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BGF MDI HFO 320/14.4/9.6μg for Chronic Obstructive Pulmonary Disease

Research Site, Mersin, Turkey
Chronic Obstructive Pulmonary DiseaseBGF MDI HFO 320/14.4/9.6 μg - Drug
Eligibility
40 - 80
All Sexes

Study Summary

This trial will compare the safety of two inhalers for COPD over 12-52 weeks.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Treatment A (BGF MDI HFO with oral activated charcoal)
1
Treatment Sequence AB
1
HNC364

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: Week 4, 8 and 52 (if attending 56 weeks study)

Week 56
Number (and percentage) of participants with potentially clinically significant changes in Blood Pressure
Number (and percentage) of participants with potentially clinically significant changes in body temperature
Body Weight Changes
Number (and percentage) of participants with potentially clinically significant changes in respiratory rate
Week 56
Number (and percentage) of participants with adverse Events - AEs (including SAEs, DAEs, AEOSIs, non-serious AEs)
Week 12
Electrocardiogram
Week 56
Urinalysis
Week 56
Electrocardiogram

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Treatment A (BGF MDI HFO with oral activated charcoal)
1
Treatment Sequence AB
1
HNC364

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

BGF MDI HFA 320/14.4/9.6 μg
1 of 2
BGF MDI HFO 320/14.4/9.6μg
1 of 2

Active Control

Experimental Treatment

542 Total Participants · 2 Treatment Groups

Primary Treatment: BGF MDI HFO 320/14.4/9.6μg · No Placebo Group · Phase 3

BGF MDI HFO 320/14.4/9.6μg
Drug
Experimental Group · 1 Intervention: BGF MDI HFO 320/14.4/9.6 μg · Intervention Types: Drug
BGF MDI HFA 320/14.4/9.6 μg
Drug
ActiveComparator Group · 1 Intervention: BGF MDI HFA 320/14.4/9.6 μg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 4, 8 and 52 (if attending 56 weeks study)

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,057 Previous Clinical Trials
240,390,716 Total Patients Enrolled

Eligibility Criteria

Age 40 - 80 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have smoked for at least 10 years, averaging one pack of cigarettes per day.

Who else is applying?

What state do they live in?
Florida33.3%
Oregon33.3%
Arizona33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
How many prior treatments have patients received?
3+100.0%
Why did patients apply to this trial?
  • "I have tried several inhalers but my lung capacity is slowly going down. It is presently at 47% capacity!"
References

Frequently Asked Questions

Can seniors participate in this research?

"Enrolment for this particular trial is restricted to patients aged 40 to 80. However, there are other 36 trials for patients under 18 and 479 trials for those over 65." - Anonymous Online Contributor

Unverified Answer

To whom is this treatment opportunity available?

"To take part in this experiment, individuals must have chronic obstructive airway disease and be between 40 and 80 years old. Currently, the trial is looking for 542 individuals in total." - Anonymous Online Contributor

Unverified Answer

Is this trial overseen by a large team or a small one?

"The 31 sites for this trial are located in various cities, including Clearwater, Ajax and Sarasota. It may be helpful to select the clinic nearest to you, to reduce the amount of travel required." - Anonymous Online Contributor

Unverified Answer

Has the FDA cleared BGF MDI HFO 320/14.4/9.6μg for general use?

"BGF MDI HFO 320/14.4/9.6μg is in Phase 3 of clinical trials, which suggests that there is some evidence of efficacy and that the safety of the drug has been supported by multiple rounds of testing." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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