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About this sponsor

We are an international company based in Parma, with more than 80 years of experience and a strong focus on research, development, production and the commercialization of innovative medicines in th...


You will receive

Study related treatment at no cost

Compensation of $50 per visit (6 visits)

Study related procedures

Travel expenses covered

Medical related treatment

No insurance needed


To qualify, you must be

Male or Female

18 - 75

Years Old


This is where the study procedures will take place

Travel expenses may be reimbursed


Showing 3 of 117 available location(s)
LinQ Research

Recruiting United States, Pearland Texas

Advanced Allergy of North GA Claim this site

Recruiting United States, Gainesville Georgia

Advanced Pulmonary Sleep Research Institute of Florida Claim this site

Recruiting United States, Daytona Beach Florida

Allergy and Asthma Center Claim this site

Recruiting United States, East Providence Rhode Island

Allergy and Asthma Specialists Medical Group Claim this site

Recruiting United States, Huntington Beach California

Allergy Associates Research Center Claim this site

Recruiting United States, Portland Oregon

Allergy Asthma Diagnostic Treatment Center Claim this site

Notyetrecruiting United States, Tallahassee Florida

Allergy Asthma Medical Group and Research Center A P C Claim this site

Recruiting United States, San Diego California

Allergy Asthma Sinus Center S C Claim this site

Recruiting United States, Greenfield Wisconsin

Allianz Research Institute Inc Claim this site

Recruiting United States, Westminster California

Alpha Research Associates Claim this site

Recruiting United States, Dayton Ohio

American Health Research Inc Claim this site

Recruiting United States, Charlotte North Carolina

Amicis Clinical Trials Claim this site

Recruiting United States, Festus Missouri

Anaheim Clinical Trials LLC Claim this site

Recruiting United States, Anaheim California

Anderson Pharmaceutical Research LLC Claim this site

Recruiting United States, Anderson South Carolina

Ark Clinical Research Claim this site

Recruiting United States, Long Beach California

Arrowhead Health Centers Claim this site

Withdrawn United States, Glendale Arizona

Asthma and Allergy Associates PC and Research Center Claim this site

Recruiting United States, Colorado Springs Colorado

Avant Research Associates LLC Claim this site

Notyetrecruiting United States, Crowley Louisiana

Aventiv Research Inc Claim this site

Recruiting United States, Grove City Ohio

Aviva Research Claim this site

Recruiting United States, Escondido California

Axcess Medical Research Claim this site

Recruiting United States, Loxahatchee Florida

Axis Clinical Trials Claim this site

Recruiting United States, Los Angeles California

Bernstein Clinical Research Center LLC Claim this site

Recruiting United States, Cincinnati Ohio

BRCR Medical Center Inc Claim this site

Notyetrecruiting United States, Plantation Florida

Breathe America Claim this site

Notyetrecruiting United States, Albuquerque New Mexico

California Research Medical Group Inc Claim this site

Recruiting United States, Fullerton California

Carolina Research Partners LLC Claim this site

Notyetrecruiting United States, Rock Hill South Carolina

Cedar Crosse Research Center Claim this site

Recruiting United States, Chicago Illinois

CHEAR Center LLC Claim this site

Recruiting United States, The Bronx New York

Chesapeake Clinical Research Inc Claim this site

Recruiting United States, Baltimore Maryland

Chicago ENT Claim this site

Notyetrecruiting United States, Chicago Illinois

Chrysalis Clinical Research Claim this site

Recruiting United States, Saint George Utah

Clinical Research Associates of Tidewater Claim this site

Recruiting United States, Norfolk Virginia

Clinical Research Consortium Claim this site

Notyetrecruiting United States, Las Vegas Nevada

Clinical Research Consortium Arizona Claim this site

Notyetrecruiting United States, Tempe Arizona

Clinical Research Institute Inc Claim this site

Recruiting United States, Minneapolis Minnesota

Clinical Research of Charlotte Claim this site

Recruiting United States, Charlotte North Carolina

Clinical Research of Gastonia Claim this site

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Clinical Research of Homestead Claim this site

Recruiting United States, Miami Florida

Clinical Research of Rock Hill Claim this site

Recruiting United States, Rock Hill South Carolina

Clinical Research of the Ozarks Inc Claim this site

Recruiting United States, Rolla Missouri

Clinical Research of the Ozarks Inc Claim this site

Recruiting United States, Columbia Missouri

Clinical Research of the Ozarks Inc Claim this site

Recruiting United States, Warrensburg Missouri

Clinical Research Solutions Claim this site

Recruiting United States, Spring Hill Tennessee

Clinical Research Solutions LLC Claim this site

Recruiting United States, Smyrna Tennessee

Clinical Trial Investigators Claim this site

Recruiting United States, Tustin California

Clinical Trials Research Claim this site

Recruiting United States, Sacramento California

ClinSite LLC Claim this site

Withdrawn United States, Ann Arbor Michigan

Colorado Allergy and Asthma Centers PC Claim this site

Recruiting United States, Denver Colorado

Columbus Clinical Services LLc Claim this site

Recruiting United States, Miami Florida

CU Pharmaceutical Research Claim this site

Recruiting United States, Rock Hill South Carolina

DC Research Works Claim this site

Recruiting United States, Marietta Georgia

DelRicht Research Claim this site

Recruiting United States, New Orleans Louisiana

Downtown LA Research Center Inc Claim this site

Recruiting United States, Los Angeles California

Duluth Biomedical Research LLC Claim this site

Recruiting United States, Duluth Georgia

Easley Clinical Research Claim this site

Recruiting United States, Easley South Carolina

East Coast Institute for Research LLC Claim this site

Withdrawn United States, Jacksonville Florida

First Allergy and Clinical Research Group Inc Claim this site

Recruiting United States, Greenwood Colorado

Florida Center for Allergy and Asthma Research Claim this site

Recruiting United States, Aventura Florida

Florida Center for Allergy and Asthma Research Claim this site

Recruiting United States, Miami Florida

Florida Pulmonary Research Institute LLC Claim this site

Notyetrecruiting United States, Winter Park Florida

Greenville Pharmaceutical Research Claim this site

Recruiting United States, Greenville South Carolina

Hamilton Mill Clinical Research Claim this site

Recruiting United States, Dacula Georgia

Healthscan Clinical Trials LLC Claim this site

Recruiting United States, Montgomery Alabama

Hendersonville Pharmaceutical Research Claim this site

Recruiting United States, Hendersonville North Carolina

Henry Ford Health System Claim this site

Notyetrecruiting United States, Detroit Michigan

IMIC Inc Claim this site

Notyetrecruiting United States, Palmetto Bay Florida

International Research Partners LLC Claim this site

Notyetrecruiting United States, Doral Florida

Lake Norman Pulmonary Claim this site

Notyetrecruiting United States, Mooresville North Carolina

Lovelace Scientific Resources Inc Claim this site

Recruiting United States, Albuquerque New Mexico

Lynn Health Science Institute Claim this site

Withdrawn United States, Oklahoma City Oklahoma

Meridian Clinical Research Claim this site

Notyetrecruiting United States, Savannah Georgia

Meridien Research Claim this site

Recruiting United States, Maitland Florida

Montana Medical Research Inc Claim this site

Recruiting United States, Missoula Montana

Multi Phase Trials LLC Claim this site

Recruiting United States, San Antonio Texas

Multi Spcialty Physicians Claim this site

Recruiting United States, Surprise Arizona

NECCR Prima Care Research LLC Claim this site

Recruiting United States, Fall River Massachusetts

New Horizons Clinical Research Claim this site

Recruiting United States, Cincinnati Ohio

Northeast Medical Research Associates Inc Claim this site

Recruiting United States, South Dartmouth Massachusetts

Northern California Research Claim this site

Recruiting United States, Sacramento California

NYU Langone Pulmonary and Sleep Medicine Brooklyn Claim this site

Suspended United States, Brooklyn New York

OK Clinical Research LLC Claim this site

Recruiting United States, Edmond Oklahoma

ONCOVA Clinical Research Inc Claim this site

Recruiting United States, Saint Cloud Florida

Pecision Clinical Research LLC Claim this site

Recruiting United States, Lauderdale Lakes Florida

Penn State Hershey Medical Center Claim this site

Withdrawn United States, Hershey Pennsylvania

Pharmaceutical Research Consulting Inc Claim this site

Recruiting United States, Dallas Texas

Phoenix Clinical LLC Claim this site

Notyetrecruiting United States, Phoenix Arizona

PMG Research of Wilmington Claim this site

Withdrawn United States, Wilmington North Carolina

Princeton Center for Clinical Research Claim this site

Recruiting United States, Skillman New Jersey

Providence Clinical Research Claim this site

Recruiting United States, Toluca California

Pulmonary Disease Specialists PA d b a PDS Research Claim this site

Recruiting United States, Kissimmee Florida

Quality Clinical Research Claim this site

Recruiting United States, Omaha Nebraska

Renovatio Clinical Claim this site

Notyetrecruiting United States, The Woodlands Texas

RJE Clinical Research Claim this site

Recruiting United States, Dallas Texas

Rush University Medical Center Claim this site

Notyetrecruiting United States, Chicago Illinois

S Carolina Pharmaceutical Research LLC Claim this site

Recruiting United States, Spartanburg South Carolina

Safe Harbor Clinical Research Claim this site

Recruiting United States, East Providence Rhode Island

School of Clinical Research USA LLC Claim this site

Recruiting United States, Miami Florida

Sherman Clinical Research Claim this site

Recruiting United States, Sherman Texas

Southeastern Research Center Claim this site

Recruiting United States, Winston-Salem North Carolina

Southern California Institute For Respiratory Diseases Claim this site

Recruiting United States, Los Angeles California

Storms Clinical Research Institute Claim this site

Recruiting United States, Colorado Springs Colorado

Temple University Hospital Claim this site

Notyetrecruiting United States, Philadelphia Pennsylvania

Timber Lane Allergy Asthma Research LLC Claim this site

Recruiting United States, South Burlington Vermont

Union Pharmaceutical Research Claim this site

Recruiting United States, Union South Carolina

VitaLink Research Easley Claim this site

Recruiting United States, Easley South Carolina

VitaLink Research Gaffney Claim this site

Recruiting United States, Gaffney South Carolina

Washington University School of Medicine Claim this site

Notyetrecruiting United States, Saint Louis Missouri

Western Washington Medical Group Claim this site

Notyetrecruiting United States, Everett Washington

WR ClinSearch LLC Claim this site

Notyetrecruiting United States, Chattanooga Tennessee


Treated Condition

About This Condition


Study Details

Click each topic to learn more


Who can participate?

Ideal candidates should meet the following criteria

  • A Body Mass Index: 18.5 ≤ BMI <30 kg/m2.
  • A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhalers.
  • Subjects under stable dose of ICS (low/medium dose according to GINA guidelines 2016) for 3 months before screening visit.
  • Subjects with a positive response to a reversibility test at screening (pre - post BD), defined as ΔFEV1≥12% and ≥200mL over baseline 10-15 minutes after inhaling 4 puffs of albuterol HFA 90µg/actuation.
  • Subjects with a pre-bronchodilator FEV1 ≥ 60% and <80% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits.
  • Subjects with poorly controlled or uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire 7 © (ACQ-7) ≥1.5 (this criterion must be met at screening and at randomization visits).
  • A diagnosis of asthma as defined in the GINA Report, 2016, documented for at least 1 year prior to screening.
  • Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent form prior to initiation of any study-related procedure.
  • A basal morning (8-10 am) serum cortisol level between 7-28 µg/dL at screening (V1).

Reasons you may not be a good fit

  • Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
  • Subjects with oral candidiasis at screening or at randomization.
  • Subjects with any clinically significant, uncontrolled condition
  • Subjects who have clinically significant cardiovascular condition
  • Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement.
  • Subjects with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
  • Use of potent cytochrome P450 3A4 inhibitors within 4 weeks prior to screening.
  • History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
  • Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
  • Subjects who are mentally or legally incapacitated, or subjects accommodated in an establishment as a result of an official or judicial order.
  • Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.
  • Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-IgE, anti-IL5 or other monoclonal or polycolonal antibodies within 12 weeks prior to screening.
  • An asthma exacerbation requiring oral corticosteroids within 3 months or hospitalization within 6 months prior to screening.
  • Subjects with unresolved bacterial or viral respiratory tract, sinus or middle ear infection affecting asthma status within 2 weeks prior to screening.
  • History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
  • Current smokers or ex-smokers (tobacco and vapor cigarettes) with a smoking history of >10 pack-years or having stopped smoking one year or less prior to screening visit.
  • Inability to carry out pulmonary lung function testing, to comply with study procedures or with study drug intake.
  • Subjects who suffer from COPD as defined by the current GOLD 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as defined in GINA Report, 2016.
  • Pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control method
  • Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females at screening and randomization visits.


About This Study

Name

An 8 week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects

Status

Recruiting

ID

NCT03084718

Phase

Phase 2

Type

Interventional

Summary

An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.

Purpose

The purpose of this study is to evaluate the dose-response of different doses of CHF 781 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target patient population.

Details

This is a phase II, multicenter, randomized, double-blind, placebo and active controlled dose ranging 5-arm parallel group study to identify the optimal dose of CHF 781 pMDI with respect to lung function and other clinical efficacy and safety outcomes. After a 2 week run-in period under rescue albuterol as needed and background inhaled corticosteroid (ICS), patients will be randomized to one of the 5 study treatment groups. After randomization, patients will be assessed after 4 and 8 weeks of study treatment at the center. A follow-up phone call will be performed a week after the last visit. During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication will be recorded via subject diary. Treatment-Emergent Adverse Events (TEAEs) will be assessed and recorded throughout the study. At screening and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurements, and 12-lead ECG. Routine hematology, blood chemistry, and pregnancy testing will be performed before enrollment and at end of study. 24-hr urine cortisol and creatinine will be assessed before and after the first dose and just before the last dose of study treatment.


Study Interventions

Investigational product(s)


Beclomethasone dipropionate

Active Control

CHF 781

Dose Response: Test one of three different doses of CHF 781

Placebos

Placebo Control

What will be monitored/measured (Outcomes)

Change from baseline in pre-dose morning FEV1 at Week 8

8 Weeks


24-hr Urinary Free Cortisol and Creatinine

8 Weeks


Change from baseline in pre-dose morning FEV1 at Week 4

4 Weeks


12-lead ECG parameters (HR, QTcF, QRS, PR)

8 Weeks


Standard blood chemistry and hematology

8 Weeks


Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

8 Weeks


Change from baseline in % asthma control days

8 Weeks


Change from baseline in % asthma symptoms-free days

8 Weeks


Change from baseline in % rescue medication-free days

8 Weeks


Change from baseline in ACQ-7 score at Week 4 and 8

4Weeks & 8 Weeks


Vital signs (systolic and diastolic blood pressure)

8 Weeks


Change from baseline in pre-dose morning FVC at Week 4 and 8

4 Weeks & 8 Weeks


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