A phase 2a study of toreforant, a histamine H4 receptor antagonist, in eosinophilic asthma.
Ann Allergy Asthma Immunol
; 121(5): 568-574, 2018 11.
Article
em En
| MEDLINE
| ID: mdl-30102965
ABSTRACT
BACKGROUND:
Data from preclinical and clinical studies support the evaluation of histamine 4 receptor antagonists in the treatment of asthma. Toreforant is a selective histamine 4 receptor antagonist that could be effective in patients with eosinophilic asthma.OBJECTIVE:
To evaluate the efficacy and safety of toreforant in patients with eosinophilic, persistent asthma that was inadequately controlled despite current treatment.METHODS:
In this phase 2a, multicenter, randomized, double-blinded, parallel-group, placebo-controlled, proof-of-concept study, 162 eligible patients were randomized (11) to placebo or 30 mg of toreforant once daily through week 24 and followed for 4 weeks. The primary end point was change from baseline in pre-bronchodilator percent-predicted forced expiratory volume in 1 second at week 16. Secondary end points included change from baseline at week 16 in postbronchodilator percent-predicted forced expiratory volume in 1 second, Asthma Control Questionnaire scores, weekly averages of Daytime and Nighttime Asthma Diary Symptom Scores, and weekly average of number of puffs in a day that rescue medication was used.RESULTS:
There was no significant difference between groups in pre-bronchodilator percent-predicted forced expiratory volume in 1 second at week 16 (difference in least-square means -0.19%; 95% confidence interval -3.01 to 2.64; Pâ¯=â¯.90). Similarly, there were no significant differences between groups at week 16 in changes from baseline in the secondary end points (P ≥ .30). Toreforant was generally well tolerated. No deaths or serious adverse events were reported at any time point.CONCLUSION:
Toreforant, at the dose tested, failed to provide therapeutic benefit in this population of patients with uncontrolled, eosinophilic, persistent asthma. TRIAL REGISTRATION ClinicalTrials.gov, NCT01823016.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Eosinofilia Pulmonar
/
Asma
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Receptores Histamínicos H4
/
Antagonistas dos Receptores Histamínicos
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Female
/
Humans
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Male
/
Middle aged
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article