A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Status: | Active, not recruiting |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/11/2019 |
Start Date: | September 20, 2016 |
End Date: | September 19, 2019 |
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Uncontrolled Severe Asthma
This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm
study will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo
as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium-
or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following
additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier
(LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The
total duration of this study for each participant is approximately 70 weeks including
screening, run-in, treatment, and follow-up.
study will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo
as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium-
or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following
additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier
(LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The
total duration of this study for each participant is approximately 70 weeks including
screening, run-in, treatment, and follow-up.
Inclusion Criteria:
- Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m^2) and weight >= 40 kg
at screening
- Documented physician-diagnosed asthma
- On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed
controller medication
- Forced expiratory volume in 1 second (FEV1) of 40% to 80% of predicted
- Evidence of uncontrolled asthma
- Use of contraceptive measures
Exclusion Criteria:
- Diagnosis of mimics of asthma
- Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma chronic obstructive
pulmonary disease overlap syndrome, or bronchiolitis, as determined by the
investigator
- Pregnant or lactating, or intending to become pregnant during the study or within 20
weeks after the last dose of MSTT1041A
- Recent history of smoking
- History or evidence of substance abuse that would pose a risk to participants safety,
interfere with the conduct of the study, have an impact on the study results
- Asthma exacerbation within 4 weeks prior to screening
- Intubation for respiratory failure due to asthma within 12 months prior to screening
- Comorbid conditions that may interfere with evaluation of investigational medicinal
product
- Known sensitivity to any of the active substances or their excipients to be
administered during dosing
- Positive pregnancy test
We found this trial at
66
sites
470 Toll Gate Road
Warwick, Rhode Island 02865
Warwick, Rhode Island 02865
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1950 Sawtelle Boulevard
Los Angeles, California 90025
Los Angeles, California 90025
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1005 Doctor DB Todd Junior Boulevard
Nashville, Tennessee 37208
Nashville, Tennessee 37208
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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