CompletedPhase 3

Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

Bulgaria, Czechia, France420 participantsStarted 2011-01

Plain-language summary

The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit
✓. Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening
✓. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
✓. Non-smoker patient for at least 1 year and with a prior tobacco consumption \< 10 packs/year

Exclusion criteria

✕. Patient with active lung disease other than asthma (e.g. chronic bronchitis)
✕. Female patient who is pregnant or lactating
✕. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
✕. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit

What they're measuring

Severe asthma exacerbation rate

Timeframe: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months

Trial details

NCT IDNCT01449162

SponsorAB Science

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11

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