Interstitial Lung Disease (ILD)NCT07924462
Chronic Respiratory Disease Participant Engagement Study
An observational study of Interstitial Lung Disease (ILD) and Chronic Respiratory Diseases, run by Richmond Research Institute at 1 site in United Kingdom.
Trial summary
This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as Alpha-1 Antitrypsin Deficiency (AATD), chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, or interstitial lung disease (ILD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD), Chronic Respiratory Diseases, Alpha-1 Antitrypsin Deficiency (AATD)
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2026to 1 Aug 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants aged 18 years or older with a confirmed or suspected chronic respiratory disease, including alpha-1 antitrypsin deficiency, chronic obstructive pulmonary disease, asthma, bronchiectasis, interstitial lung disease or other chronic respiratory conditions considered appropriate by the Investigator and Sponsor, who are considering participation in future relevant clinical trials.
Who may be able to join
- Male or female participants aged ≥ 18 years at the date of signing the PIS/ICF.
- Ability to provide written, personally signed, and dated informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines E6 (R3) (2025) and applicable regulations, before any study-specific procedures are performed.
- Diagnosis with or suspicion of chronic respiratory disease including but not limited to: AATD, COPD, Asthma, Bronchiectasis, ILD and any other chronic respiratory diseases considered appropriate by the Investigator and Sponsor
Who cannot join
- Unwilling or unable to comply with the protocol-defined study assessments.
- Any other significant disease or disorder that, in the opinion of the Principal Investigator (PI) or Sponsor, may either place the participant at risk from participation, or influence the clinical baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Richmond Pharmacology Limited
London
Volunteer recruitment, +44 (0) 20 7042 5802, volunteer@richmondpharmacology.com
Edward Jackson, MBChB PhD
About this study
Official title: Engagement Study to Establish a Clinical Baseline for Adult Participants With Chronic Respiratory Diseases and Familiarise Them With the Clinical Trials Unit Environment for Future Clinical Trial Participation
This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as Alpha-1 Antitrypsin Deficiency (AATD), chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, or interstitial lung disease (ILD).
The aim of the study is to help participants become familiar with the clinical trials unit environment and research team before deciding whether they would like to take part in future clinical trials.
Read more
Participants will attend a study visit at the clinical trials unit, where they will receive a guided tour of the facilities and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available.
The information collected will help establish a clinical baseline and improve understanding of how respiratory diseases affect people in everyday life. The study will also explore how symptoms and quality of life relate to clinical measurements and other health information.
Participants will be contacted after their visit to discuss any clinically relevant findings and to answer any questions they may have. If a previously unrecognised condition is identified, participants will be advised appropriately and, with their consent, their GP may be informed to support any further care that may be needed.
The findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.
Read the detailed description
This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as AATD, COPD, asthma, bronchiectasis, or ILD.
This study will help participants become familiar with the clinical trials unit environment and research team. The findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.
This is a participant engagement study and will take about 5 weeks to complete. There is no overnight stay, and no investigational drug will be given.
The study involves two visits; Visit 1: An in-person engagement visit (Day 1) and Visit 2: A follow-up about 3 weeks (±14 days) after Day 1.
During the Day 1 visit, participants will be asked to provide written informed consent. After providing consent, participants will be given a tour of the clinical study unit to get familiar with the environment and facilities. Following informed consent on Day 1, participants will undergo a unit tour and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available.
A Follow-Up with the Study Doctor will be conducted within 3 weeks (±14 days) after Day 1 to discuss the results of the clinical assessments. The participants will have the opportunity to ask any further questions. If a participant has a confirmed new genetic or respiratory diagnosis and they are not already receiving appropriate care from a specialist, they will be provided with appropriate counselling regarding the finding and, where clinically indicated, their General Practitioner (GP) will be informed to support ongoing clinical management and will be referred to an appropriate specialist.
- Conditions
- Interstitial Lung Disease (ILD), Chronic Respiratory Diseases, Alpha-1 Antitrypsin Deficiency (AATD), Chronic Obstructive Pulmonary Disease (COPD), Asthma, Bronchiectasis
- Keywords
- Alpha-1 Antitrypsin Deficiency, AATD, chronic obstructive pulmonary disease, COPD, asthma, bronchiectasis, interstitial lung disease, ILD
- Medical subject headings
- Lung Diseases, Interstitial, alpha 1-Antitrypsin Deficiency, Pulmonary Disease, Chronic Obstructive, Asthma, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients indicating willingness to be re-contacted for future clinical trials
Measured: Until the end of the study (up to 5 weeks)]
Participation feedback questionnaire results using Participant Feedback and Clinical Research Experience Questionnaire
Measured: Until the end of the study (up to 5 weeks)]
Secondary outcomes (17)
Clinical baseline characterisation of medical history
Measured: Day 1
Clinical baseline characterisation of exacerbation history
Measured: Day 1
Clinical baseline characterisation of smoking status
Measured: Day 1
Clinical baseline characterisation of concomitant medications (con-meds)
Measured: Day 1
Clinical baseline characterisation of respiratory rate
Measured: Day 1
Clinical baseline characterisation of body temperature
Measured: Day 1
Clinical baseline characterisation of pulse rate
Measured: Day 1
Clinical baseline characterisation of oxygen saturation
Measured: Day 1
Clinical baseline characterisation of blood pressure
Measured: Day 1
Clinical baseline characterisation of Lung function for FEV1 parameter
Measured: Day 1
Clinical baseline characterisation of Lung function for FVC parameter
Measured: Day 1
Clinical baseline characterisation of Lung function for FEV1/FVC ratio
Measured: Day 1
Clinical baseline characterisation of oxygen use
Measured: Day 1
Clinical baseline characterisation of bloods including genetic testing where clinically indicated and imaging data where available.
Measured: Day 1
Number and proportion of new diagnoses following assessment
Measured: Until the end of the study (up to 5 weeks)]
Factors associated with underdiagnosis by exploring differences between patient-reported outcomes and clinical data, including potential variations by age, sex and ethnicity
Measured: Until the end of the study (up to 5 weeks)]
Differences in patient-reported outcome scores between chronic respiratory disease subgroups using EQ-5D-5L together with the EQ Visual Analogue Scale (EQ VAS)
Measured: Until the end of the study (up to 5 weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richmond Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924462
- Sponsor's protocol ID
- C26025
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of personal data with other organisations is not planned.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement Study to Establish a Clinical Baseline for Adult Participants With Chronic Respiratory Diseases and Familiarise Them With the Clinical Trials Unit Environment for Future Clinical Trial Participation
- ClinicalTrials.gov ID
- NCT07924462
- Acronym / sponsor ID
- C26025
- Conditions
- Interstitial Lung Disease (ILD), Chronic Respiratory Diseases, Alpha-1 Antitrypsin Deficiency (AATD), Chronic Obstructive Pulmonary Disease (COPD), Asthma, Bronchiectasis
- Keywords
- Alpha-1 Antitrypsin Deficiency, AATD, chronic obstructive pulmonary disease, COPD, asthma, bronchiectasis, interstitial lung disease, ILD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Richmond Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 9 Nov 2026 (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 is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as Alpha-1 Antitrypsin Deficiency (AATD), chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, or interstitial lung disease (ILD).
The aim of the study is to help participants become familiar with the clinical trials unit environment and research team before deciding whether they would like to take part in future clinical trials.
Participants will attend a study visit at the clinical trials unit, where they will receive a guided tour of the facilities and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available.
The information collected will help establish a clinical baseline and improve understanding of how respiratory diseases affect people in everyday life. The study will also explore how symptoms and quality of life relate to clinical measurements and other health information.
Participants will be contacted after their visit to discuss any clinically relevant findings and to answer any questions they may have. If a previously unrecognised condition is identified, participants will be advised appropriately and, with their consent, their GP may be informed to support any further care that may be needed.
The findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.
Detailed description
This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as AATD, COPD, asthma, bronchiectasis, or ILD.
This study will help participants become familiar with the clinical trials unit environment and research team. The findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.
This is a participant engagement study and will take about 5 weeks to complete. There is no overnight stay, and no investigational drug will be given.
The study involves two visits; Visit 1: An in-person engagement visit (Day 1) and Visit 2: A follow-up about 3 weeks (±14 days) after Day 1.
During the Day 1 visit, participants will be asked to provide written informed consent. After providing consent, participants will be given a tour of the clinical study unit to get familiar with the environment and facilities. Following informed consent on Day 1, participants will undergo a unit tour and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available.
A Follow-Up with the Study Doctor will be conducted within 3 weeks (±14 days) after Day 1 to discuss the results of the clinical assessments. The participants will have the opportunity to ask any further questions. If a participant has a confirmed new genetic or respiratory diagnosis and they are not already receiving appropriate care from a specialist, they will be provided with appropriate counselling regarding the finding and, where clinically indicated, their General Practitioner (GP) will be informed to support ongoing clinical management and will be referred to an appropriate specialist.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants aged 18 years or older with a confirmed or suspected chronic respiratory disease, including alpha-1 antitrypsin deficiency, chronic obstructive pulmonary disease, asthma, bronchiectasis, interstitial lung disease or other chronic respiratory conditions considered appropriate by the Investigator and Sponsor, who are considering participation in future relevant clinical trials.
Key inclusion criteria (3 listed)
- Male or female participants aged ≥ 18 years at the date of signing the PIS/ICF.
- Ability to provide written, personally signed, and dated informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines E6 (R3) (2025) and applicable regulations, before any study-specific procedures are performed.
- Diagnosis with or suspicion of chronic respiratory disease including but not limited to: AATD, COPD, Asthma, Bronchiectasis, ILD and any other chronic respiratory diseases considered appropriate by the Investigator and Sponsor
Key exclusion criteria (2 listed)
- Unwilling or unable to comply with the protocol-defined study assessments.
- Any other significant disease or disorder that, in the opinion of the Principal Investigator (PI) or Sponsor, may either place the participant at risk from participation, or influence the clinical baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients indicating willingness to be re-contacted for future clinical trials
Time frame: Until the end of the study (up to 5 weeks)]
Participation feedback questionnaire results using Participant Feedback and Clinical Research Experience Questionnaire
Time frame: Until the end of the study (up to 5 weeks)]
17 secondary outcomes
Clinical baseline characterisation of medical history
Time frame: Day 1
Clinical baseline characterisation of exacerbation history
Time frame: Day 1
Clinical baseline characterisation of smoking status
Time frame: Day 1
Clinical baseline characterisation of concomitant medications (con-meds)
Time frame: Day 1
Clinical baseline characterisation of respiratory rate
Time frame: Day 1
Clinical baseline characterisation of body temperature
Time frame: Day 1
Clinical baseline characterisation of pulse rate
Time frame: Day 1
Clinical baseline characterisation of oxygen saturation
Time frame: Day 1
Clinical baseline characterisation of blood pressure
Time frame: Day 1
Clinical baseline characterisation of Lung function for FEV1 parameter
Time frame: Day 1
Clinical baseline characterisation of Lung function for FVC parameter
Time frame: Day 1
Clinical baseline characterisation of Lung function for FEV1/FVC ratio
Time frame: Day 1
Clinical baseline characterisation of oxygen use
Time frame: Day 1
Clinical baseline characterisation of bloods including genetic testing where clinically indicated and imaging data where available.
Time frame: Day 1
Number and proportion of new diagnoses following assessment
Time frame: Until the end of the study (up to 5 weeks)]
Factors associated with underdiagnosis by exploring differences between patient-reported outcomes and clinical data, including potential variations by age, sex and ethnicity
Time frame: Until the end of the study (up to 5 weeks)]
Differences in patient-reported outcome scores between chronic respiratory disease subgroups using EQ-5D-5L together with the EQ Visual Analogue Scale (EQ VAS)
Time frame: Until the end of the study (up to 5 weeks)]
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 9 Nov 2026.
- Individual participant dataSharing planned: No. Sharing of personal data with other organisations is not planned.
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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 Interstitial Lung Disease (ILD) and Chronic Respiratory Diseases, run by Richmond Research Institute 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 3 inclusion and 2 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 9 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 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?
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 James Rickard, MPharm (+44 (0) 20 7042 5800, jrickard@richmondresearchinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients indicating willingness to be re-contacted for future clinical trials (time frame: Until the end of the study (up to 5 weeks)]). The study lists 2 primary outcomes in all. 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 9 Nov 2026.