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Clinical trial

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller

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Last updated:15th Oct 2019
Identifier: NCT04092582

This is a Phase IIa, randomized, placebo-controlled, double-blind, multicenter, two-arm study to evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A as an add-on therapy in patients with uncontrolled moderate to severe asthma who are receiving daily ICS therapy and at least one of the following additional controller medications: long-acting beta-agonist (LABA), leukotriene modulator (leukotriene modifier [LTM] or leukotriene receptor antagonist [LTRA]), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Estimated Study Start Date: October 15, 2019
Estimated Primary Completion Date: February 15, 2022
Estimated Study Completion Date: February 15, 2022

Arms:
- Experimental:
MTPS9579A
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-10-08
Study type(s) Interventional
Expected enrolment 160
Study start date 2019-10-15
Estimated primary completion date 2022-02-15

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