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Bronchodilator

Treatment sequence BBA for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a Forced expiratory volume (FEV)1 ≥ 80% of the predicted normal value and an FEV1/FVC> 70% regarding age, height, and ethnicity at the screening visit.
Female participants must have a negative pregnancy test at screening and on admission and must not be lactating.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (≤ 28 days to day -2) until follow-up phone call (within 3 to 7 days post final dose)
Awards & highlights

Study Summary

This trial tests how safe and effective two different inhalers are for treating respiratory conditions in healthy adults.

Who is the study for?
This trial is for healthy men and women aged 18-60, not able to bear children or pregnant, with a BMI of 18-30 kg/m^2 and weight between 50-120 kg. They must have good lung function (FEV1 ≥80% predicted normal) and be able to use an inhaler correctly after training.Check my eligibility
What is being tested?
The study is testing the biochemical similarity of Budesonide and Albuterol in metered dose inhalers using two different propellants: HFA (hydrofluoroalkane) versus HFO (hydrofluoroolefin).See study design
What are the potential side effects?
Potential side effects may include throat irritation, coughing, nervousness, restlessness, tremors, changes in taste or dry mouth from the inhalers. These are common with respiratory medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function tests are within normal range for my age, height, and ethnicity.
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I am not pregnant, not breastfeeding, and have a negative pregnancy test.
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My BMI is between 18 and 30, and I weigh between 50kg and 120kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (≤ 28 days to day -2) until follow-up phone call (within 3 to 7 days post final dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (≤ 28 days to day -2) until follow-up phone call (within 3 to 7 days post final dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Maximum plasma drug concentration (Cmax)
Secondary outcome measures
Apparent total body clearance (CL/F)
Apparent volume of distribution during the terminal phase (Vz/F)
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment sequence BBAExperimental Treatment2 Interventions
Participants will receive Treatment B, followed by Treatment B, followed by Treatment A, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration.
Group II: Treatment sequence BABExperimental Treatment2 Interventions
Participants will receive Treatment B, followed by Treatment A, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration.
Group III: Treatment sequence ABBExperimental Treatment2 Interventions
Participants will receive Treatment A, followed by Treatment B, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,609 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research venture open to geriatric individuals?

"The age requirement for this study is between 18 and 60 years of age."

Answered by AI

Has the BAB medication regimen been authorized by the FDA?

"Due to the limited data surrounding Treatment sequence BAB, we have assigned it a safety score of 1 on our assessment scale. As this is Phase I trial, further research must be conducted before efficacy can be determined."

Answered by AI

What is the scope of enrollment for this research initiative?

"Affirmative, the information found on clinicaltrials.gov indicates that this trial is actively searching for volunteers. The study was launched on November 16th 2023 and has since been revised as of December 12th 2023. A total 66 participants are needed to be enrolled from 1 site."

Answered by AI

What are the intended outcomes of this experiment?

"According to the sponsor, AstraZeneca, the primary outcome of this experiment will be Maximum plasma drug concentration (Cmax) over a Day 1 and Day 2 period. Secondary outcomes that are also being measured include Ratio Area under plasma concentration-time curve from time 0 to infinity (AUCinf), Apparent total body clearance (CL/F), and Ratio Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)."

Answered by AI

Are additional participants being accepted for this experiment?

"Indeed, the information on clinicaltrials.gov confirms that this medical experiment is presently recruiting participants. It was initially posted on November 16th 2023 and has since been updated as of December 12th 2023. 66 patients need to be collected from a singular medical centre."

Answered by AI

Are there any restrictions on who may participate in this experiment?

"This clinical trial is accepting 66 participants, aged 18 to 60 years old who are deemed healthy, meeting the following criteria: non-childbearing adult males and females with suitable venous access for cannulation or repeated venipuncture; negative pregnancy test during screening and admission; body mass index between 18 and 30 kg/m^2, weighing 50-120kg respectively; Forced Expiratory Volume (FEV)1 at ≥ 80% of predicted normal values as well as an FEV1/FVC> 70%; successful inhalation technique training using a metered dose inhaler."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.
2023. "Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139991.
~0 spots leftby May 2024
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