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) / AV003

Updated on 23 November 2020


A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma (MANDALA), new combination for as needed administration in patients with asthma




Study related procedures and study medication will be provided to study participants at no cost, and there is compensation provided for time and travel.

Condition Asthma
Clinical Study IdentifierTX228646
Last Modified on23 November 2020


Yes No Not Sure

Inclusion Criteria

LTRA, LAMA, or theophylline Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to <90% predicted normal value for adults and adolescents, and ≥60 to <100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA) Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry
One re-test for reversibility testing is allowed within the screening period in advance of Visit 2 Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1 Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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