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FIBRotic Interstitial Lung Disease and Nocturnal OXygen (FIBRINOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586946
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
Home sleep studies - which allow the measurement of breathing while the person sleeps - will be performed on patients with fibrotic interstitial lung disease attending two of the UK's largest respiratory medicine services.The study will investigate at how symptoms, and breathing and exercise tests differ between these two groups after 12 months of study.

Condition or disease
Idiopathic Pulmonary Fibrosis Obstructive Sleep Apnea Sleep Disturbance Sleep Hypoventilation

Detailed Description:

The interstitial lung diseases are a group of diseases in which patients develop uncontrolled scarring (called fibrosis) within the lung. This causes failure of the lung and patients become progressively more breathless over time. The commonest of these diseases is idiopathic pulmonary fibrosis and this is a devastating condition with a survival of 3-5 years.

Many people with fibrotic interstitial lung diseases have disrupted sleep as well as low oxygen levels at night or obstructive sleep apnoea (OSA - pauses in breathing at night time due to obstruction of the upper airway).

Patients with low oxygen levels at night have a worse quality of life, with fatigue during the day and survive for less long.

102 patients from specialist clinics at Guy's and St Thomas' and the Royal Brompton and Harefield NHS Foundation Trusts will be recruited. This research is funded by a grant from the British Lung Foundation. The investigators aim to compare patients with and without low oxygen levels at night by observing how their disease and quality of life changes over a year.

Patients will be asked to complete a two-night home sleep study which will involve wearing a probe over the finger connected to a sensor on the wrist. Patients will also be provided with a home spirometer to measure their breathing at home daily during the study.

Lung function testing (which is part of normal clinical practice), a six-minute walk test and quality of life questionnaires will be performed at the beginning of the study. These investigations will be repeated at six and twelve months and this will tell us how night time oxygen levels affect the progression of the disease, quality of life, exercise tolerance, hospitalisation frequency and survival of these patients.

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Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Effects of Nocturnal Hypoxaemia on Patients With Fibrotic Interstitial Lung Disease
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021





Primary Outcome Measures :
  1. Quality of life measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) [ Time Frame: 0 months,12 months ]
    Change in K-BILD score from baseline at 12 months in patients with nocturnal hypoxaemia vs those without (defined as time spent with SpO2<90% of > 10% total sleep time)


Secondary Outcome Measures :
  1. Forced vital capacity (FVC) [ Time Frame: 12 months ]
    Annualised decline in FVC in patients with nocturnal hypoxaemia vs those without

  2. Diffusion capacity of the lung for carbon monoxide (DLCO) [ Time Frame: 12 months ]
    Change in DLCO from baseline at 6 and 12 months in patients with nocturnal hypoxaemia vs those without

  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 0 months, 6 months, 12 months ]
    PSQI score at baseline, and change at 6 and 12 months in patients with nocturnal hypoxaemia vs those without

  4. Insomnia Severity Index (ISI) [ Time Frame: 0 months, 6 months, 12 months ]
    ISI score at baseline, and change at 6 and 12 months in patients with nocturnal hypoxaemia vs those without

  5. Six-minute walk test (6MWT) [ Time Frame: 0 months 6 months, 12 months ]
    Total distance (in metres) and minimum oxygen saturation during 6MWT at baseline, 6 and 12 months

  6. Exacerbation frequency and hospitalisation [ Time Frame: 12 months ]
  7. Mortality [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
DNA will be extracted and used to genotype common variants known to be associated with pulmonary fibrosis, including but not limited to Muc5b, TOLLIP and TERT. Serum and plasma will be analysed for solu-ble biomarkers including but not limited to KL-6, SP-A, SP-D, Fas, MMP1, MMP7, clusterin, dynamin, VEGF, CCL18, osteopontin, thrombospondin and inflammatory cytokines. Levels in biomarkers and geno-type frequency will be compared between subgroups of patients


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with fibrotic interstitial lung disease
Criteria

Inclusion Criteria:

  • MDT diagnosis of fibrotic interstitial lung disease including but not limited to idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), fibrotic organising pneumonia and unclassifiable fibrotic lung disease.
  • Competent to provide written consent in English

Exclusion Criteria:

  • Presence of an underlying connective tissue disease
  • Daytime/resting hypoxaemia with pO2 <8.0
  • Other indication for oxygen therapy
  • 3% ODI >15 events/hour studied or established on CPAP
  • Predominant emphysema on CT
  • Inability to provide informed consent or complete health-related quality of life questionnaires in English
  • Current participation in a research project which might alter lung function or sleep study results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586946


Contacts
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Contact: Katherine J Myall, MBChB 02071887188 ext 85834 katherine.myall@gstt.nhs.uk
Contact: Diana Roque 02071887188 ext 85808 diana.roque@gstt.nhs.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE19RT
Contact: Katheirne J Myall, MBChB    02071887188 ext 85834    katherine.myall@gstt.nhs.uk   
Royal Brompton Hospital Recruiting
London, United Kingdom, sw36np
Contact: Philip Molyneaux, PhD         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Alex West Guy's and St Thomas' NHS Foundation Trust
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04586946    
Other Study ID Numbers: Fibrinox 1.0
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be collected on paper worksheets filed in the site file and web-based electronic clinical record forms provided by Castor EDC, a secure web database which is compliant with GCP regulations, Annex 11 and 21 CFR part 11. It also complies with EU GDPR. All communication to servers is encrypted using TLS (1.1 or 1.2) through HSTS.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Hypoventilation
Dyssomnias
Parasomnias
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Idiopathic Interstitial Pneumonias
Mental Disorders
Respiratory Insufficiency
Signs and Symptoms, Respiratory