Idiopathic Pulmonary FibrosisNCT01154998
Case-Control Study of Fibrotic Interstitial Lung Disease (ILD) and Cardiac Disease / Interventions.
An observational study of Idiopathic Pulmonary Fibrosis and Interstitial Pneumonia, run by St George's Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
There is a rare condition causing scarring of the lungs termed interstitial lung disease. This comprises a group of conditions which can be divided into separate diseases. The aim of this study is compare a group of patients (the cases) with 2 types of this disease (fibrotic non-specific interstitial pneumonia (NSIP)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Interstitial Pneumonia
- How many people
- 360 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases - patients with IPF or UIP. Controls - hospital clinic attenders.
Who may be able to join
- idiopathic fibrotic lung disease
Who cannot join
- non idiopathic fibrotic lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case-Control Study of Fibrotic Interstitial Lung Disease and it's Association With Cardiac Disease or Cardiac Intervention.
There is a rare condition causing scarring of the lungs termed interstitial lung disease. This comprises a group of conditions which can be divided into separate diseases. The aim of this study is compare a group of patients (the cases) with 2 types of this disease (fibrotic non-specific interstitial pneumonia (NSIP) and idiopathic pulmonary fibrosis (IPF)) with patients without the disease. The study will look at the 2 groups and their exposures to factors such as medications, smoking, previous jobs, previous medical problems and specifically heart disease and any operations or procedures involving the heart. There have been previous studies showing a link between heart disease and scarring of the lungs. This study will look at whether this association is stronger in one or the other type of lung scarring diseases.
- Keywords
- non-specific interstitial pneumonia
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
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 |
|---|---|---|
| Cases | Not described | |
| Controls | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2011 (estimated)
- Study completionApr 2011 (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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's Healthcare NHS Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154998
- Sponsor's protocol ID
- 10/H1102/46
- Status last verified
- Jun 2010
- First submitted
- 30 Jun 2010
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Control Study of Fibrotic Interstitial Lung Disease and it's Association With Cardiac Disease or Cardiac Intervention.
- ClinicalTrials.gov ID
- NCT01154998
- Acronym / sponsor ID
- 10/H1102/46
- Keywords
- non-specific interstitial pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- St George's Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 1 Jul 2010 (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.
There is a rare condition causing scarring of the lungs termed interstitial lung disease. This comprises a group of conditions which can be divided into separate diseases. The aim of this study is compare a group of patients (the cases) with 2 types of this disease (fibrotic non-specific interstitial pneumonia (NSIP) and idiopathic pulmonary fibrosis (IPF)) with patients without the disease. The study will look at the 2 groups and their exposures to factors such as medications, smoking, previous jobs, previous medical problems and specifically heart disease and any operations or procedures involving the heart. There have been previous studies showing a link between heart disease and scarring of the lungs. This study will look at whether this association is stronger in one or the other type of lung scarring diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases - patients with IPF or UIP. Controls - hospital clinic attenders.
Key inclusion criteria (1 listed)
- idiopathic fibrotic lung disease
Key exclusion criteria (1 listed)
- non idiopathic fibrotic lung disease
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
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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.
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 Interstitial Pneumonia, run by St George's Healthcare NHS Trust 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 1 inclusion and 1 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 1 Jul 2010. 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?
Contact Felix Chua, MBBS (0208 725 1261, felix.chua@stgeorges.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 2010.