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Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT03136120
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Interstitial lung disease (ILD) often affects distal lung, and the evaluation of drug distribution to the relevant lung compartments is essential for development of new treatment options. This single center study will utilize samples obtained by transbronchial cryobiopsy (TBCB) procedure to assess the distribution of inhaled drugs in the lungs of the subjects with fibrotic lung disease using mass spectrometry techniques. The study will have a single visit and will include approximately 20 adult subjects with suspected fibrotic ILD and requiring TBCB as part of their diagnostic assessment. This will provide TBCB samples from up to 20 subjects, up to 5 of whom may also provide endobronchial forceps biopsy samples. The study will have 3 phases including screening to check the eligibility, biopsy phase in which all subjects will receive nebulized ipratropium bromide 500 microgram (mcg) for 10 minutes immediately before undergoing bronchoscopy and follow up phase from 7 to 14 days after the procedure. Drug distribution in the lung will be assessed by analyzing biopsy samples collected using mass spectrometry and imaging techniques.

Condition or disease Intervention/treatment
Lung Diseases, Interstitial Drug: Ipratropium Bromide Procedure: Flexible Bronchoscopy/Biopsy

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Assess Inhaled Drug Distribution in the Distal Lung and Interstitium Using Cryobiopsy Samples From Subjects With Suspected Interstitial Lung Disease Undergoing Cryobiopsy for Clinical Reasons
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Subjects with suspected fibrotic ILD
Eligible subjects will receive nebulized ipratropium bromide 500 mcg for 10 minutes. The subjects will be sedated for bronchoscopic procedure as per routine practice for subjects having bronchoscopy. Cryobiopsy samples for this study will be taken after samples required for diagnosis has been taken and it is safe to do so. One to three endobronchial forceps biopsy samples will be taken from up to 5 subjects to allow comparison of proximal and distal drug distribution.
Drug: Ipratropium Bromide
Single dose of 500 mcg Ipratropium nebulizer solution will be administered to all subjects via inhalation route using nebulizer for 10 minutes. Ipratropium bromide is a clear, colorless nebulizer solution available in white plastic ampoules.

Procedure: Flexible Bronchoscopy/Biopsy
After biopsy samples required for diagnosis have been collected, additional one to two TBCB samples will be taken for this study. 3-5 endobronchial biopsy samples will be taken from up to 5 subjects to compare drug distribution in proximal and distal lung.




Primary Outcome Measures :
  1. Evaluation of the distribution of ipratropium bromide within the cryobiopsy samples [ Time Frame: Up to Week 4 ]
    Images and data will be generated using mass spectrometric techniques and histology to show the distribution of ipratropium bromide within the lung cryobiopsy samples taken from subjects with suspected Interstitial Lung disease.


Secondary Outcome Measures :
  1. Evaluation of the distribution of ipratropium bromide within the endobronchial sample [ Time Frame: Up to Week 4 ]
    Images and data will be generated using mass spectrometric techniques and histology to show the distribution of ipratropium bromide within the endobronchial samples taken from subjects with suspected Interstitial Lung disease.

  2. Distribution of ipratropium bromide in the proximal and distal lung [ Time Frame: Up to Week 4 ]
    1 to 3 endobronchial biopsy samples will be taken from up to 5 subjects to allow comparison of proximal and distal drug distribution.


Biospecimen Retention:   Samples With DNA
Lung biopsy samples collected from fibrotic regions of the lung using transbrochial cryobiopsy technique will be collected for this study. Endobronchial biopsy samples will also be taken. The samples will be embedded to a suitable polymer and frozen at -80 degree Celsius ready for analysis.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female subjects above 18 years of age with suspected ILD referred for TBCB for clinical reasons, as part of their diagnostic work up, will be included in this study.
Criteria

Inclusion Criteria:

  • 18 and above years of age inclusive, at the time of signing the informed consent.
  • Subjects with suspected ILD listed for TBCB for clinical reasons following review by the ILD services at University College London Hospitals (UCLH) in whom diagnosis has remained unclear following radiological and clinical assessment.
  • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied, may be included only if the investigator in consultation with the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Male or Female.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions.

Exclusion Criteria:

  • Subjects who have a known drug allergy or other contra-indication to ipratropium bromide.
  • Known hypersensitivity to atropine or ipratropium bromide or any other known drug allergies that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
  • As a result of the medical history, physical examination or screening investigations, the physician responsible considers the subject unfit for the study.
  • The subject is unable or unwilling to perform study assessments and procedures correctly.
  • Subjects with a recognized co-existing respiratory disorder (other than ILD) that in the opinion of the investigator would confound the study outcomes.

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): NCT03136120


Locations
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United Kingdom
GSK Investigational Site
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
GlaxoSmithKline
University College London Hospitals
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03136120     History of Changes
Other Study ID Numbers: 205053
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Ipratropium bromide
Cryobiopsy
TBCB
IPF
Transbronchial cryobiopsy
Interstitial lung disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Bromides
Ipratropium
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action