CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Placebos +3 moredrug
Likely dose
Budesonide 180–360 mcg, Formoterol 12 mcg in combination (Symbicort) as single-dose; individual arms: Budesonide (inhaler, dose not specified), Formoterol 12 mcg, PlaceboAI-extracted
Key inclusion· 4
  • ✓Mild steroid-naïve asthma (ATS criteria)
  • ✓FEV1 >70% predicted
  • ✓Able to produce sputum after sputum induction
  • ✓Exhaled nitric oxide (at 50 mL/s flow) ≥20 ppb
Key exclusion· 9
  • ✕Current upper respiratory tract infections
  • ✕Use of inhaled or oral glucocorticosteroids within 4 weeks prior to screening
  • ✕Treatment with antileukotrienes, theophylline, tiotropium, or ipratropium within 2 weeks prior to screening
  • ✕Hypersensitivity to investigational drugs or lactose

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

Search/NCT00159263
NCT00159263N/ACompleted
CompareCT.gov

Effect of Symbicort on GR (Glucocorticoid Receptor) Translocation in Induced Sputum in Comparison With Budesonide, Formoterol and Placebo. A Single Dose Exploratory Study in Patients With Mild Asthma

Imperial College London·interventional·Posted Sep 12, 2005·Updated Sep 27, 2019

In Brief

A clinical study evaluating Placebos, Formoterol Inhalant Powder, and 2 other interventions for Asthma. Completed, enrolled 10 participants across 1 site.

Detailed Summary

To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchial and alveolar fraction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom
CollaboratorsAstraZeneca

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartNov 1, 2004
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.8 years ago

Interventions

Placebosdrug

Dry powder inhaler

Formoterol Inhalant Powderdrug

12ug

Budesonide Powderdrug

Inhaler

Budesonide and Formoterol Productdrug

Combination Inhaler, Symbicort