PT027 compared to PT007 in patients with asthma with mannitol-induced acute airway obstruction

Study identifier:D6930C00017

ClinicalTrials.gov identifier:NCT05555290

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

ALTA - ALbuterol/budesonide Treatment in Acute airway obstruction. A randomized, double-blind, 2-period, cross-over study evaluating efficacy and safety of repeated doses of PT027 compared to PT007 in patients with asthma and acute airway obstruction induced by repeated mannitol challenges

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

PT027, PT007

Sex

All

Estimated Enrollment

105

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Sept 2022
Estimated Primary Completion Date: 31 Dec 2024
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria