What side effects are associated with this type of intervention?

Common treatments for asthma, such as inhaled corticosteroids (ICS) like Beclomethasone Dipropionate and long-acting beta-agonists (LABA) like Formoterol Fumarate, have known side effects. ICS can cause oral thrush, hoarseness, and potential bone density reduction with long-term use. LABAs may lead to tremors, headaches, and palpitations. Combination therapies that include both ICS and LABAs may present a combination of these side effects but are generally well-tolerated when used as prescribed.

What prior FDA approvals exist?

The FDA has approved several combination therapies for asthma that include an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA). These combinations are designed to reduce inflammation and relax airway muscles, similar to CHF 1535. Notable examples include Fluticasone/Salmeterol (Advair), Budesonide/Formoterol (Symbicort), and Mometasone/Formoterol (Dulera). These treatments have been shown to improve lung function, reduce exacerbations, and enhance quality of life for asthma patients.

What other types of research exist?

Promising novel alternatives to CHF 1535 for asthma patients include: 1) Beclomethasone Dipropionate delivered via the MAGhaler, which has shown equivalent efficacy and safety to standard metered-dose inhalers. 2) Hydrofluoroalkane-134a Beclomethasone Dipropionate (HFA-BDP), which has demonstrated efficacy in improving small airway function. These alternatives offer effective options for reducing inflammation and relaxing airway muscles in asthma patients.

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Corticosteroid

Combination Inhaler vs Single Inhaler 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 up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two inhalers for asthma patients who are already on medium or high doses of inhaled corticosteroids. The goal is to see which inhaler improves breathing more effectively by reducing inflammation and relaxing airway muscles.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for asthma, such as inhaled corticosteroids and long-acting beta-agonists, work through complementary mechanisms. Inhaled corticosteroids like Beclomethasone Dipropionate reduce inflammation in the airways, which helps control chronic symptoms and prevent exacerbations. Long-acting beta-agonists such as Formoterol Fumarate relax the muscles around the airways, making it easier to breathe and providing long-term symptom control. These treatments are crucial for asthma patients as they address both the underlying inflammation and immediate bronchoconstriction, leading to better overall management of the condition.

Comparison of the effects of sequential or simultaneous administration of salbutamol and beclomethasone dipropionate.Four-week nebulized beclomethasone dipropionate in stable COPD patients with exertional dyspnoea.