Last updated: 01/30/2023 10:10:12
Cryobiopsy study to assess drug distribution in subjects with suspected Interstitial Lung Disease
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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, upto 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Evaluation of the distribution of ipratropium bromide within the cryobiopsy samples
Timeframe: Up to Week 4
Secondary outcomes:
Evaluation of the distribution of ipratropium bromide within the endobronchial sample
Timeframe: Up to Week 4
Distribution of ipratropium bromide in the proximal and distal lung
Timeframe: Up to Week 4
Interventions:
Drug: Ipratropium Bromide
Procedure/surgery: Flexible Bronchoscopy/Biopsy
Enrollment:
8
Observational study model:
Cohort
Primary completion date:
2018-13-11
Time perspective:
Prospective
Clinical publications:
Theresia Mikolasch, Eunice Oballa, Mitra Vahdati-Bolouri, Josie Morrell , Emily Jarvis, Yi Cui , Anthony Cahn, Rebecca Terry, Jagdeep Sahota, Ricky Thakrar , Peter Marshall , Joanna Porter. Copy of iprat-1MS-00052574 Mass Spectrometry detection of inhaled drug in human fibrosed lung parenchyma. Respir Res. 2022;23(1):118
DOI: https://doi.org/10.1186/s12931-022-02026-5
PMID: 35546672
Medical condition
Lung Diseases, Interstitial
Product
ipratropium bromide
Collaborators
University College London Hospitals (UCLH)
Study date(s)
November 2017 to November 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2018-13-11
Actual study completion date
2018-13-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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