Regulatory Decision Summary for Aermony RespiClick

The efficacy and safety of Aermony Respiclick (fluticasone propionate) were evaluated in two replicate Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials in patients with persistent asthma (Studies FSS-AS-301, FSS-AS-30017). Patients were administered Aermony Respiclick 55 mcg, 113, mcg or 232 mcg twice daily for the treatment period. The primary endpoint was change from baseline in trough forced expiratory volume in one second (FEV₁) at week 12. Secondary efficacy variables included change from baseline in the weekly average of the daily trough morning peak expiratory flow (PEF) over the 12-week treatment period, change from baseline in the weekly average of the total daily asthma symptom score and change from baseline in the Standardized Asthma Qualify of Life Questionnaire (AQLQ(S)) score at week 12. The results for Aermony Respiclick 55 mcg, 113, mcg and 232 mcg showed it provided statistically significant and clinically meaningful improvements over placebo. The results were supported by the secondary endpoints.

Supportive evidence of efficacy for the 55 mcg and 113 mcg dosage strengths was provided by a Phase 2, 12-week, dose-ranging, double-blind, placebo-controlled, and active-comparator clinical trial (FpS-AS-201) in patients 12 years and older with persistent asthma despite treatment with short-acting b2-adrenergic agonists. Both doses showed statistically significant improvement, but did not reach the minimal clinical improvement, in the primary endpoint of change from baseline in trough FEV1 over 12 weeks compared to placebo. It is important to note that the objective of the study was to evaluate a dose response and was not powered to show clinical important differences.

A second Phase 2, 12-week, dose-ranging, double-blind, placebo-controlled, and active-comparator clinical trial (FpS-AS-202) in patients 12 years and older with uncontrolled asthma despite treatment with high dose inhaled corticosteroid (ICS) therapy evaluated the efficacy and safety of Aermony Respiclick 55, 113, 232 and 434 mcg. This study did not show a clinical or statistical significant difference from placebo for the primary efficacy endpoint. However, there was a high rate of withdrawal from the study in the placebo group mainly due to worsening asthma. As the patient population was uncontrolled on high dose inhaled corticosteroid, this is not unexpected. The Aermony Respiclick treatment groups did show improvement in the primary endpoint that was associated with dose.

Overall, the efficacy for Aermony Respiclick 55 mcg, 113 mcg and 232 mcg was established in the clinical trial program.

The safety of Aermony Respiclick was evaluated in the 12-week Phase 3 and Phase 2 randomized clinical trials and in a 26-week open-label, active comparator safety trial. The most frequently reported adverse events across treatment groups were headaches, nasopharyngitis, upper respiratory tract infection, and oral candidiasis. There were generally no differences between doses. These adverse events are similar to those previously reported for inhaled fluticasone propionate. There were no deaths with placebo or Aermony Respiclick in any of the clinical trials. There were no effects on vital signs, clinical laboratory findings or ECG with Aermony Respiclick. Overall, the safety of Aermony Respiclick administered twice daily to patients 12 years and older with asthma was similar to other ICS and other inhaled products containing fluticasone propionate. The product monograph reflects the potential harms and the appropriate use of Aermony Respiclick.

Overall, the benefit/risk balance for Aermony Respiclick is considered favourable for the recommended indication.

A Notice of Compliance (NOC), pursuant to section C.08.004 of the Food and Drug Regulations, has been issued.