TNF-alpha Directed Therapy in Asthma (NCT00278083) | Clinical Trial Compass
CompletedPhase 2
TNF-alpha Directed Therapy in Asthma
United Kingdom40 participantsStarted 2001-10
Plain-language 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.
Who can participate
Age range18 Years ā 60 Years
SexALL
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Inclusion criteria
ā. Have a diagnosis of moderate asthma as defined by the American Thoracic Society criteria (NIH, 1997) for \> 1 year.
ā. Men and women, \>/= 18 to \</= 60 years of age and within 60-140% of desirable height and weight range established by the 1983 Metropolitan Life Insurance Company standards.
ā. Non-smoker for at least 1 year and less than a 10 pack year history of smoking.
ā. Screening values for haematology, biochemistry and urinalysis should be within clinically acceptable limits for this patient group.
ā. Chest radiograph at screening must show no evidence of malignancy, infection, or fibrosis. The chest radiographs should also show no apical scarring, cavitary lesions, or calcified granulomas, as evidence of past tuberculosis infections.
ā. Serological assays for hepatitis B and C must be negative for active infection.
Exclusion criteria
ā. Are pregnant, nursing, or planning a pregnancy within 12 months of enrolment.
ā. Diagnosis of chronic obstructive pulmonary disease, cystic fibrosis or other significant respiratory disorder (excluding asthma).
ā. Exacerbation of asthma symptoms requiring hospitalisation within the previous 12 weeks.
ā. History of clinically significant seasonal allergies will require that the patient is studied outside the allergy season.
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What they're measuring
1
Change from baseline (prior to visit 4: days -7 to -1) to week 8 (prior to visit 8: days 49-56) in mean morning PEFR from clinical diaries:
2
The morning PEFR for a 7 day period (week 7 to 8) will be compared to the 7 day period prior to first administration (days -7 to -1).