Participants with poorly controlled moderate to severe asthma for Asthma

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre, London, Canada
AsthmaFF/UMEC/VI - Drug
Eligibility
18 - 70
All Sexes

Study Summary

This trial will evaluate how effective a triple therapy inhaler is in treating asthma, using MRI, CT, lung function tests & questionnaires.

Treatment Effectiveness

Phase-Based Effectiveness

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

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: Day 42

Day 42
Change from baseline airway function measured using 129-Xenon MRI ventilation defect percent at the end of 6 weeks of treatment with FF/UMEC/VI 200/62.5/25ug once daily
Day 42
Change from baseline forced expiration volume in one second
Change from baseline forced oscillation technique
Change from baseline forced vital capacity
Change from baseline in asthma control
Change from baseline in asthma-related quality of life
Change from baseline in daily life and perceived well-being using the SGRQ.
Change from baseline lung clearance index
Change from baseline residual volume
Change from baseline total lung capacity
Explore univariate correlation and linear regression of MRI ventilation defect percent and FVC.
Explore univariate correlation and linear regression of MRI ventilation defect percent and asthma control as measured by the Asthma Control Questionnaire
Explore univariate correlation and linear regression of MRI ventilation defect percent and asthma-related quality of life as measured by the Asthma Quality of Life Questionnaire
Explore univariate correlation and linear regression of MRI ventilation defect percent and daily life and perceived well-being as measured by the St. George's Respiratory Questionnaire
Explore univariate correlation and linear regression of MRI ventilation defect percent and forced expiration volume in one second.
Explore univariate correlation and linear regression of MRI ventilation defect percent and forced oscillation technique
Explore univariate correlation and linear regression of MRI ventilation defect percent and forced vital capacity
Explore univariate correlation and linear regression of MRI ventilation defect percent and lung clearance index

Trial Safety

Phase-Based Safety

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

Side Effects for

FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI
2%Dyspnoea
2%Pneumonia
2%Chronic obstructive pulmonary disease
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03467425) in the FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI ARM group. Side effects include: Dyspnoea with 2%, Pneumonia with 2%, Chronic obstructive pulmonary disease with 2%.

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

1 Treatment Group

Participants with poorly controlled moderate to severe asthma
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Participants with poorly controlled moderate to severe asthma · No Placebo Group · Phase 3

Participants with poorly controlled moderate to severe asthma
Drug
Experimental Group · 1 Intervention: FF/UMEC/VI · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FF/UMEC/VI
2018
Completed Phase 4
~6430

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 42

Who is running the clinical trial?

Dr. Grace ParragaLead Sponsor
5 Previous Clinical Trials
454 Total Patients Enrolled
4 Trials studying Asthma
254 Patients Enrolled for Asthma
GlaxoSmithKlineIndustry Sponsor
4,674 Previous Clinical Trials
7,959,878 Total Patients Enrolled
289 Trials studying Asthma
409,885 Patients Enrolled for Asthma
Grace E Parraga, PhDPrincipal InvestigatorRobarts Research Institute, The University of Western Ontario
14 Previous Clinical Trials
1,333 Total Patients Enrolled
4 Trials studying Asthma
254 Patients Enrolled for Asthma

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Is this research open to elderly individuals?

"Participants who will be incorporated into this research must have attained majority status and not yet reached their seventieth birthday." - Anonymous Online Contributor

Unverified Answer

What risks do individuals with poorly-managed moderate to severe asthma pose?

"The safety of individuals with poorly managed moderate to severe asthma was rated a 3, as Phase 3 clinical trials have evidenced efficacy and demonstrated multiple rounds of data confirming its security." - Anonymous Online Contributor

Unverified Answer

Who is eligible for participation in this clinical research?

"Individuals between the ages of 18 and 70 who have been diagnosed with asthma are eligible to participate in this trial. Approximately 30 people will be admitted as participants." - Anonymous Online Contributor

Unverified Answer

To what extent is this trial limited in terms of participant size?

"Affirmative. The information available on clinicaltrials.gov confirms that the trial, which was initially posted on August 8th 2022, is currently recruiting participants. 30 patients are needed to join this single-site study." - Anonymous Online Contributor

Unverified Answer

Does this trial have any current openings for participants?

"Affirmative. The information available on clinicaltrials.gov implies that this clinical trial is currently searching for volunteers, with the original post dated 8/8/2022 and most recent update being 5/10/2023. 30 participants are required at 1 medical centre to complete the study objectives." - 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.