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A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)

NCT03086460 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-08-16

Study results available
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Summary

To evaluate the dose-response of different doses of CHF 1531 pressurized metered dose inhaler (pMDI) containing formoterol fumarate, on lung function and other clinical outcomes and to identify the optimal dose(s) with regard to benefit/ risk ratio for further development in the target subject population.

Conditions

Interventions

DRUG

CHF 1531 pMDI

Dose Response: Test one of five different doses of CHF 1531

DRUG

Formoterol Inhalation Solution

Active Control

DRUG

Placebo pMDI

Matched Placebo

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Richard Sterling · Sterling ENT, PA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-09-08
Primary Completion
2018-07-23
Completion
2018-07-28
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 NCT03086460 on ClinicalTrials.gov