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Corticosteroid
CHF 1535 pMDI for Asthma (FORCE2 Trial)
Phase 3
Waitlist Available
Led By Steven F. Weinstein, M.D.
Research Sponsored by Chiesi Farmaceutici S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
FORCE2 Trial Summary
This triallooks at how two drugs compare in helping people with asthma on high-dose steroids.
Who is the study for?
Adults aged 18-75 with stable asthma on medium or high-dose inhaled corticosteroids can join this trial. They must have a history of asthma for at least a year, onset before age 40, and meet specific lung function criteria. Women must use effective birth control if applicable.Check my eligibility
What is being tested?
The study is testing the effectiveness of CHF 1535 pMDI (a combination inhaler containing Beclomethasone Dipropionate/Formoterol Fumarate) against CHF 718 pMDI (Beclomethasone Dipropionate alone) in adults with asthma who are already using medium to high doses of inhaled corticosteroids.See study design
What are the potential side effects?
Potential side effects may include throat irritation, hoarseness, coughing, headaches, and possible increased risk of infections. Long-term use might affect bone density or cause eye issues like cataracts or glaucoma.
FORCE2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
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.
FORCE2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CHF 1535 pMDIExperimental Treatment1 Intervention
CHF 1535 pMDI 800/24µg TDD
Group II: CHF 718 pMDIActive Control1 Intervention
CHF 718 pMDI 800µg TDD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Beclomethasone dipropionate
FDA approved
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Who is running the clinical trial?
Chiesi Farmaceutici S.p.A.Lead Sponsor
200 Previous Clinical Trials
311,960 Total Patients Enrolled
69 Trials studying Asthma
229,176 Patients Enrolled for Asthma
Steven F. Weinstein, M.D.Principal InvestigatorAllergy and Asthma Specialists Medical Group and Research Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe asthma that has required hospitalization in the intensive care unit, which could put you at high risk if you participate in the study.You have had a severe asthma attack that required hospitalization, emergency room visit, or treatment with strong medication in the past 4 weeks.You have been diagnosed with asthma for at least one year and it started before you turned 40.You have been diagnosed with conditions like cystic fibrosis, bronchiectasis, COPD, or other serious lung diseases that could affect the study assessments.You are currently taking certain medications called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants.You have used alcohol or drugs excessively in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: CHF 1535 pMDI
- Group 2: CHF 718 pMDI
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Asthma Patient Testimony for trial: Trial Name: NCT05292586 — Phase 3
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