. Bronchial responsiveness after human heart-lung transplantation. Chest. 1990 Jun;97(6):1360-6. doi: 10.1378/chest.97.6.1360.
- Background: PubMed 2666042Glanville AR, Gabb GM, Theodore J, Robin ED. Bronchial responsiveness to exercise after human cardiopulmonary transplantation. Chest. 1989 Aug;96(2):281-6. doi: 10.1378/chest.96.2.281.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Response and Lung Transplant Recipients, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei-Chun Wan (+886-3-3281200 ext. 2658, alliewan@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in FEV1 from baseline (time frame: from enrollment to up to 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 NCT07035743, which also lists 6 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 2 Nov 2026.