ACTIVE_NOT_RECRUITING

A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).

Official Title

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Dose Range-Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults With Uncontrolled Asthma at Risk of Exacerbations (LEVANTE)

Quick Facts

Study Start:2024-08-30
Study Completion:2026-02-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06529419

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Njira Lugogo
PRINCIPAL_INVESTIGATOR
Univeristy of Michigan Hospital, Ann Arbor, MI, US

Study Locations (Sites)

Research Site
Mesa, Arizona, 85213
United States
Research Site
Huntington Beach, California, 92647
United States
Research Site
La Mesa, California, 91942
United States
Research Site
Laguna Niguel, California, 92677
United States
Research Site
Lancaster, California, 93534
United States
Research Site
Long Beach, California, 90815
United States
Research Site
San Jose, California, 95117
United States
Research Site
New Haven, Connecticut, 06510
United States
Research Site
DeBary, Florida, 32713
United States
Research Site
Jacksonville, Florida, 32216
United States
Research Site
Jensen Beach, Florida, 34957
United States
Research Site
Largo, Florida, 33777
United States
Research Site
Miami, Florida, 33135
United States
Research Site
Miami Lakes, Florida, 33014
United States
Research Site
Tampa, Florida, 33607
United States
Research Site
Lilburn, Georgia, 30047
United States
Research Site
Savannah, Georgia, 31406
United States
Research Site
Chicago, Illinois, 60616
United States
Research Site
Winfield, Illinois, 60190
United States
Research Site
Ames, Iowa, 50010
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Baltimore, Maryland, 21237
United States
Research Site
Methuen, Massachusetts, 01844
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Las Vegas, Nevada, 89102
United States
Research Site
Las Vegas, Nevada, 89119
United States
Research Site
Riverdale, New Jersey, 07457
United States
Research Site
Middletown, New York, 10941
United States
Research Site
Greenville, North Carolina, 27834
United States
Research Site
Winston-Salem, North Carolina, 27104
United States
Research Site
Beavercreek, Ohio, 45431
United States
Research Site
Lima, Ohio, 45801
United States
Research Site
Oklahoma City, Oklahoma, 73120
United States
Research Site
Horsham, Pennsylvania, 19044
United States
Research Site
Austin, Texas, 78704
United States
Research Site
McKinney, Texas, 75069
United States
Research Site
Mesquite, Texas, 75149
United States
Research Site
Pearland, Texas, 77584
United States
Research Site
San Antonio, Texas, 78215
United States
Research Site
American Fork, Utah, 84003
United States
Research Site
Roy, Utah, 84067
United States
Research Site
Salt Lake City, Utah, 84124
United States
Research Site
Hampton, Virginia, 23666
United States
Research Site
Milwaukee, Wisconsin, 53228
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Njira Lugogo, PRINCIPAL_INVESTIGATOR, Univeristy of Michigan Hospital, Ann Arbor, MI, US

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-30
Study Completion Date2026-02-04

Study Record Updates

Study Start Date2024-08-30
Study Completion Date2026-02-04

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma