Journal of Allergy and Clinical Immunology
Safety and Tolerability of Fel d 1-Derived Peptide Antigen Desensitization in Subjects with Controlled Asthma
Section snippets
Rationale
The coexistence of asthma with allergic rhinoconjunctivitis in a proportion of patients with cat allergy makes it important to establish the safety of Fel d 1-derived peptide antigen desensitization (Cat-PAD; also known as ToleroMune®Cat) in this population.
Methods
This randomised, double-blind, placebo-controlled, parallel-group, repeat-dose study evaluated the safety and tolerability of Cat-PAD in cat allergic subjects with controlled asthma. Subjects were assigned to 3 cohorts according to the medication used to control their asthma: Cohort 1, inhaled salbutamol; Cohort 2, inhaled corticosteroid; and Cohort, 3 inhaled corticosteroid plus a long-acting β2 agonist (LABA). In each cohort subjects were randomly allocated to receive 8 intradermal
Results
There were no clinically relevant changes in mean FEV1 post-dose for Cat-PAD or placebo in all three cohorts. No subjects had a reduction in FEV1>30% from baseline post-dose. VAS scores of breathlessness remained low throughout each post-dose period. The majority of adverse events were mild. One serious adverse event occurred (headache – 3 nmol Cat-PAD/inhaled corticosteroid plus LABA, judged not to be related to treatment). The incidence of asthma and associated TEAEs (cough, chest discomfort,
Conclusions
Cat-PAD (3 nmol) was safe and well tolerated in cat allergic subjects with controlled asthma treated with inhaled salbutamol, an inhaled corticosteroid or an inhaled corticosteroid plus LABA.