Airway DiseaseNCT05976919
Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease
An observational study of Airway Disease, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Respiratory disease affects one in five people and is a leading cause of global morbidity and mortality. Chronic obstructive airways diseases encompass conditions characterised by expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Disease
- What is being tested?
- Pulmonary function testing
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2023to 31 Jul 2026
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic obstructive airways disease
Who may be able to join
- Prior diagnosis of airways disease in accordance with European Respiratory Society guidelines.
- Non / ex-smokers (packs recorded as cigarettes per day / years smoked).
- Male or female aged 18-65 years
- Ability to provide written informed consent.
- Full comprehension of spoken and written English language.
- Cystic Fibrosis patients on triple CFTR modulators (90% cohort)
- Cystic Fibrosis patients on no CFTR modulators
- Healthy controls - entirely asymptomatic, no prior history of inhaler medication use and free from respiratory disease.
Who cannot join
- Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the past two months.
- Absolute or relative contraindications to cardio-pulmonary exercise testing or submaximal exercise testing.
- Absolute or relative contraindications to pulmonary function testing .
- Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e., pregnancy, recent contrast media administration or subject weight).
- Non-ambulant or musculoskeletal impairment that may affect activities of daily living or maximal exercise testing.
- Significant cognitive impairment (i.e., unable to provide written informed consent or safely / successfully perform tests).
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- Currently receiving oxygen therapy.
- Inability to consent.
- Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccus infection.
- Lung transplantation
- Diagnosis of cardiovascular disease.
- Abnormal blood screening (anaemia, moderate / severe renal failure etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Respiratory disease affects one in five people and is a leading cause of global morbidity and mortality. Chronic obstructive airways diseases encompass conditions characterised by expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality of life. The most common conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years, there has been concerted effort in the scientific and respiratory medicine community to improve the diagnosis and management of chronic obstructive airways diseases using personalised or precision medicine (i.e., tailoring therapies and interventions according to specific "treatable traits") and identifying phenotypes or endotypes using validated biomarkers. To date, however, research in this setting has primarily focussed on people with COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases. The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e., large and small airway involvement) and extra-pulmonary manifestations across the spectrum of chronic obstructive airways, and second, to determine how disease-specific treatable traits associate with physical activity and health-related quality of life.
- Conditions
- Airway Disease
- Being tested
- Pulmonary function testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testingDiagnostic test
Also called Cardiopulmonary exercise testing, Physical activity (daily step count), Dual-energy X-ray absorptiometry (body composition)
Physiological assessment of pulmonary physiology (large and small airways), exercise capacity, physical activity and body composition.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Not described Receives: Diagnostic Test: Pulmonary function testing | |
| Cystic fibrosis | Not described Receives: Diagnostic Test: Pulmonary function testing | |
| Primary ciliary dyskinesia | Not described Receives: Diagnostic Test: Pulmonary function testing | |
| Healthy adults | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Step-count
Measured: 7 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Oct 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Dr Oliver Price, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976919
- Sponsor's protocol ID
- 323694
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease
- ClinicalTrials.gov ID
- NCT05976919
- Acronym / sponsor ID
- 323694
- Conditions
- Airway Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 4 Aug 2023 (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.
Respiratory disease affects one in five people and is a leading cause of global morbidity and mortality. Chronic obstructive airways diseases encompass conditions characterised by expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality of life. The most common conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years, there has been concerted effort in the scientific and respiratory medicine community to improve the diagnosis and management of chronic obstructive airways diseases using personalised or precision medicine (i.e., tailoring therapies and interventions according to specific "treatable traits") and identifying phenotypes or endotypes using validated biomarkers. To date, however, research in this setting has primarily focussed on people with COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases. The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e., large and small airway involvement) and extra-pulmonary manifestations across the spectrum of chronic obstructive airways, and second, to determine how disease-specific treatable traits associate with physical activity and health-related quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Diagnostic Test: Pulmonary function testing |
| Cystic fibrosis | – | Diagnostic Test: Pulmonary function testing |
| Primary ciliary dyskinesia | – | Diagnostic Test: Pulmonary function testing |
| Healthy adults | – | –Healthy control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic obstructive airways disease
Key inclusion criteria (8 listed)
- Prior diagnosis of airways disease in accordance with European Respiratory Society guidelines.
- Non / ex-smokers (packs recorded as cigarettes per day / years smoked).
- Male or female aged 18-65 years
- Ability to provide written informed consent.
- Full comprehension of spoken and written English language.
Key exclusion criteria (12 listed)
- Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the past two months.
- Absolute or relative contraindications to cardio-pulmonary exercise testing or submaximal exercise testing.
- Absolute or relative contraindications to pulmonary function testing .
- Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e., pregnancy, recent contrast media administration or subject weight).
- Non-ambulant or musculoskeletal impairment that may affect activities of daily living or maximal exercise testing.
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 |
|---|---|---|
| Pulmonary function testingAlso: Cardiopulmonary exercise testing, Physical activity (daily step count), Dual-energy X-ray absorptiometry (body composition)Physiological assessment of pulmonary physiology (large and small airways), exercise capacity, physical activity and body composition. | Diagnostic test | Asthma, Cystic fibrosis, Primary ciliary dyskinesia |
Primary outcome
Physical activity
Time frame: 7 day period
Step-count
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 24 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disease, run by University of Leeds at 1 site in United Kingdom.
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 8 inclusion and 12 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 24 Aug 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 United Kingdom. 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?
Physical activity (time frame: 7 day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.