Idiopathic Pulmonary FibrosisNCT02630940
Exhaled Breath Condensate Biomarkers and Cough in IPF
An observational study of Idiopathic Pulmonary Fibrosis, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
Analysis of exhaled breath condensate biomarkers and cough severity in patients with idiopathic pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or Female Idiopathic pulmonary fibrosis sufferers over the age of 40, who have been diagnosed in accordance with either a multi-disciplinary review of their clinical history, thoracic high resolution computed tomography and/or surgical lung according to international guidelines
Who may be able to join
- Male or female above the age of 40
- IPF diagnosed by a multi-disciplinary team meeting following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or surgical lung according to international guidelines
Who cannot join
- A recognised significant co-existing respiratory disease, defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the principal investigator following multi-disciplinary discussion. For example, patients with bronchiectasis will only be included if the bronchiectasis is deemed to be traction bronchiectasis as a result of idiopathic pulmonary fibrosis
- Airflow obstruction defined as a forced expiratory volume at one second over forced vital capacity (FEV1/FVC) <60% predicted or a residual volume greater than 120% predicted
- Significant medical ,surgical or psychiatric disease that in the opinion of the patient's attending physician would exhibit a clinically relevant effect on the patient's health related quality of life
- The patient is unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR47TJ
About this study
Official title: Exhaled Breath Condensate Biomarkers and Cough in People With Idiopathic Pulmonary Fibrosis
Analysis of exhaled breath condensate biomarkers and cough severity in patients with idiopathic pulmonary fibrosis.
Read the detailed description
This study will aim to investigate the levels of the reactive oxygen species (ROS) 8-isoprostane in idiopathic pulmonary fibrosis patients' exhaled breath condensate (EBC). EBC samples will be collected using RTube, prior to analysis for levels of 8-isoprostane. An acceptability assessment will be performed for this non-invasive method of EBC collection through a non-validated questionnaire.
A regression analysis will then be performed for 8-isoprostane levels against the severity of the patient's cough, assessed through the use of the visual analogue scale for cough (VAS), the King's brief interstitial lung disease questionnaire (KBILD), the Medical Research Council (MRC) dyspnoea scale and the Leicester cough questionnaire. Alongside this an exploratory comparison of cough scores and 8 isoprostane concentration between patients with and without honeycombing and traction bronchiectasis.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
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 |
|---|---|---|
| Idiopathic pulmonary fibrosis sufferers | Male or female idiopathic pulmonary fibrosis (IPF) sufferers over the age of 40, with a confirmed diagnosis of IPF against international guidelines. Patients are devoid of significant other medical, surgical or psychiatric illnesses that may affect respiratory symptoms or disease progression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-isoprostane levels
Used for detection of 8-isoprostane levels in patients' exhaled breath condensate samples
Measured: 1 day (Single measurement )
Secondary outcomes (5)
Leicester Cough Questionnaire
Assessment of patient's cough severity
Measured: 1 day (Single measurement )
Kings brief interstitial lung disease questionnaire
Assessment of patient's cough severity \& exercise tolerance
Measured: 1 day (Single measurement )
MRC dyspnoea Scale
Assessment of patient's exercise tolerance
Measured: 1 day (Single measurement )
Visual analogue scale for Cough
Assessment of patient's cough severity
Measured: 1 day (Single measurement )
Non-validated acceptability questionnaire
Assessment of exhaled breath condensate collection method acceptability
Measured: 1 day (Single measurement )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Wilson, MD MRCP, Principal investigator, University of East AngliaChristopher Atkins, MBBS, Principal investigator, University of East AngliaAshnish Sinha, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630940
- Sponsor's protocol ID
- 152379 (113-08-15)
- Status last verified
- Jun 2016
- First submitted
- 11 Dec 2015
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Condensate Biomarkers and Cough in People With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02630940
- Acronym / sponsor ID
- 152379 (113-08-15)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Dec 2015 (estimated)
- 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.
Analysis of exhaled breath condensate biomarkers and cough severity in patients with idiopathic pulmonary fibrosis.
Detailed description
This study will aim to investigate the levels of the reactive oxygen species (ROS) 8-isoprostane in idiopathic pulmonary fibrosis patients' exhaled breath condensate (EBC). EBC samples will be collected using RTube, prior to analysis for levels of 8-isoprostane. An acceptability assessment will be performed for this non-invasive method of EBC collection through a non-validated questionnaire.
A regression analysis will then be performed for 8-isoprostane levels against the severity of the patient's cough, assessed through the use of the visual analogue scale for cough (VAS), the King's brief interstitial lung disease questionnaire (KBILD), the Medical Research Council (MRC) dyspnoea scale and the Leicester cough questionnaire. Alongside this an exploratory comparison of cough scores and 8 isoprostane concentration between patients with and without honeycombing and traction bronchiectasis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic pulmonary fibrosis sufferers | – | –Male or female idiopathic pulmonary fibrosis (IPF) sufferers over the age of 40, with a confirmed diagnosis of IPF against international guidelines. Patients are devoid of significant other medical, surgical or psychiatric illnesses that may affect respiratory symptoms or disease progression. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or Female Idiopathic pulmonary fibrosis sufferers over the age of 40, who have been diagnosed in accordance with either a multi-disciplinary review of their clinical history, thoracic high resolution computed tomography and/or surgical lung according to international guidelines
Key inclusion criteria (2 listed)
- Male or female above the age of 40
- IPF diagnosed by a multi-disciplinary team meeting following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or surgical lung according to international guidelines
Key exclusion criteria (4 listed)
- A recognised significant co-existing respiratory disease, defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the principal investigator following multi-disciplinary discussion. For example, patients with bronchiectasis will only be included if the bronchiectasis is deemed to be traction bronchiectasis as a result of idiopathic pulmonary fibrosis
- Airflow obstruction defined as a forced expiratory volume at one second over forced vital capacity (FEV1/FVC) <60% predicted or a residual volume greater than 120% predicted
- Significant medical ,surgical or psychiatric disease that in the opinion of the patient's attending physician would exhibit a clinically relevant effect on the patient's health related quality of life
- The patient is unable to provide written informed consent
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
8-isoprostane levels
Time frame: 1 day (Single measurement )
Used for detection of 8-isoprostane levels in patients' exhaled breath condensate samples
5 secondary outcomes
Leicester Cough Questionnaire
Time frame: 1 day (Single measurement )
Kings brief interstitial lung disease questionnaire
Time frame: 1 day (Single measurement )
MRC dyspnoea Scale
Time frame: 1 day (Single measurement )
Visual analogue scale for Cough
Time frame: 1 day (Single measurement )
Non-validated acceptability questionnaire
Time frame: 1 day (Single measurement )
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 1 Jul 2016.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
Andrew M Wilson, MD MRCP principal investigator
University of East Anglia
Christopher Atkins, MBBS principal investigator
University of East Anglia
Ashnish Sinha principal investigator
University of East Anglia
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 Idiopathic Pulmonary Fibrosis, run by University of East Anglia 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 2 inclusion and 4 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 1 Jul 2016. 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?
8-isoprostane levels (time frame: 1 day (Single measurement )). 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 1 Jul 2016.