Health Trials

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

An event-driven, Phase III study to evaluate the efficacy and safety of BDA MDI compared with AS MDI in reducing the risk of a severe asthma exacerbation in symptomatic Chinese adults with asthma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented physician-diagnosed asthma for at least 12 months prior to Visit 1

Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1

Pre-bronchodilator FEV1 of ≥ 40% to < 90% predicted normal value for adults.

Documented reversibility to albuterol

Disqualifiers

Chronic obstructive pulmonary disease or other significant lung disease

Oral/SCS use (any dose) within 6 weeks before Visit 1

Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1

Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • Budesonide/Albuterol metered dose inhaler, MDI

    Combination product

    Combination Product (Drug + Device)

  • Albuterol sulfate metered dose inhaler, MDI

    Combination product

    Combination Product (Drug + Device)

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: BDA MDIExperimental treatment 1 intervention
Group B: AS MDIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first severe asthma exacerbation

The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbation risk over the 24 to 52 week treatment period.

Time frame
24 to 52 weeks

Secondary outcomes

1

Severe asthma exacerbation rate (annualized)

The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure

Time frame
24 to 52 weeks
2

Total SCS exposure over the treatment period

The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure

Time frame
24 to 52 weeks
3

ACQ-5 responder (≥ 0.5 decrease)

The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24

Time frame
Week 24
4

AQLQ+12 responder (≥ 0.5 increase)

The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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