A 12-week, Randomized, Double-Blind, Phase 4 Study Evaluating the Effect of AIRSUPRA Compared to Albuterol Administered as Needed on Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization in Adults With Mild Asthma

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma. Study details include: * The study duration will be up to 15 weeks. * The treatment duration will be 12 weeks. * The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

∙ Informed Consent

∙ 1 Capable of giving signed informed consent as described in the protocol which included compliance with the requirements and restrictions listed in the ICF and protocol

∙ Type of Participant and Disease Characteristics 3 Diagnosis of asthma, by a prescribing health care professional 4 ≥ 2 prescriptions for a SABA inhaler in the past 12 months prior to Visit 1 (and the expectation that the participant will probably use their rescue inhaler ≥ 2 days per week as this is required at Visit 2 for randomization following the Lead-in Period) 5 FeNO ≥ 25 ppb at Visit 1

∙ Sex and Contraceptive/Barrier Requirements 7 Female participants: Females must be not of childbearing potential or using a form of birth control as defined below:

• Females not of childbearing potential are defined as females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. The following age-specific requirements apply:

‣ Females \< 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.

⁃ Females ≥ 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.

• Female participants of childbearing potential must use a highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 14 days after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.

‣ All females of childbearing potential must have a negative pregnancy test result at Visit 1.

⁃ Females \< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.

• Highly effective birth control methods are listed below:

‣ Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).

⁃ Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:

• Oral

• Intravaginal

• Transdermal

‣ Progestogen-only hormonal contraception associated with inhibition of ovulation:

• Oral

• Injectable

• Implantable

‣ Intrauterine device or intrauterine hormone-releasing system

⁃ Bilateral tubal occlusion

⁃ Male partner sterilization/vasectomy with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant. The documentation on male sterility can come from the site personnel's review of participant's medical records, medical examination and/or semen analysis or medical history interview provided by her or her partner.

‣ 8 Negative pregnancy test (urine) for female participants of childbearing potential at Visit 1.

∙ Randomization Criteria 5.1.1 at Visit 2 (Week 0)

⁃ Symptoms requiring rescue medication use for a minimum of 2 days per week for the last 14 days during the Lead-in Period (minimum 4 uses total)

⁃ At least 80% overall compliance rate for performing daily FeNO and spirometry assessments and completing the twice-daily asthma symptom and rescue medication use diary during the Lead-in Period.

Locations
United States
Arizona
Research Site
RECRUITING
Phoenix
Research Site
RECRUITING
Tucson
California
Research Site
RECRUITING
Lancaster
Research Site
RECRUITING
San Diego
Florida
Research Site
RECRUITING
Cape Coral
Research Site
RECRUITING
Lake Worth
Research Site
WITHDRAWN
Tampa
Georgia
Research Site
RECRUITING
Columbus
Idaho
Research Site
RECRUITING
Boise
Indiana
Research Site
RECRUITING
Plainfield
Missouri
Research Site
RECRUITING
St Louis
North Carolina
Research Site
WITHDRAWN
Raleigh
New Jersey
Research Site
RECRUITING
Riverdale
Oklahoma
Research Site
RECRUITING
Oklahoma City
Pennsylvania
Research Site
RECRUITING
Pottstown
South Carolina
Research Site
RECRUITING
North Charleston
Texas
Research Site
RECRUITING
El Paso
Research Site
RECRUITING
Houston
Research Site
RECRUITING
Waco
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2025-11-10
Participants
Target number of participants: 100
Treatments
Experimental: Group 1 - Participants randomized to receive albuterol/budesonide
Participants will be randomized based on Visit 1 FeNO levels (\< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy.
Active_comparator: Group 2 - Participants randomized to receive albuterol
Participants will be randomized based on Visit 1 FeNO levels (\< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Fortrea

This content was sourced from clinicaltrials.gov

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