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Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients

NCT03944707 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-10-11

Study results available
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Summary

This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064 100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of budesonide 80 µg/formoterol 4.5 µg two inhalations twice a day (b.i.d).

Conditions

Interventions

DRUG

LOU064 100 mg

LOU064 100 mg once daily orally administered as two 50 mg capsules

DRUG

Placebo

Placebo once daily administered orally as capsules

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2020-04-27
Completion
2020-04-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Germany
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03944707 on ClinicalTrials.gov