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Corticosteroid

Treatment A (BGF MDI HFO with oral activated charcoal) 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 sae: screening (up to 28 days); ae: screening, day 1 and day 2 until follow-up visit (approximately 3 to 7 days post final dose) [approximately 55 days]
Awards & highlights

Study Summary

This trial will study the effects of two different types of propellants in an inhaler on the body, specifically how the drug is absorbed and how safe it is.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sae: screening (up to 28 days); ae: screening, day 1 and day 2 until follow-up visit (approximately 3 to 7 days post final dose) [approximately 55 days]
This trial's timeline: 3 weeks for screening, Varies for treatment, and sae: screening (up to 28 days); ae: screening, day 1 and day 2 until follow-up visit (approximately 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)
Plasma
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-actuator with oral activated charcoalExperimental Treatment2 Interventions
Subjects 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-actuator with oral activated charcoalExperimental Treatment2 Interventions
Subjects 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 with oral activated charcoal)
2022
Completed Phase 1
~110
Treatment B (BGF MDI HFA with oral activated charcoal)
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
4,267 Previous Clinical Trials
288,606,873 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.

Is Treatment A (BGF MDI HFO with oral activated charcoal) conducive to a safe patient experience?

"We have evaluated Treatment A (BGF MDI HFO with oral activated charcoal) and judged its safety to be a 1, indicating that there is limited data available which supports the efficacy of this treatment."

Answered by AI

Do I fulfill the requirements to join this medical experiment?

"This clinical trial has set the criteria for enrolment to include any adults aged 18-60 who suffer from chronic obstructive airway disease. A total of 108 participants are necessary in order to complete this medical research."

Answered by AI

To what extent is this clinical trial being populated by participants?

"Affirmative. Clinicaltrials.gov data highlights that this clinical trial is currently looking for individuals to participate, which was originally launched on July 29th 2022 and has seen its last update on October 6th 2022. A total of 108 patients are requested from one medical site."

Answered by AI

What are the core goals of this medical investigation?

"The primary endpoint, which will be assessed over a 48-hour period of each treatment cycle, is Area Under the Curve from time zero to infinity (AUCinf). Moreover, AstraZeneca's clinical trial also plans on evaluating secondary outcomes such as Percentage of subjects with clinically relevant changes in pulse rate; Percentage of subjects with noteworthy alterations in 12-lead ECGs; and Half life related to terminal slope (λz) on semi logarithmic concentration curves (t½λz), all pertaining to BGF MDI HFO/BGF MDI HFA combined with oral activated charcoal."

Answered by AI

Does this trial encompass geriatric patients?

"To be considered for this trial, participants must range in age from 18 to 60. In contrast, there are 14 trials designed specifically for those under the legal age and 333 studies open to seniors above 65 years old."

Answered by AI

Are any new participants being welcomed into this experiment?

"This medical trial is still recruiting participants, as evidenced by the data hosted on clinicaltrials.gov. The listing was first published July 29th 2022 and has recently been updated October 6th of that same year."

Answered by AI
~40 spots leftby Apr 2025