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

  • Respiratory Disorder
  • Asthma
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • Bakersfield
  • Berlin
  • Białystok
  • Buenos Aires
  • Edmond
  • Frankfurt am Main
  • Hannover
  • Kraków
  • Leipzig
  • Magdeburg
  • Miami
  • Ostrowiec Świętokrzyski
  • Philadelphia
  • Poznań
  • Quilmes
  • San Isidro
  • San Miguel
  • Sosnowiec
  • Spartanburg
  • Walnut Creek
  • Winter Park
  • Wrocław
  • Łódź
Trial Identifier:

NCT04092582 2019-000795-41 GB41149

  • ALL-MED Specjalistyczna Opieka Medyczna

    95 al. Generała Józefa Hallera53-201WrocławPoland
  • Allergy & Asthma Medical Group of the Bay Area

    370 N Wiget Ln94598Walnut CreekUnited States
  • BAG Prof Dr G Hoheisel Dr A Bonitz

    04275LeipzigGermany
  • CARE - Centro de Alergia y Enfermedades Respiratorias

    Buenos AiresArgentina
  • Centro Médico Dra. Cristina de Salvo

    Buenos AiresArgentina
  • Centro Respiratorio Quilmes

    854 Av. Hipólito YrigoyenQuilmesArgentina
  • Centrum Alergologii Teresa Hofman

    16A Bogusławskiego60-238PoznańPoland
  • Centrum Medycyny Oddechowej Robert M. Mróz

    9 Piasta15-044BiałystokPoland
  • Centrum Medyczne ALL-MED

    23 Henryka Sienkiewicza30-033KrakówPoland
  • Clinica Providencia (Inverconsult Sociedad Anonima)

    250 C. Carlos Gonzales Candamo15088San MiguelPeru
  • Clinica Ricardo Palma; THORAX

    1066 Av. Javier Prado Este15036San IsidroPeru
  • Florida Ctr-Allergy & Asthma

    33173MiamiUnited States
  • Florida Pulmonary Research Institute, LLC

    32789Winter ParkUnited States
  • Fundacion Cidea

    Buenos AiresArgentina
  • IKF Pneumologie

    100-103 Schaumainkai60596Frankfurt am MainGermany
  • Kern Research

    1921 18th St93301BakersfieldUnited States
  • Malopolskie Centrum Alergologii

    40 osiedle Piastów31-625KrakówPoland
  • OK Clinical Research

    1009 N Bryant Ave73034EdmondUnited States
  • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik

    31a Iłżecka27-400Ostrowiec ŚwiętokrzyskiPoland
  • Pneumologicum

    98B Hildesheimer Str.30173HannoverGermany
  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

    68 Konstytucji41-205SosnowiecPoland
  • Research Center for Medical Studies RCMS

    10717BerlinGermany
  • SMO.MD GmbH, Zentrum für klinische Studien

    9 Bierer Weg39120MagdeburgGermany
  • Spartanburg Medical Research

    485 Simuel Rd29303SpartanburgUnited States
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    22 Dr. Stefana Kopcińskiego90-153ŁódźPoland
  • Temple University Hospital

    3401 N Broad St19140PhiladelphiaUnited States
  • Toledo Inst of Clin Research

    43617
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    This clinical trial was done to study a new medicine called, MTPS9579A, for the treatment of asthma. This study investigated whether MTPS9579A was effective for controlling asthma in people who used inhaled corticosteroids (ICS) and another medicine – a second controller for the asthma. This was a Phase 2a, multicenter, randomized, placebo-controlled, double‑blind study, conducted at 26 study centers in 5 countries.

    Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
    Phase 2a Phase
    NCT04092582, GB41149, 2019-000795-41 Trial Identifier
    MTPS9579A Treatments
    Asthma Condition
    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

    Eligibility Criteria

    All Gender
    ≥18 Years & ≤ 75 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Documented physician-diagnosed asthma for at least 12 months prior to screening
    • Treatment with asthma controller therapy (daily ICS [fluticasone propionate or equivalent] and at least one additional controller therapy [LABA, LAMA, LTM/LTRA]) for >= 3 months prior to screening, with no changes within 4 weeks prior to screening or during the screening period and no anticipated changes in controller dosing regimens throughout the study
    • Documented history of >= 2 asthma exacerbation within the 12 months prior to screening while on daily ICS maintenance therapy
    • For women of childbearing potential: agreement to remain abstinent or use contraception For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
    Exclusion Criteria
    • History or evidence of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation associated with panic attacks, or other mimics of asthma
    • History or evidence of significant respiratory disease other than asthma, including occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome, bronchiolitis, interstitial lung disease, or COPD
    • Current smoker, electronic cigarette (e-cigarette) user, former smoker with smoking history of > 10 pack-years, former e-cigarette user with an e-cigarette history of at least daily use for >=10 years, or unwilling to abstain from smoking and/or e-cigarette use from the time of consent through the completion of the study
    • History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, precludes the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study
    • Active malignancy or history of malignancy within 5 years of screening, except for appropriately treated non-melanoma skin carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or Stage I uterine cancer
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of MTPS9579A
    • Positive for TB at screening

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