CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Fluticasone Propionate +2 moredrug
Likely dose
Fluticasone propionate 500 µgAI-extracted
Key inclusion· 6
  • ✓COPD diagnosis with GOLD Stage 2-3 classification
  • ✓FEV1 between 30-80% predicted
  • ✓FEV1/FVC ratio less than 70%
  • ✓Cigarette smoking history of at least 10 pack-years
Key exclusion· 7
  • ✕Any history or evidence of asthma
  • ✕Hospital admission for respiratory infection within the last 6 months
  • ✕Upper respiratory infection within the last 4 weeks
  • ✕Significant or unstable cardiovascular disease including ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, or uncontrolled hypertension

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

Search/NCT00241631
NCT00241631Phase 2Completed
CompareCT.gov

Enhancement of In-vitro GC Function in Patients With COPD. A Randomised, Double Blind, Placebo Controlled, Parallel-group Study to Investigate the Effect of Theophylline and Fluticasone on Induced Sputum Cells Obtained Form COPD Patients

Imperial College London·interventional·Posted Oct 19, 2005·Updated Dec 4, 2019

In Brief

A Phase 2 clinical trial evaluating Fluticasone Propionate, placebo, and 1 other intervention for COPD. Completed, enrolled 49 participants across 1 site.

Detailed Summary

The investigator wish therefore to continue these studies on theophylline principally by conducting a small clinical pilot study on 20-30 COPD patients in a randomised, double-blind, placebo-controlled, parallel-group study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited Kingdom
CollaboratorsTanabe Pharma Corporation, Medical Research Council

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2005
Enrollment StartApr 1, 2006
Primary CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.7 years ago

Interventions

Fluticasone Propionatedrug

500 u

placebodrug

Theophyllinedrug

Theophylline placebo capcule