MANDALA study
Research type
Research Study
Full title
A Long-Term, Randomized, Double-Blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as needed in Response to Symptoms in Symptomatic Adults and Children 4 years of Age or Older with Asthma (MANDALA)
IRAS ID
256161
Contact name
Anna Danilewicz
Contact email
Sponsor organisation
Bond Avillion 2 Development LP
Eudract number
2018-003673-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
3 years, 4 months, 28 days
Research summary
Research Summary
There is a need to develop new asthma medications that can treat and potentially delay asthma attacks. This study will compare a combination of an anti-inflammatory controller and a reliever medicine administered via an inhaler (PT027) with a widely-used reliever medication (PT007) alone, in adults and children aged 4 years and above. When patients require treatment for frequent relief from symptoms, additional anti-inflammatory medication may be provided as separate medication. Participants aged 12 years and over will be allocated to one of three treatment groups; in addition, children (aged 4 years up to and including 11 years old) will be allocated to one of two treatment groups, but neither the participant nor the study doctor will know which group they are in. The purpose of this study is to discover if PT027 can prevent or reduce asthma attacks and delay further attacks compared to PT007 alone. Participants will continue to take their regular controller asthma medication and use PT027 as their reliever for asthma attacks. Participants will enter the study for a minimum of 24 weeks or until 570 total first severe asthma events have been reached across all participants, whichever occurs later. The information collected from this study may enable doctors to make better decisions about how to treat asthmatic patients, and may improve the future treatment of patients with asthma.
Summary of Research
Treatment with the investigational product, budesonide and albuterol sulfate (BDA) administered as needed by a metered dose inhaler (MDI), demonstrated statistically and clinically significant reductions in the risk of a severe asthma exacerbation, as assessed by time to first severe asthma exacerbation, compared with albuterol sulfate MDI, over the randomized treatment period (a minimum of 24 weeks). In subjects 12 years of age and older, the risk reduction was 27% for BDA MDI 160/180 micrograms compared with AS MDI 180 micrograms. In subjects 4 years of age and older, the risk reduction was 17% for BDA MDI 80/180 micrograms compared with AS MDI 180 micrograms. Overall, the study did not show any clinically important differences between the safety profiles of the BDA MDI 160/180 micrograms, BDA MDI 80/180 micrograms, and AS MDI 180 micrograms treatment groups. The side effects of BDA MDI were consistent with the well-known effects of the BDA MDI single components, budesonide and albuterol.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0072
Date of REC Opinion
21 Jun 2019
REC opinion
Further Information Favourable Opinion