Lung Diseases, InterstitialNCT03136120
Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
An observational study of Lung Diseases, Interstitial, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Ipratropium Bromide and Flexible Bronchoscopy/Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Nov 2017to 13 Nov 2018
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Ipratropium Bromide, Flexible Bronchoscopy/Biopsy
- Keywords
- Ipratropium bromide, Cryobiopsy, TBCB, IPF, Transbronchial cryobiopsy, Interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium BromideDrug
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.
Flexible Bronchoscopy/BiopsyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ipratropium Bromide; Procedure: Flexible Bronchoscopy/Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the distribution of ipratropium bromide within the cryobiopsy samples
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.
Measured: Up to Week 4
Secondary outcomes (2)
Evaluation of the distribution of ipratropium bromide within the endobronchial sample
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.
Measured: Up to Week 4
Distribution of ipratropium bromide in the proximal and distal lung
1 to 3 endobronchial biopsy samples will be taken from up to 5 subjects to allow comparison of proximal and distal drug distribution.
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start21 Nov 2017
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136120
- Sponsor's protocol ID
- 205053
- Status last verified
- Jan 2019
- First submitted
- 27 Apr 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mikolasch TA, Oballa E, Vahdati-Bolouri M, Jarvis E, Cui Y, Cahn A, Terry RL, Sahota J, Thakrar R, Marshall P, Porter JC. Mass spectrometry detection of inhaled drug in distal fibrotic lung. Respir Res. 2022 May 11;23(1):118. doi: 10.1186/s12931-022-02026-5.
PubMed 35546672
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03136120
- Acronym / sponsor ID
- 205053
- Conditions
- Lung Diseases, Interstitial
- Keywords
- Ipratropium bromide, Cryobiopsy, TBCB, IPF, Transbronchial cryobiopsy, Interstitial lung disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with suspected fibrotic ILD | – | Drug: Ipratropium Bromide, Procedure: Flexible Bronchoscopy/BiopsyEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipratropium BromideSingle 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. | Drug | Subjects with suspected fibrotic ILD |
| Flexible Bronchoscopy/BiopsyAfter 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. | Procedure or surgery | Subjects with suspected fibrotic ILD |
Primary outcome
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.
2 secondary outcomes
Evaluation of the distribution of ipratropium bromide within the endobronchial sample
Time frame: Up to Week 4
Distribution of ipratropium bromide in the proximal and distal lung
Time frame: Up to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 35546672Mikolasch TA, Oballa E, Vahdati-Bolouri M, Jarvis E, Cui Y, Cahn A, Terry RL, Sahota J, Thakrar R, Marshall P, Porter JC. Mass spectrometry detection of inhaled drug in distal fibrotic lung. Respir Res. 2022 May 11;23(1):118. doi: 10.1186/s12931-022-02026-5.
- Individual participant dataSharing planned: No
Related trials for Lung Diseases, Interstitial
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
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.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
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 Lung Diseases, Interstitial, run by GlaxoSmithKline 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the distribution of ipratropium bromide within the cryobiopsy samples (time frame: Up to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136120, which also lists 1 linked publication.
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 29 Jan 2019.