Study Summary
This trial will compare the effects of two different types of inhalers on healthy male and female participants.
- Chronic Obstructive Pulmonary Disease (COPD)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 14 Secondary · Reporting Duration: From Screening up to Follow-up Phone call (3 to 7 days post final dose) [approximately 55 days]
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator
1 of 2
Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator
1 of 2
Experimental Treatment
108 Total Participants · 2 Treatment Groups
Primary Treatment: Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator · No Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 60 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor