Study Summary
This triallooks at how two drugs compare in helping people with asthma on high-dose steroids.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Week 12
Week 12
Change from baseline in FEV1 Area Under the Curve from 0 to 12 hours post-dose (AUC0-12h) at Week 12 calculated as the difference of the values for CHF 1535 pMDI 800/24µg total daily dose (TDD) and CHF 718 pMDI 800µg TDD.
Change from baseline in peak FEV1 within the first 3 hours post-dose at Week 12 calculated as the difference of the values for CHF 1535 pMDI 800/24µg TDD and CHF 718 pMDI 800µg TDD.
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
CHF 718 pMDI
1 of 2
CHF 1535 pMDI
1 of 2
Active Control
Experimental Treatment
580 Total Participants · 2 Treatment Groups
Primary Treatment: CHF 1535 pMDI · No Placebo Group · Phase 3
CHF 1535 pMDI
Drug
Experimental Group · 1 Intervention: Beclomethasone Dipropionate/Formoterol Fumarate · Intervention Types: DrugCHF 718 pMDI
Drug
ActiveComparator Group · 1 Intervention: Beclomethasone Dipropionate · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Beclomethasone Dipropionate/Formoterol Fumarate
2017
N/A
~50
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
Who is running the clinical trial?
Chiesi Farmaceutici S.p.A.Lead Sponsor
181 Previous Clinical Trials
306,173 Total Patients Enrolled
64 Trials studying Asthma
224,335 Patients Enrolled for Asthma
Steven F. Weinstein, M.D.Principal InvestigatorAllergy and Asthma Specialists Medical Group and Research Center
Eligibility Criteria
Age 18 - 75 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a medical history of asthma for at least a year and it started before you turned 40 years old.
Who else is applying?
What state do they live in?
| California | 100.0% |
What site did they apply to?
| Chiesi Clinical Trial Site 840861 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "Really want to get my asthma under control"
References
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- Virchow JC, Backer V, de Blay F, Kuna P, Ljorring C, Prieto JL, Villesen HH. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Respir Med. 2015 May;109(5):547-56. doi: 10.1016/j.rmed.2015.01.012. Epub 2015 Feb 3.
- Lipworth B, Manoharan A, Anderson W. Unlocking the quiet zone: the small airway asthma phenotype. Lancet Respir Med. 2014 Jun;2(6):497-506. doi: 10.1016/S2213-2600(14)70103-1.
- Roland NJ, Bhalla RK, Earis J. The local side effects of inhaled corticosteroids: current understanding and review of the literature. Chest. 2004 Jul;126(1):213-9. doi: 10.1378/chest.126.1.213.
- Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006 Apr;100(4):616-21. doi: 10.1016/j.rmed.2005.08.012. Epub 2005 Oct 13.
- Forno E, Celedon JC. Asthma and ethnic minorities: socioeconomic status and beyond. Curr Opin Allergy Clin Immunol. 2009 Apr;9(2):154-60. doi: 10.1097/aci.0b013e3283292207.
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- Averell CM, Laliberte F, Duh MS, Wu JW, Germain G, Faison S. Characterizing Real-World Use Of Tiotropium In Asthma In The USA. J Asthma Allergy. 2019 Oct 7;12:309-321. doi: 10.2147/JAA.S216932. eCollection 2019.
- Papi A, Paggiaro PL, Nicolini G, Vignola AM, Fabbri LM; Inhaled Combination Asthma Treatment versus SYmbicort (ICAT SY) Study Group. Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma. Eur Respir J. 2007 Apr;29(4):682-9. doi: 10.1183/09031936.00095906. Epub 2006 Nov 15. Erratum In: Eur Respir J. 2007 Jun;29(6):1286. Eur Respir J. 2008 Sep;32(3):822.
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- Corradi M, Spinola M, Petruzzelli S, Kuna P. High-dose beclometasone dipropionate/formoterol fumarate in fixed-dose combination for the treatment of asthma. Ther Adv Respir Dis. 2016 Oct;10(5):492-502. doi: 10.1177/1753465816654442. Epub 2016 Jun 23.
- Kippelen P, Anderson SD, Hallstrand TS. Mechanisms and Biomarkers of Exercise-Induced Bronchoconstriction. Immunol Allergy Clin North Am. 2018 May;38(2):165-182. doi: 10.1016/j.iac.2018.01.008.
- Chau-Etchepare F, Hoerger JL, Kuhn BT, Zeki AA, Haczku A, Louie S, Kenyon NJ, Davis CE, Schivo M. Viruses and non-allergen environmental triggers in asthma. J Investig Med. 2019 Oct;67(7):1029-1041. doi: 10.1136/jim-2019-001000. Epub 2019 Jul 27.
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- Paggiaro P, Corradi M, Latorre M, Raptis H, Muraro A, Gessner C, Siergiejko Z, Scuri M, Petruzzelli S. High strength extrafine pMDI beclometasone/formoterol (200/6 mug) is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids. BMC Pulm Med. 2016 Dec 9;16(1):180. doi: 10.1186/s12890-016-0335-9.
- Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular Targets for Biological Therapies of Severe Asthma. Front Immunol. 2020 Nov 30;11:603312. doi: 10.3389/fimmu.2020.603312. eCollection 2020.
- 2022. "A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05292586.
Frequently Asked Questions
Does the trial accept elderly participants over 80 years of age?
"This trial is accepting patients from the ages of 18 to 75. There are 117 studies for minors and 193 trials designed specifically with elderly persons in mind." - Anonymous Online Contributor
Unverified Answer
Has the FDA given clearance for CHF 1535 pMDI?
"Through rigorous Phase 3 trials, our team at Power has ascertained that CHF 1535 pMDI is a safe intervention for patients. Thus, it obtained a score of 3 on the safety scale from 1 to 3." - Anonymous Online Contributor
Unverified Answer
Are the criteria necessary for enrollment in this research project met by me?
"This research trial is actively enrolling up to 580 participants, aged between 18 and 75 with a diagnosis of asthma." - Anonymous Online Contributor
Unverified Answer
How many sites are responsible for overseeing this clinical trial?
"At present, this clinical trial is recruiting from a total of 96 sites. Some of the cities in which these centres are located include Chandler, Encinitas and Huntington Beach; other locations can be found around the country. Choosing to register for participation at your closest site will help reduce travelling commitments." - Anonymous Online Contributor
Unverified Answer
Does this clinical trial presently accept new participants?
"Affirmative. Clinicaltrials.gov affirms that this experiment, which was initially posted on October 5th 2022, is currently searching for participants. In total 580 patients are needed to be recruited from 96 distinct medical sites." - Anonymous Online Contributor
Unverified Answer
What is the current enrollment number of this medical research?
"This study requires 580 eligible participants, who can conveniently enrol from Chiesi Clinical Trial Site 840895 in Chandler, Arizona or at the Chiesi Clinical Trial Site 840856 location in Encinitas, California." - Anonymous Online Contributor
Unverified Answer