A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid

NCT05292586 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CLI-05993AB8-02
• Study Type: interventional
• Target: 1,377
• Locations: 1 country
• Sites: 91

Brief Summary

Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.

Conditions

Asthma

Keywords

Asthma; Beclomethasone Dipropionate; Beclometasone dipropionate/Formoterol fumarate; Inhaled Corticosteroids; CHF 1535 pMDI; CHF 718 pMDI

Outcome Measures

Primary Outcomes (1)

• 1_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 12

  The pre-dose FEV1 at baseline (i.e. pre-dose on Week 0 \[Visit 2\]) and the FEV1 AUC0-12h normalised by time at Week 12 (Visit 5) are presented by treatment group in the ITT population, as change from baseline. AUC0=12h Area under the curve calculated between time 0 and 12 hours

  Baseline (pre-dose on Week 0) and Week 12.

Secondary Outcomes (12)

• 2_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at Week 12

  Baseline (pre-dose on Week 0) and Week 12.

• 3_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 0

  Baseline (pre-dose on Week 0) and Week 12.

• 4_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at Week 0

  Baseline (pre-dose on Week 0) and 3 h post dose on Week 0.

• 5_Change From Baseline in Trough FEV1 at Week 12

  Baseline (pre-dose on Week 0) and Week 12.

• 6_Change From Baseline in Pre-dose Morning FEV1 at Weeks 4, 8 and 12

  Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

Study Arms (2)

CHF 1535 pMDI

EXPERIMENTAL

CHF 1535 pMDI 800/24µg TDD

Drug: Beclomethasone Dipropionate/Formoterol Fumarate

CHF 718 pMDI

ACTIVE COMPARATOR

CHF 718 pMDI 800µg TDD

Drug: Beclomethasone Dipropionate

Interventions

Beclomethasone Dipropionate/Formoterol Fumarate DRUG

Available in pressurized inhalation solution BDP/FF 200/6 µg

Also known as: BDP/FF

CHF 1535 pMDI

Beclomethasone Dipropionate DRUG

Available in pressurized inhalation solution BDP 100 µg

Also known as: BDP

CHF 718 pMDI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
• Sex and age: Male or female aged ≥18 and ≤75 years.
• Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
• Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
• Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.
• Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 \> 12% and \> 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol hydrofluoroalkane (HFA) pMDI 90µg/actuation.
• Note for IC#5 and IC#6: In case the reversibility and/or quality threshold is not met at screening, the test can be performed once before randomization.
• Female subjects:
• a. Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
• b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).
• Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.

You may not qualify if:

• Pregnancy or lactation: where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test (serum and urine pregnancy test to be performed at screening visit and urine pregnancy test to be performed prior to randomization).
• Poor compliance with run-in medication or eDiary completion \<50% before randomization.
• History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk.
• Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
• Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening.
• Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
• Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
• Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), (as defined by the current Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
• Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit.
• E-cigarette status: Current e-cigarettes users at the time of the screening visit.
• Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
• Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
• Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate \<100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment.
• ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF \>450ms for males or QTcF \>470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation).
• Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (91)

Chiesi Clinical Trial Site 840858

Mobile, Alabama, 36608, United States

Location

Chiesi Clinical Trial Site 840895

Chandler, Arizona, 85224, United States

Location

Chiesi Clinical Trial Site 840856

Encinitas, California, 92024, United States

Location

Chiesi Clinical Trial Site 840843

Huntington Beach, California, 92647, United States

Location

Chiesi Clinical Trial Site 840860

Huntington Beach, California, 92647, United States

Location

Chiesi Clinical Trial Site 840896

Long Beach, California, 90805, United States

Location

Chiesi Clinical Trial Site 840883

Los Angeles, California, 90025, United States

Location

Chiesi Clinical Trial Site 840810

Los Angeles, California, 90048, United States

Location

Chiesi Clinical Trial Site 840869

Newport Beach, California, 92663, United States

Location

Chiesi Clinical Trial Site 840890

North Hollywood, California, 91606, United States

Location

Chiesi Clinical Trial Site 840808

Northridge, California, 91324, United States

Location

Chiesi Clinical Trial Site 840879

Pomona, California, 91768, United States

Location

Chiesi Clinical Trial Site 840868

Sacramento, California, 95823, United States

Location

Chiesi Clinical Trial Site 840849

San Diego, California, 92120, United States

Location

Chiesi Clinical Trial Site 840877

San Diego, California, 92123, United States

Location

Chiesi Clinical Trial Site 840861

San Jose, California, 95117, United States

Location

Chiesi Clinical Trial Site 840881

Westminster, California, 92683, United States

Location

Chiesi Clinical Trial Site 840873

Colorado Springs, Colorado, 80907, United States

Location

Chiesi Clinical Trial Site 840800

Denver, Colorado, 80230, United States

Location

Chiesi Clinical Trial Site 840820

Coral Gables, Florida, 33134, United States

Location

Chiesi Clinical Trial Site 840841

Cutler Bay, Florida, 33189, United States

Location

Chiesi Clinical Trial Site 840817

Greenacres City, Florida, 33467, United States

Location

Chiesi Clinical Trial Site 840822

Hialeah, Florida, 33012, United States

Location

Chiesi Clinical Trial Site 840838

Hialeah, Florida, 33015, United States

Location

Chiesi Clinical Trial Site 840864

Kissimmee, Florida, 34746, United States

Location

Chiesi Clinical Trial Site 840814

Miami, Florida, 33125, United States

Location

Chiesi Clinical Trial Site 840819

Miami, Florida, 33126, United States

Location

Chiesi Clinical Trial Site 840875

Miami, Florida, 33126, United States

Location

Chiesi Clinical Trial Site 840887

Miami, Florida, 33134, United States

Location

Chiesi Clinical Trial Site 840821

Miami, Florida, 33136, United States

Location

Chiesi Clinical Trial Site 840829

Miami, Florida, 33155, United States

Location

Chiesi Clinical Trial Site 840828

Miami, Florida, 33165, United States

Location

Chiesi Clinical Trial Site 840847

Miami, Florida, 33172, United States

Location

Chiesi Clinical Trial Site 840818

Miami, Florida, 33174, United States

Location

Chiesi Clinical Trial Site 840802

Miami, Florida, 33176, United States

Location

Chiesi Clinical Trial Site 840835

Miami, Florida, 33184, United States

Location

Chiesi Clinical Trial Site 840806

Miami, Florida, 33185, United States

Location

Chiesi Clinical Trial Site 840855

Miami, Florida, 33186, United States

Location

Chiesi Clinical Trial Site 840809

Miami Gardens, Florida, 33014, United States

Location

Chiesi Clinical Trial Site 840863

Miami Lakes, Florida, 33014, United States

Location

Chiesi Clinical Trial Site 840865

Miami Lakes, Florida, 33014, United States

Location

Chiesi Clinical Trial Site 840831

Miami Springs, Florida, 33166, United States

Location

Chiesi Clinical Trial Site 840839

Palmetto Bay, Florida, 33157, United States

Location

Chiesi Clinical Trial Site 840840

Pembroke Pines, Florida, 33024, United States

Location

Chiesi Clinical Trial Site 840827

Pembroke Pines, Florida, 33029, United States

Location

Chiesi Clinical Trial Site 840811

Port Saint Lucie, Florida, 34952, United States

Location

Chiesi Clinical Trial Site 840889

St. Petersburg, Florida, 33707, United States

Location

Chiesi Clinical Trial Site 840834

St. Petersburg, Florida, 33709, United States

Location

Chiesi Clinical Trial Site 840880

St. Petersburg, Florida, 33713, United States

Location

Chiesi Clinical Trial Site 840807

Tallahassee, Florida, 32308, United States

Location

Chiesi Clinical Trial Site 840871

Adairsville, Georgia, 30103, United States

Location

Chiesi Clinical Trial Site 840824

White Marsh, Maryland, 21162, United States

Location

Chiesi Clinical Trial Site 840826

North Dartmouth, Massachusetts, 02747, United States

Location

Chiesi Clinical Trial Site 840859

Columbia, Missouri, 65203, United States

Location

Chiesi Clinical Trial Site 840888

Saint Charles, Missouri, 63301, United States

Location

Chiesi Clinical Trial Site 840846

St Louis, Missouri, 63141, United States

Location

Chiesi Clinical Trial Site 840867

Bellevue, Nebraska, 68123, United States

Location

Chiesi Clinical Trial Site 840897

Henderson, Nevada, 89052, United States

Location

Chiesi Clinical Trial Site 840872

North Las Vegas, Nevada, 89030, United States

Location

Chiesi Clinical Trial Site 840836

Brick, New Jersey, 08724, United States

Location

Chiesi Clinical Trial Site 840851

Albuquerque, New Mexico, 87108, United States

Location

Chiesi Clinical Trial Site 840899

Monroe, North Carolina, 28112, United States

Location

Chiesi Clinical Trial Site 840852

Raleigh, North Carolina, 27607, United States

Location

Chiesi Clinical Trial Site 840866

Edmond, Oklahoma, 73034, United States

Location

Chiesi Clinical Trial Site 840878

Tulsa, Oklahoma, 74133, United States

Location

Chiesi Clinical Trial Site 840884

Grants Pass, Oregon, 97527, United States

Location

Chiesi Clinical Trial Site 840830

Medford, Oregon, 97504, United States

Location

Chiesi Clinical Trial Site 840853

Portland, Oregon, 97202, United States

Location

Chiesi Clinical Trial Site 840885

Warwick, Rhode Island, 02886, United States

Location

Chiesi Clinical Trial Site 840892

Anderson, South Carolina, 29621, United States

Location

Chiesi Clinical Trial Site 840844

Columbia, South Carolina, 29204, United States

Location

Chiesi Clinical Trial Site 840850

Greenville, South Carolina, 29615, United States

Location

Chiesi Clinical Trial Site 840894

Rock Hill, South Carolina, 29732, United States

Location

Chiesi Clinical Trial Site 840891

Spartanburg, South Carolina, 29303, United States

Location

Chiesi Clinical Trial Site 840812

Knoxville, Tennessee, 37909, United States

Location

Chiesi Clinical Trial Site 840815

Baytown, Texas, 77521, United States

Location

Chiesi Clinical Trial Site 840874

Boerne, Texas, 78006, United States

Location

Chiesi Clinical Trial Site 840845

Carrollton, Texas, 75007, United States

Location

Chiesi Clinical Trial Site 840876

Dallas, Texas, 75225, United States

Location

Chiesi Clinical Trial Site 840803

El Paso, Texas, 79903, United States

Location

Chiesi Clinical Trial Site 840833

Houston, Texas, 77094, United States

Location

Chiesi Clinical Trial Site 840862

McKinney, Texas, 75069, United States

Location

Chiesi Clinical Trial Site 840816

McKinney, Texas, 75071, United States

Location

Chiesi Clinical Trial Site 840842

San Antonio, Texas, 78207, United States

Location

Chiesi Clinical Trial Site 840857

San Antonio, Texas, 78215, United States

Location

Chiesi Clinical Trial Site 840823

San Antonio, Texas, 78258, United States

Location

Chiesi Clinical Trial Site 840801

Sugar Land, Texas, 77479, United States

Location

Chiesi Clinical Trial Site 840893

Murray, Utah, 84107, United States

Location

Chiesi Clinical Trial Site 840837

Riverton, Utah, 84065, United States

Location

Chiesi Clinical Trial Site 840882

Bellingham, Washington, 98225, United States

Location

Chiesi Clinical Trial Site 840870

Greenfield, Wisconsin, 53228, United States

Location

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MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Study Officials

• Steven F. Weinstein, M.D.

  Allergy and Asthma Specialists Medical Group and Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinded roles were participant, investigator, care provider, monitor, data analyst, and assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 23, 2022
• Study Start: August 31, 2022
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (91)