QNasal Phase III programme indicates positive safety/efficacy profile in treatment of SAR/PAR
Teva Pharmaceutical Industries has revealed positive findings from Phase III studies that examined the efficacy and safety profile as well as impact on quality of life of QNasal (beclomethasone dipropionate [BDP]) nasal aerosol, a non-aqueous, 'dry' nasal aerosol corticosteroid for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
In a long-term (52-week), double-blind, placebo-controlled, parallel-group study, 529 patients with PAR, aged 12 years and older, were randomised to receive once-daily treatment with QNasal 320mcg or placebo. The primary endpoint showed a p<0.001 change from baseline weekly averages of the subject recorded 24-hour reflective nasal symptom scores (rTNSS) over the first 30 weeks of the treatment period. Additional 52 weeks of treatment data there were significantly greater improvements from baseline over a 24-hour period in both rTNSS (-1.09 [95 per cent CI: -1.6, -0.6], p<0.001) and instantaneous nasal symptom scores (iTNSS) (-1.10 [95 per cent CI: -1.6, -0.6]; p<0.001) compared with placebo.
Additionally, greater improvements in individual nasal symptoms (nasal congestion, nasal itching, rhinorrhea and sneezing) were shown in the QNasal group compared with placebo. QNasal was generally well-tolerated with a safety profile similar to placebo with the exception of epistaxis, which occurred more frequently with the active treatment. The most commonly reported adverse events (5 per cent or more subjects) were nasopharyngitis, epistaxis, upper respiratory tract infection, sinusitis and headache. Treatment difference in the average AM and PM subject-reported rTNSS over the first six-week treatment period from the same study were also recorded. The LS mean treatment difference between QNasal 320mcg/day and placebo was -0.78 (95 per cent CI: -1.2, -0.5) (p<0.001).
Results from a six-week, double-blind, placebo-controlled, parallel-group study of patients with PAR (N=474) showed that QNasal significantly improved quality of life compared with placebo (-0.58 [95 per cent CI: -0.9, -0.2]; p=0.001), as assessed by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Improvements from baseline were greater with QNasal for all seven individual domains of the RQLQ. Physician-reported nasal symptom scores were also significantly improved (-1.22 [95 per cent CI: -1.7, -0.7]; p<0.001). The primary endpoint of change from baseline of average AM and PM subject-reported rTNSS was also significant (p<0.001).
To evaluate the safety of QNasal, a double-blind placebo- and active-controlled parallel-group study was conducted to determine the effect of six weeks of therapy with QNasal on hypothalamic-pituitary adrenal axis function (HPA-axis) in adult and adolescent patients. Treatment with QNasal at a dose of 320mcg/day was not associated with HPA-axis suppression in adult and adolescent subjects with PAR, as displayed by the geometric mean ratio for QNasal 320mcg/day to placebo (0.96, 95 per cent [CI: 0.87, 1.063]). However, HPA-axis function suppression is known to have an impact on growth in adolescent subjects.
A subgroup analysis of 25 adolescents from the same study, randomised to treatment with QNasal 320mcg/day, placebo or an active control of prednisone 10mg/day showed that, after six weeks, the geometric mean serum cortisol weighted value in patients treated with QNasal was similar to those treated with placebo (0.92 [95 per cent CI: 0.72, 1.16]). However, treatment with active control oral prednisone resulted in significant suppression of serum cortisol levels. Tthe placebo to prednisone mean serum cortisol weighted value (2.56 [95 per cent CI: 1.76, 3.71]).