Idiopathic Pulmonary FibrosisNCT02176707
Modelling of Quality Life, Clinical and Physiological Measures in Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis and Dyspnoea, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
As there are no validated tools for assessing patient reported outcomes or health related quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised different methods. This means that comparison of the outcomes of studies is difficult or inaccurate. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Dyspnoea, Anxiety
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Feb 2017
- 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: Patients will be identified by hospital databases, patient registries and clinical notes and approached by the patients' attending physician or clinical team.
Who may be able to join
- Age greater than 40 years.
- IPF based on multi-disciplinary following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or usual interstitial pneumonia (UIP) histology confirmed by surgical lung biopsy consensus according to international guidelines.
- Patients may receive oral prednisolone up to a dose of 10 mg per day, anti-oxidant therapy or pirfenidone at study entry.
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 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.
- Unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
As there are no validated tools for assessing patient reported outcomes or health related quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised different methods. This means that comparison of the outcomes of studies is difficult or inaccurate. By collecting different quality of life tools and patient reported outcome at the same time, it will be possible to map or model the results of one tool or groups of tools onto another. 250 patients with IPF will be asked to complete the EuroQoL 5D, Kings Brief Interstitial Lung Disease questionnaire, St George's Respiratory Questionnaire, MRC dyspnoea scale, University of California, San Diego shortness of breath questionnaire and the Hospital Anxiety and Depression Scale, along with spirometry every 3 months, and undergo a 6 minute walk test every 6 months, over a 12 month period. Prognostic models will be constructed from all the clinical (questionnaire and function) measures a linear regression model.
Read the detailed description
There are no validated or accepted tools for assessing health related quality of life (HRQOL) or dyspnoea in patients with idiopathic pulmonary fibrosis (IPF) and there are no accepted or recommended tools for assessing patient reported outcomes in clinical trials of patients with IPF. Assessment of these outcomes is important to patients and may be considered the most crucial outcome measures of an intervention in IPF. With this in mind, the majority of the recently reported randomised clinical studies in IPF have evaluated HRQOL and dyspnoea, most commonly as secondary outcomes, but this has been achieved by different tools. For example the Capacity studies(1) utilised the St George's Respiratory Questionnaire whereas the ASCEND (Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis) (http://clinicaltrial.gov/ct2/show/NCT01366209) study is currently assessing dyspnoea using the University of California, San Diego shortness of breath questionnaire. As there is no method of directly comparing HRQOL between different clinical evaluations in IPF, there is a desperate need to produce algorithms for relating the different outcome measures in IPF.
The St George's Respiratory Questionnaire(2) is the most commonly utilised tool in trials of IPF(3-5). Although it relates to physiological impairment in IPF(6), it was developed in patients with Chronic Obstructive Pulmonary Disease (COPD) and therefore lacks content validity. An abbreviated version (SGRQ-I) containing the questions most relevant to IPF has therefore been developed and validated(7). The Kings Brief Interstitial Lung disease (K-BILD) questionnaire is a recently validated tool for patients with interstitial lung disease not specifically idiopathic pulmonary fibrosis(8) but has not been utilised in multicentre studies to measure treatment interventions in IPF. The EuroQol 5D (EQ5D) is a well-validated global health status instrument designed for use in clinical and health-economic trials(9). This has been validated in chronic respiratory disease and has been used in several studies(4, 5, 10). In terms of assessing dyspnoea, studies have utilised the University of California, San Diego (UCSD) shortness of breath questionnaire (SOBQ)(4, 11), the medicine research council (MRC) dyspnoea score(5), and the transition dyspnoea index(12).
The investigators have conducted a brief mapping exercise based on the data from patients randomised to the placebo arm of the Treating idiopathic pulmonary fibrosis with the addition of co-trimoxazole (TIPAC) study(5). The SGRQ data were mapped onto the EQ5D data using pairs of data from individuals at the same time point with the addition demographic and lung function data(unpublished). This mapping exercise produced an equation with greater predictive strength than using data from COPD patients showing that modelling algorithms are disease specific information cannot be shared between different respiratory conditions. The investigators now wish to undertake a larger study to generate more accurate models to approximate the EQ5D and also to explore the relationship between other patient reported outcome measures. It is only by undertaking this work, that the results of individual studies can be compared.
- Conditions
- Idiopathic Pulmonary Fibrosis, Dyspnoea, Anxiety, Depression
- Keywords
- Lung Function, Exercise Capacity
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Dyspnea, Anxiety Disorders, Depression
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
St George's Respiratory Questionnaire (SGRQ)
St George's Respiratory Questionnaire (SGRQ) is a tool for assessing quality of life that has previously been validated for the use with patients with interstitial lung disease. It is a responsive tool that has three domains: symptoms, activity and impact (on daily life)
Measured: 12 month period
Kings Brief Interstitial Lung Disease questionnaire (K-BILD)
Kings Brief Interstitial Lung Disease questionnaire (K-BILD) Recently developed, this is a disease specific questionnaire validated to look at the health status of patients with a variety of forms of ILD. It consists of 15 items, and can be self-administered.
Measured: 12 month period
Secondary outcomes (1)
MRC dyspnoea scale
A simple questionnaire quantifying the degree of dyspnoea suffered by patients, and shown to correlate well with direct measures of disability including walking distance, though is not quickly responsive to change
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2016 (estimated)
- Study completionFeb 2017 (estimated)
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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- InterMune
- Responsible party
- Sponsor
- Investigators
- Andrew M Wilson, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176707
- Sponsor's protocol ID
- 2014RESP03L
- Other IDs
- 14/SW/0047
- Status last verified
- Jun 2016
- First submitted
- 25 Jun 2014
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling of Quality Life, Clinical and Physiological Measures in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02176707
- Acronym / sponsor ID
- 2014RESP03L
- Conditions
- Idiopathic Pulmonary Fibrosis, Dyspnoea, Anxiety, Depression
- Keywords
- Lung Function, Exercise Capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- InterMune
- Study start
- Jun 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 27 Jun 2014 (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.
As there are no validated tools for assessing patient reported outcomes or health related quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised different methods. This means that comparison of the outcomes of studies is difficult or inaccurate. By collecting different quality of life tools and patient reported outcome at the same time, it will be possible to map or model the results of one tool or groups of tools onto another. 250 patients with IPF will be asked to complete the EuroQoL 5D, Kings Brief Interstitial Lung Disease questionnaire, St George's Respiratory Questionnaire, MRC dyspnoea scale, University of California, San Diego shortness of breath questionnaire and the Hospital Anxiety and Depression Scale, along with spirometry every 3 months, and undergo a 6 minute walk test every 6 months, over a 12 month period. Prognostic models will be constructed from all the clinical (questionnaire and function) measures a linear regression model.
Detailed description
There are no validated or accepted tools for assessing health related quality of life (HRQOL) or dyspnoea in patients with idiopathic pulmonary fibrosis (IPF) and there are no accepted or recommended tools for assessing patient reported outcomes in clinical trials of patients with IPF. Assessment of these outcomes is important to patients and may be considered the most crucial outcome measures of an intervention in IPF. With this in mind, the majority of the recently reported randomised clinical studies in IPF have evaluated HRQOL and dyspnoea, most commonly as secondary outcomes, but this has been achieved by different tools. For example the Capacity studies(1) utilised the St George's Respiratory Questionnaire whereas the ASCEND (Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis) (http://clinicaltrial.gov/ct2/show/NCT01366209) study is currently assessing dyspnoea using the University of California, San Diego shortness of breath questionnaire. As there is no method of directly comparing HRQOL between different clinical evaluations in IPF, there is a desperate need to produce algorithms for relating the different outcome measures in IPF.
The St George's Respiratory Questionnaire(2) is the most commonly utilised tool in trials of IPF(3-5). Although it relates to physiological impairment in IPF(6), it was developed in patients with Chronic Obstructive Pulmonary Disease (COPD) and therefore lacks content validity. An abbreviated version (SGRQ-I) containing the questions most relevant to IPF has therefore been developed and validated(7). The Kings Brief Interstitial Lung disease (K-BILD) questionnaire is a recently validated tool for patients with interstitial lung disease not specifically idiopathic pulmonary fibrosis(8) but has not been utilised in multicentre studies to measure treatment interventions in IPF. The EuroQol 5D (EQ5D) is a well-validated global health status instrument designed for use in clinical and health-economic trials(9). This has been validated in chronic respiratory disease and has been used in several studies(4, 5, 10). In terms of assessing dyspnoea, studies have utilised the University of California, San Diego (UCSD) shortness of breath questionnaire (SOBQ)(4, 11), the medicine research council (MRC) dyspnoea score(5), and the transition dyspnoea index(12).
The investigators have conducted a brief mapping exercise based on the data from patients randomised to the placebo arm of the Treating idiopathic pulmonary fibrosis with the addition of co-trimoxazole (TIPAC) study(5). The SGRQ data were mapped onto the EQ5D data using pairs of data from individuals at the same time point with the addition demographic and lung function data(unpublished). This mapping exercise produced an equation with greater predictive strength than using data from COPD patients showing that modelling algorithms are disease specific information cannot be shared between different respiratory conditions. The investigators now wish to undertake a larger study to generate more accurate models to approximate the EQ5D and also to explore the relationship between other patient reported outcome measures. It is only by undertaking this work, that the results of individual studies can be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic pulmonary fibrosis sufferers | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified by hospital databases, patient registries and clinical notes and approached by the patients' attending physician or clinical team.
Key inclusion criteria (3 listed)
- Age greater than 40 years.
- IPF based on multi-disciplinary following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or usual interstitial pneumonia (UIP) histology confirmed by surgical lung biopsy consensus according to international guidelines.
- Patients may receive oral prednisolone up to a dose of 10 mg per day, anti-oxidant therapy or pirfenidone at study entry.
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 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.
- 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
St George's Respiratory Questionnaire (SGRQ)
Time frame: 12 month period
St George's Respiratory Questionnaire (SGRQ) is a tool for assessing quality of life that has previously been validated for the use with patients with interstitial lung disease. It is a responsive tool that has three domains: symptoms, activity and impact (on daily life)
Kings Brief Interstitial Lung Disease questionnaire (K-BILD)
Time frame: 12 month period
Kings Brief Interstitial Lung Disease questionnaire (K-BILD) Recently developed, this is a disease specific questionnaire validated to look at the health status of patients with a variety of forms of ILD. It consists of 15 items, and can be self-administered.
1 secondary outcome
MRC dyspnoea scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
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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.
Andrew M Wilson 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 and Dyspnoea, 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 3 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: status not confirmed, as of the sponsor's last update on 13 Jun 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?
Results are not available in the source record.
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?
St George's Respiratory Questionnaire (SGRQ) (time frame: 12 month period). 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 13 Jun 2016.