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NCT03136120
Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
trial testing Ipratropium Bromide in Lung Diseases, Interstitial in 8 participants. Completed in 13 November 2018.
13 November 2018
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 8 |
| Start date | 21 November 2017 |
| Primary completion | 13 November 2018 |
| Estimated completion | 13 November 2018 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Ipratropium Bromide — full drug profile →
- Flexible Bronchoscopy/Biopsy
Conditions studied
- Lung Diseases, Interstitial — all drugs for Lung Diseases, Interstitial →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
18 and older, any sex, with Lung Diseases, Interstitial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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, 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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mass spectrometry detection of inhaled drug in distal fibrotic lung.
Mikolasch TA, Oballa E, Vahdati-Bolouri M, Jarvis E, et al · · 2022 · cited 1× · PMID 35546672 · DOI 10.1186/s12931-022-02026-5 -
Mass Spectrometry Detection of Inhaled Drug in Distal Fibrotic Lung
Mikolasch T, Obella E, Vahdati-Bolouri M, Morrell J, et al · · 2021 · DOI 10.21203/rs.3.rs-515610/v1
Verify or expand the search:
- PubMed search for NCT03136120
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Lung Diseases, Interstitial
Currently open trials in the same condition.
- NCT05819385 — Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS) · recruiting
- NCT06325696 — H01 in Adults With Interstitial Lung Disease (The SOLIS Study) · Phase 2 · recruiting
- NCT06572384 — A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tiss · Phase 3 · recruiting
- NCT05867914 — Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD · NA · active not recruiting
- NCT06440746 — Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases · Phase 2, PHASE3 · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03136120 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 29 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03136120.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing