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

NCT03084718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2021-12-14

Study results available
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Summary

The purpose of this study is to evaluate the dose-response of different doses of CHF 781 Pressurized Metered Dose Inhaler (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.

Conditions

Interventions

DRUG

CHF 718 pMDI

Dose Response: Test one of three different doses of CHF 718 pMDI

DRUG

Placebo pMDI

Placebo Control

DRUG

Beclomethasone Dipropionate (BDP)

Active Control

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • David Bernstein, MD · Bernstein Clinical Research Center, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2018-11-28
Completion
2018-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084718 on ClinicalTrials.gov