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Corticosteroid

Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator for Chronic Obstructive Pulmonary Disease

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening up to follow-up phone call (3 to 7 days post final dose) [approximately 55 days]
Awards & highlights

Study Summary

This trial will compare the effects of two different types of inhalers on healthy male and female participants.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to follow-up phone call (3 to 7 days post final dose) [approximately 55 days]
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to follow-up phone call (3 to 7 days post final dose) [approximately 55 days] 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 zero to infinity (AUCinf)
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
Maximum observed plasma (peak) drug concentration (Cmax)
Secondary outcome measures
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuatorExperimental Treatment2 Interventions
Participants will receive Reference formulation in 1 of 3 possible treatment sequences: ABB, BAB, or BBA. The reference formulation will be administered during 2 of the 3 treatment periods in order to estimate intra-subject variability.
Group II: Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuatorExperimental Treatment2 Interventions
Participants will receive Test formulation in 1 of 3 possible treatment sequences: ABB, BAB, or BBA. The reference formulation will be administered during 2 of the 3 treatment periods in order to estimate intra-subject variability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment A: BGF MDI HFO
2022
Completed Phase 1
~110
Treatment B: BGF MDI HFA
2022
Completed Phase 1
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,678 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,718 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals eligible to participate in this experiment at the moment?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical study is currently enrolling participants with a start date of October 11th 2022 and an update on November 29th 2022. 108 people must be recruited from 2 distinct sites in order for the trial to proceed as planned."

Answered by AI

Does this research involve participants aged 25 or above?

"This trial is limited to patients aged 18-60. For those younger than that, there are 14 other clinical trials available, and 333 for the elderly population above 65 years old."

Answered by AI

How many participants is this medical trial taking on?

"Correct. According to clinicaltrials.gov, this trial is actively enrolling patients; the listing was originally posted on October 11th 2022 and recently updated on November 29th that year. The research requires 108 participants from two separate medical facilities."

Answered by AI

Has the Food and Drug Administration sanctioned Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator?

"With Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator, the assessment of safety is low due to its current Stage 1 status with limited clinical data on efficacy and safety available for review."

Answered by AI

Do I qualify for involvement in this experimental protocol?

"This trial is recruiting 108 individuals with a chronic respiratory disorder to participate. Participation in this study necessitates being between 18 and 60 years old, having an appropriate BMI (18-35 kg/m2), providing signed informed consent, presenting negative results on a pregnancy test, displaying reliable inhalation technique of the correct medication delivery device after training, exhibiting a FEV1 ≥ 80% of the predicted normal value and an FEV1/FVC > 70%, and weighing no less than 50kg nor more than 120 kg."

Answered by AI

What is the ambition of this exploration?

"This trial will assess a wide range of outcomes, with the primary assessment being Maximum Observed Plasma (Peak) Drug Concentration (Cmax). The secondary endpoints include Half-life Associated With Terminal Slope (λz), Percentage of Participants With Potentially Clinically Significant Changes In Laboratory Values (Hematology, Clinical Chemistry, and Urinalysis), as well as Apparent Total Body Clearance Of Drug From Plasma After Extravascular Administration (CL/F); all measured over two consecutive days."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA
2022. "A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05569421.
~43 spots leftby Apr 2025
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