CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
pGM169/GL67Adrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00789867
NCT00789867Phase 2Completed
CompareCT.gov

Evaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic Fibrosis

Imperial College London·interventional·Posted Nov 13, 2008·Updated Jan 18, 2020

In Brief

A Phase 2 clinical trial evaluating pGM169/GL67A for Cystic Fibrosis. Completed, enrolled 35 participants across 1 site.

Detailed Summary

The study objectives are to assess safety, tolerability and gene expression after a single dose of non-viral CFTR gene therapy (pGM169/GL67A) administered to the nose and lungs of patients with cystic fibrosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited Kingdom
CollaboratorsRoyal Brompton & Harefield NHS Foundation Trust, University of Oxford, University of Edinburgh, Cystic Fibrosis Trust, University of Pennsylvania

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2008
Enrollment StartNov 1, 2008
Primary CompletionAug 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.6 years ago

Interventions

pGM169/GL67Adrug

Received a nebulized dose via an breath-actuated nebulizer