A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS)

Last updated: June 28, 2022
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

N/A

Clinical Study ID

TX302634
  • Ages 12-80
  • All Genders

Study Summary

Add-on medication for patients with poorly controlled asthma requiring frequent hospitalization or steroid treatment to control asthma symptoms, despite being on regular asthma controller medications.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with Asthma > 1 year
  • Currently taking 2 inhalers for asthma (or one inhaler containing two medications)
  • Asthma exacerbation within the past year requiring steroid treatment or hospitalization
  • Body Mass Index <40
  • Men and Women of childbearing potential must agree to appropriate birth control measures

Exclusion

Exclusion Criteria:

  • Diagnosed with life threatening asthma condition
  • History of drug/alcohol abuse within the past year
  • Current untreated cancer
  • Smoking history >10 pack years (Packs per day x # years smoked)
  • Diagnosed with other pulmonary conditions

Study Design

Study Start date:
June 01, 2022
Estimated Completion Date:

Study Description

Connect with a study center

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York 12553
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.