Trial Set Up
How long was the treatment phase of the BATURA Trial?
BATURA ran for a minimum of 12 weeks but went up to 52 weeks
What age populations was included in the BATURA Trial?
equal to or greater than 12 years of age
What were the annualized asthma exacerbations rate results in BATURA?
54% reduction in annualized asthma exacerbations rate with AIRSUPRA
What were the 3 most common adverse effects for AIRSUPRA in the MANDALA Trial?
headache, oral candidiasis, and cough
How many patients have been studied across the clinical evidence programs doe AIRSUPRA? (Denali, Mandala, and Batura)
6400 patients total
In the BATURA trial, what percentage of patients were on SABA alone rescue as their pre-study asthma medication?
In the BATURA trial, 74% of patients were on SABA alone rescue
What was the Primary Efficacy Endpoint of BATURA and it’s results?
AIRSUPRA significantly reduced the severe exacerbation risk by 46%
Time to first severe asthma exacerbation. An exacerbation was defined as severe if at lease one of the following occurred:
1. Temporary burst of SCS for > 3 consecutive days or single steroid injection to treat worsening asthma symptoms
2. ER or UC visit due to asthma that required SCS
3. Inpatient hospitalization due to asthma lasting 24+ hours
4. Death
In the MANDALA Trial, what was the average daily use of AIRSUPRA vs Albuterol?
The overall pattern of as-needed use of trial medications was similar in all groups with increased use around the time of clinical deterioration. On the majority of days patients used 2 or fewer inhalations.
In the BATURA Trial, what was the median time since asthma diagnosis?
25 years
In the BATURA Trial, what percentage of patients did NOT have an exacerbation in the previous 12 months?
89% of patients had ZERO exacerbations within the past 12 months
What patient population is covered in the indication for AIRSUPRA?
Airsupra is indicated for the as needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.
In the MANDALA Trial, what PERCENTAGE of days on average did patients report using their background ICS containing maintenance therapy?
~75%
In the BATURA trial key demographics, what was the breakdown of race?
70% caucasian
18% black/african american
12% other
In the BATURA Trial, what percentage of patients were on SABA alone rescue + low dose ICS or LTRA as pre-study asthma medication?
26% of patients were on SABA alone rescue plus low dose ICS or LTRA
What was the mean annualized total SCS dose results?
AIRSUPRA significantly reduced the mean annualized total SCS dose by 63%
In the MANDALA Trial, what percentage of patients had at least one severe exacerbation in the previous 12 months?
78.5%
How many Albuterol prescriptions were the “SABA alone” patients allowed to have filled to be included in BATURA Trial?
greater than or equal to 2 prescriptions for a SABA inhaler within 12 months.
Name ONE of the Key Exclusion Criteria for BATURA the patient population
1. Significant lung disease other than asthma or any significant disease
2. Hospitalization due to asthma in the last 3 months prior to enrollment or ICU submission with life-threatening asthma at anytime
3. Use of LABA, theophylline, anticholinergics, from one, or medium/high-dose daily ICS as regular maintenance asthma therapy in 3 months prior
4. Any use of SCS for the treatment of asthma or any other condition in 6 weeks prior
5. Prophylactic use of a SABA to prevent EIB only
In BATURA, what was the average daily use of AIRSUPRA vs Albuterol?
The average daily rescue dose was similar for AIRSUPRA and albuterol: an average of 1.5 inhalations for AIRSUPRA and 1.8 inhalations for albuterol. In majority of study days, patients used 2 or less inhalations of AIRSUPRA. More than 8 inhalations were used on 2% of study days.
In the MANDALA Trial, what was the inclusion requirements around the use of maintenance ICS at baseline?
to be eligible for MANDALA, patients with asthma HAD to be using ICS as maintenance treatment.