Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 27, 2017
First Posted Date May 2, 2017
Last Update Posted Date January 29, 2019
Actual Study Start Date November 21, 2017
Actual Primary Completion Date November 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03136120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 27, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Lung Diseases, Interstitial
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • Drug: Ipratropium Bromide
  • Procedure: Flexible Bronchoscopy/Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 25, 2019)
8
Original Estimated Enrollment
 (submitted: April 27, 2017)
20
Actual Study Completion Date November 13, 2018
Actual Primary Completion Date November 13, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03136120
Other Study ID Numbers 205053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators University College London Hospitals
Investigators
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)
PRS Account GlaxoSmithKline
Verification Date January 2019