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PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction

NCT05555290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-01-27

Study results available
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Summary

A 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

Conditions

Interventions

COMBINATION_PRODUCT

PT027

When administered PT027, participants will receive 2 actuations of albuterol- budesonide per dose administered as oral inhalations.

COMBINATION_PRODUCT

PT007

When administered PT007, participants will receive 2 actuations of albuterol administered as oral inhalations.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2024-11-18
Completion
2024-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555290 on ClinicalTrials.gov