MedTrace Logo

TNF-alpha Directed Therapy in Asthma

NCT00278083 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-14

No results posted yet for this study

Summary

This trial is a randomised, single-center, placebo-controlled, double blind, parallel group study in patients with asthma symptomatic on inhaled steroids.

This trial will examine the efficacy and safety of 5 mg/kg doses of infliximab in patients with inhaled corticosteroid-dependent asthma. The primary objective of this study is to obtain pharmacological evidence for a role of the pro-inflammatory cytokine TNF-alpha in patients with asthma symptomatic on inhaled steroids and to evaluate the safety and tolerability of repeated intravenous administration of infliximab.

Conditions

Interventions

DRUG

Study drug administration

PROCEDURE

Tuberculin intradermal skin test

PROCEDURE

Lung function test for FEV1

PROCEDURE

Asthma symptom scores diary

PROCEDURE

Quality of life diary

PROCEDURE

Breath nitric oxide

PROCEDURE

Breath condensate

PROCEDURE

Sputum induction

PROCEDURE

Blood sampling

PROCEDURE

Urinalysis

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Trevor T Hansel, FRCPath PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Completion
2004-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278083 on ClinicalTrials.gov