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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05755906
Other study ID # D5982C00005
Secondary ID 2021-003334-36
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 27, 2023
Est. completion date January 8, 2025

Study information

Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.


Description:

This is a Phase III, randomized, double-blind, parallel group, multicenter study comparing Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI) 160/9.6 μg twice daily (BID) to Budesonide MDI 160 μg (BD MDI), over 12 weeks. The study population will consist of adult and adolescent participants with asthma who remain inadequately controlled, as demonstrated by an Asthma Control Questionnaire (ACQ)-7 total score ≥1.5, despite treatment with low dose inhaled corticosteroid (ICS) or ICS/long-acting beta2-agonist (LABA). This study is to assess the benefits and safety of BFF MDI on lung function and asthma health-related quality of life. This study will be conducted at approximately 90 sites worldwide and will randomize approximately 340 adult and adolescent participants.


Recruitment information / eligibility

Status Recruiting
Enrollment 340
Est. completion date January 8, 2025
Est. primary completion date January 8, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 80 Years
Eligibility Inclusion Criteria 1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females of childbearing potential should be using highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma = 6 months prior to Visit 1, according to GINA guidelines [GINA 2021]. Healthcare records for one year prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants. 3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with allowed ICS doses, for at least 8 weeks prior to Visit 1. 4. ACQ-7 total score = 1.5 at Visits 1 and 4. 5. A pre-bronchodilator/pre-dose FEV1 < 90% predicted normal value at Visits 1, 2, and 3 and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization). 6. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of = 12% and = 200 mL for participants = 18 years of age OR a post-albuterol increase in FEV1 of = 12% for participants 12 to < 18 years of age either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3, if repeat testing is necessary. 7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that has not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit. 8. Asthma stability during run-in based on Investigator discretion using the symptom worsening assessment defined in Section 8.1.2.8 as a guideline. 9. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol. 10. Demonstrate acceptable MDI administration technique. 11. eDiary compliance = 70% during screening, defined as completing the daily eDiary and answering "Yes" to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization. Exclusion criteria 1. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s). 2. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period. 3. Hospitalization for asthma within 8 weeks of Visit 1. 4. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis. 5. Known history of drug or alcohol abuse within 12 months of Visit 1. 6. Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the skin are not exclusionary. 7. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in this protocol is prohibited for use during study duration. 8. Previous or current randomization into studies within the AEROSPHERE program including KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001). 9. Use of a nebulizer or a home nebulizer for receiving asthma medications. Note: Acute use of a nebulizer for an asthma exacerbation during hospitalization is allowed as long as there is no occurrence within 8 weeks of Visit 1. 10. Do not meet the stable dosing period prior to Visit 1 or unable to abstain from protocol-defined prohibited medications during Screening and Treatment Periods. 11. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg, vector, lipid nanoparticle) =7 days prior to Visit 1 (from last vaccination or booster dose). 12. Participants with known hypersensitivity to beta2-agonists, corticosteroids, or any component of the MDI. 13. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study. 14. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 15. Planned hospitalization during the study. 16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18. Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions and requirements. 19. For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BFF MDI 160/9.6 µg BID (320/19.2µg/day)
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 µg BID (320/19.2µg/day)
BD MDI 160 µg BID (320 µg/day)
Budesonide (BD) metered-dose inhaler (MDI), 160 µg BID (320 µg/day)

Locations

Country Name City State
Canada Research Site Ajax Ontario
Canada Research Site Kamloops British Columbia
Canada Research Site Kelowna British Columbia
Canada Research Site Montreal Quebec
Canada Research Site Penticton British Columbia
Canada Research Site Quebec
Canada Research Site Quebec
Canada Research Site Toronto Ontario
Canada Research Site Winchester Ontario
Canada Research Site Windsor Ontario
Canada Research Site Winnipeg Manitoba
Czechia Research Site Jindrichuv Hradec
Czechia Research Site Kralupy nad Vltavou
Czechia Research Site Louny
Czechia Research Site Lovosice
Czechia Research Site Miroslav
Czechia Research Site Praha 11
Czechia Research Site Praha 9
Czechia Research Site Rudná
Czechia Research Site Teplice
Czechia Research Site Varnsdorf
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Geesthacht
Germany Research Site Hamburg
Germany Research Site Hannover
Germany Research Site Landsberg
Germany Research Site Leipzig
Germany Research Site Schleswig
Germany Research Site Wiesbaden
Korea, Republic of Research Site Daegu
Korea, Republic of Research Site Guri-si
Korea, Republic of Research Site Jeonju
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Ulsan
Malaysia Research Site Alor Setar
Malaysia Research Site George Town
Malaysia Research Site Ipoh
Malaysia Research Site Kajang
Malaysia Research Site Kota Bharu
Malaysia Research Site Kuala Lumpur
Malaysia Research Site Kuala Terengganu
Malaysia Research Site Sarawak Miri
Malaysia Research Site Seremban
Philippines Research Site Iloilo City
Philippines Research Site Manila
Philippines Research Site Manila
Philippines Research Site Marilao
South Africa Research Site Durban
South Africa Research Site Durban
South Africa Research Site Newton
South Africa Research Site Pretoria
South Africa Research Site Tygervalley
United States Research Site Amarillo Texas
United States Research Site American Fork Utah
United States Research Site Andrews Texas
United States Research Site Ann Arbor Michigan
United States Research Site Annapolis Maryland
United States Research Site Atlanta Georgia
United States Research Site Atlanta Georgia
United States Research Site Austin Texas
United States Research Site Bakersfield California
United States Research Site Beaumont Texas
United States Research Site Bellevue Nebraska
United States Research Site Boerne Texas
United States Research Site Bountiful Utah
United States Research Site Chandler Arizona
United States Research Site Charlotte North Carolina
United States Research Site Cheney Washington
United States Research Site Chicago Ridge Illinois
United States Research Site Choctaw Oklahoma
United States Research Site Columbus Ohio
United States Research Site Cutler Bay Florida
United States Research Site Dallas Texas
United States Research Site DeBary Florida
United States Research Site DeLand Florida
United States Research Site Detroit Michigan
United States Research Site Edmond Oklahoma
United States Research Site El Paso Texas
United States Research Site Encinitas California
United States Research Site Farmington Hills Michigan
United States Research Site Fayetteville North Carolina
United States Research Site Forney Texas
United States Research Site Fresno California
United States Research Site Gastonia North Carolina
United States Research Site Gilroy California
United States Research Site Glendale Arizona
United States Research Site Hatboro Pennsylvania
United States Research Site Henderson Nevada
United States Research Site Hialeah Florida
United States Research Site Huntington Beach California
United States Research Site Huntington Beach California
United States Research Site Kalispell Montana
United States Research Site Kansas City Missouri
United States Research Site Katy Texas
United States Research Site Kernersville North Carolina
United States Research Site Las Vegas Nevada
United States Research Site Las Vegas Nevada
United States Research Site Lexington Kentucky
United States Research Site Los Angeles California
United States Research Site Los Angeles California
United States Research Site Los Angeles California
United States Research Site Marrero Louisiana
United States Research Site Mesa Arizona
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Milwaukee Wisconsin
United States Research Site Missoula Montana
United States Research Site New Windsor New York
United States Research Site Newport Beach California
United States Research Site North Dartmouth Massachusetts
United States Research Site North Las Vegas Nevada
United States Research Site Northridge California
United States Research Site Oklahoma City Oklahoma
United States Research Site Omaha Nebraska
United States Research Site Pittsburgh Pennsylvania
United States Research Site Plantation Florida
United States Research Site Portsmouth New Hampshire
United States Research Site Raleigh North Carolina
United States Research Site Rolla Missouri
United States Research Site Sacramento California
United States Research Site Saint Louis Missouri
United States Research Site San Antonio Texas
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site San Jose California
United States Research Site Schenectady New York
United States Research Site Skillman New Jersey
United States Research Site South Bend Indiana
United States Research Site Tampa Florida
United States Research Site Teaneck New Jersey
United States Research Site Thousand Oaks California
United States Research Site Tucson Arizona
United States Research Site Ventura California
United States Research Site Victoria Texas
United States Research Site Waco Texas
United States Research Site Walnut Creek California
United States Research Site Wheat Ridge Colorado
United States Research Site White Marsh Maryland

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Korea, Republic of,  Malaysia,  Philippines,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12 United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12 at week 12
Secondary US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 12 US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 12 at week 12
Secondary Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks over 12 Weeks
Secondary Percentage of responders in ACQ-7 (= 0.5 decrease equals response) at Week 12 Percentage of responders in ACQ-7 (= 0.5 decrease equals response) at Week 12 at Week 12
Secondary Percentage of responders in ACQ-5 (= 0.5 decrease equals response) at Week 12 Percentage of responders in ACQ-5 (= 0.5 decrease equals response) at Week 12 at Week 12
Secondary Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (= 0.5 increase equals response) at Week 12 Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12)(= 0.5 increase equals response) at Week 12 at Week 12
Secondary Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 (within group comparison) on Day 1
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