Abstract | BACKGROUND: OBJECTIVES: The primary endpoint was the percent change from baseline in oral corticosteroids after 16 weeks of treatment. Change in asthma control ( asthma control questionnaire), exacerbation rate, pulmonary function tests, rescue medication requirement and safety were secondary endpoints. METHODS: A 16-week randomized, dose-ranging (3, 4.5, and 6 mg/kg/day), placebo-controlled study was undertaken in 44 patients with severe corticosteroid-dependent asthma who remained poorly controlled despite optimal asthma management. RESULTS: At 16 weeks of treatment, a comparable reduction in oral corticosteroids was achieved with masitinib and placebo (median reduction of -78% and -57% in the masitinib and placebo arms, respectively). Despite this similar reduction, the Asthma Control Questionnaire score was significantly better in the masitinib arm as compared to placebo with a reduction by 0.99 unit at week 16 (P < 0.001) vs 0.43 unit in the placebo arm. Masitinib therapy was associated with more transient skin rash and edema. CONCLUSIONS:
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Authors | M Humbert, F de Blay, G Garcia, A Prud'homme, C Leroyer, A Magnan, J-M Tunon-de-Lara, C Pison, M Aubier, D Charpin, I Vachier, A Purohit, P Gineste, T Bader, A Moussy, O Hermine, P Chanez |
Journal | Allergy
(Allergy)
Vol. 64
Issue 8
Pg. 1194-201
(Aug 2009)
ISSN: 1398-9995 [Electronic] Denmark |
PMID | 19614621
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Asthmatic Agents
- Benzamides
- Hydroxycorticosteroids
- Piperidines
- Protein Kinase Inhibitors
- Pyridines
- Thiazoles
- PDGF receptor tyrosine kinase
- Proto-Oncogene Proteins c-kit
- Receptors, Platelet-Derived Growth Factor
- masitinib
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Aged
- Anti-Asthmatic Agents
(administration & dosage, adverse effects)
- Asthma
(drug therapy)
- Benzamides
- Edema
(etiology)
- Exanthema
(etiology)
- Female
- France
- Humans
- Hydroxycorticosteroids
(administration & dosage)
- Male
- Medication Adherence
- Middle Aged
- Piperidines
- Protein Kinase Inhibitors
(administration & dosage, adverse effects)
- Proto-Oncogene Proteins c-kit
(metabolism)
- Pyridines
- Receptors, Platelet-Derived Growth Factor
(antagonists & inhibitors)
- Thiazoles
(administration & dosage, adverse effects)
- Treatment Outcome
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