CHF 1535 pMDI for Asthma

Phase-Based Progress Estimates
Chiesi Clinical Trial Site 840823, San Antonio, TXAsthmaBeclomethasone Dipropionate/Formoterol Fumarate - Drug
18 - 75
All Sexes
What conditions do you have?

Study Summary

This triallooks at how two drugs compare in helping people with asthma on high-dose steroids.

Treatment Effectiveness

Effectiveness Progress

2 of 3
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

3 of 3
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
Experimental Group · 1 Intervention: Beclomethasone Dipropionate/Formoterol Fumarate · Intervention Types: Drug
CHF 718 pMDI
ActiveComparator Group · 1 Intervention: Beclomethasone Dipropionate · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Beclomethasone Dipropionate/Formoterol Fumarate

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?
What site did they apply to?
Chiesi Clinical Trial Site 840861100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "Really want to get my asthma under control"

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