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
Phase 3
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
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
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: DrugTreatment
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
- Dreher M, Müller T. Add-on Therapy for Symptomatic Asthma despite Long-Acting Beta-Agonists/Inhaled Corticosteroid. Tuberc Respir Dis (Seoul). 2018 Jan;81(1):1-5. doi: 10.4046/trd.2017.0102. Epub 2017 Dec 13. Review.
- Costella S, Kirby M, Maksym GN, McCormack DG, Paterson NA, Parraga G. Regional pulmonary response to a methacholine challenge using hyperpolarized (3)He magnetic resonance imaging. Respirology. 2012 Nov;17(8):1237-46. doi: 10.1111/j.1440-1843.2012.02250.x.
- Kruger SJ, Niles DJ, Dardzinski B, Harman A, Jarjour NN, Ruddy M, Nagle SK, Francois CJ, Sorkness RL, Burton RM, Munoz del Rio A, Fain SB. Hyperpolarized Helium-3 MRI of exercise-induced bronchoconstriction during challenge and therapy. J Magn Reson Imaging. 2014 May;39(5):1230-7. doi: 10.1002/jmri.24272. Epub 2013 Sep 4.
- Kerwin E, Pascoe S, Bailes Z, Nathan R, Bernstein D, Dahl R, von Maltzahn R, Robbins K, Fowler A, Lee L. A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids. Respir Res. 2020 Jun 12;21(1):148. doi: 10.1186/s12931-020-01400-5.
- Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy. 2014 Apr 11;7:53-65. doi: 10.2147/JAA.S39119. eCollection 2014. Review.
- de Groot JC, Ten Brinke A, Bel EH. Management of the patient with eosinophilic asthma: a new era begins. ERJ Open Res. 2015 Sep 23;1(1). pii: 00024-2015. eCollection 2015 May. Review. Erratum in: ERJ Open Res. 2016 Aug 25;2(3):.
- Fain, Sean, Mark L. Schiebler, David G. McCormack, and Grace Parraga. 2010. “Imaging of Lung Function Using Hyperpolarized Helium-3 Magnetic Resonance Imaging: Review of Current and Emerging Translational Methods and Applications”. Journal of Magnetic Resonance Imaging. Wiley. doi:10.1002/jmri.22375.
- Aysola R, de Lange EE, Castro M, Altes TA. Demonstration of the heterogeneous distribution of asthma in the lungs using CT and hyperpolarized helium-3 MRI. J Magn Reson Imaging. 2010 Dec;32(6):1379-87. doi: 10.1002/jmri.22388. Review.
- Svenningsen, Sarah, Miranda Kirby, Danielle Starr, Harvey O Coxson, Nigel A M Paterson, David G McCormack, and Grace Parraga. 2013. “What Are Ventilation Defects in Asthma?”. Thorax. BMJ. doi:10.1136/thoraxjnl-2013-203711.
- Campana L, Kenyon J, Zhalehdoust-Sani S, Tzeng YS, Sun Y, Albert M, Lutchen KR. Probing airway conditions governing ventilation defects in asthma via hyperpolarized MRI image functional modeling. J Appl Physiol (1985). 2009 Apr;106(4):1293-300. doi: 10.1152/japplphysiol.91428.2008. Epub 2009 Feb 12.
- Samee S, Altes T, Powers P, de Lange EE, Knight-Scott J, Rakes G, Mugler JP 3rd, Ciambotti JM, Alford BA, Brookeman JR, Platts-Mills TA. Imaging the lungs in asthmatic patients by using hyperpolarized helium-3 magnetic resonance: assessment of response to methacholine and exercise challenge. J Allergy Clin Immunol. 2003 Jun;111(6):1205-11.
- Altes TA, Powers PL, Knight-Scott J, Rakes G, Platts-Mills TA, de Lange EE, Alford BA, Mugler JP 3rd, Brookeman JR. Hyperpolarized 3He MR lung ventilation imaging in asthmatics: preliminary findings. J Magn Reson Imaging. 2001 Mar;13(3):378-84.
- Tzeng YS, Lutchen K, Albert M. The difference in ventilation heterogeneity between asthmatic and healthy subjects quantified using hyperpolarized 3He MRI. J Appl Physiol (1985). 2009 Mar;106(3):813-22. doi: 10.1152/japplphysiol.01133.2007. Epub 2008 Nov 20.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention: Updated 2017. (2017).
- Fain S, Schiebler ML, McCormack DG, Parraga G. Imaging of lung function using hyperpolarized helium-3 magnetic resonance imaging: Review of current and emerging translational methods and applications. J Magn Reson Imaging. 2010 Dec;32(6):1398-408. doi: 10.1002/jmri.22375.
- de Groot JC, Ten Brinke A, Bel EH. Management of the patient with eosinophilic asthma: a new era begins. ERJ Open Res. 2015 Sep 23;1(1):00024-2015. doi: 10.1183/23120541.00024-2015. eCollection 2015 May. Erratum In: ERJ Open Res. 2016 Aug 25;2(3):
- Altes TA, Powers PL, Knight-Scott J, Rakes G, Platts-Mills TA, de Lange EE, Alford BA, Mugler JP 3rd, Brookeman JR. Hyperpolarized 3He MR lung ventilation imaging in asthmatics: preliminary findings. J Magn Reson Imaging. 2001 Mar;13(3):378-84. doi: 10.1002/jmri.1054.
- Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy. 2014 Apr 11;7:53-65. doi: 10.2147/JAA.S39119. eCollection 2014.
- Samee S, Altes T, Powers P, de Lange EE, Knight-Scott J, Rakes G, Mugler JP 3rd, Ciambotti JM, Alford BA, Brookeman JR, Platts-Mills TA. Imaging the lungs in asthmatic patients by using hyperpolarized helium-3 magnetic resonance: assessment of response to methacholine and exercise challenge. J Allergy Clin Immunol. 2003 Jun;111(6):1205-11. doi: 10.1067/mai.2003.1544.
- Dreher M, Muller T. Add-on Therapy for Symptomatic Asthma despite Long-Acting Beta-Agonists/Inhaled Corticosteroid. Tuberc Respir Dis (Seoul). 2018 Jan;81(1):1-5. doi: 10.4046/trd.2017.0102. Epub 2017 Dec 13.
- Aysola R, de Lange EE, Castro M, Altes TA. Demonstration of the heterogeneous distribution of asthma in the lungs using CT and hyperpolarized helium-3 MRI. J Magn Reson Imaging. 2010 Dec;32(6):1379-87. doi: 10.1002/jmri.22388.
- Dr. Grace Parraga 2022. "Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04651777.
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