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Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

NCT04609878 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2274

Last updated 2025-04-20

No results posted yet for this study

Summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

Conditions

Interventions

DRUG

BGF MDI 320/28.8/9.6 μg

Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler

DRUG

BGF MDI 320/14.4/9.6 μg

Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler

DRUG

BFF MDI 320/9.6 μg

Budesonide and formoterol fumarate metered dose inhaler

DRUG

BFF pMDI 320/9 μg

Budesonide/formoterol fumarate pressurized metered dose inhaler

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2025-03-21
Completion
2025-03-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Hungary
  • India
  • Italy
  • Japan
  • New Zealand
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Vietnam

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 NCT04609878 on ClinicalTrials.gov