Select Your Region
Americas
Europa
Afrika
Weltweit
Teilnehmende, medizinische Einrichtungen finden und deren aktuellen Studienstatus anzeigen
Teilnehmende, medizinische Einrichtungen finden
-
Startseite
-
Suche nach klinischen Studien
- Details zu klinischen Studien
Eine Studie zur Beurteilung der Wirksamkeit, Sicherheit und Pharmakokinetik von MTPS9579A bei Patient*innen mit Asthma, die inhalative Kortikosteroide und eine zweite Kontrollmedikation benötigen
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Atemwegserkrankungen Asthma
Basisinformationen
Sponsor
Genentech, Inc.
Phase
Phase 2
Studien-ID
NCT04092582, GB41149, 2019-000795-41
Condition
Asthma
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
Einschlusskriterien
All
≥18 Years & ≤ 75 Years
No
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
Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.
Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.
Results Disclaimer
Entdecken Sie ähnliche Studien
Studienergebnisse
LPS GB41149 Final Results April 2023 German
(PDF, 0.2 MB)
Entdecken Sie ähnliche Studien
Um die aktuellste Version dieser Seite aufzurufen gehen Sie bitte auf www.Klinische-studien-für-patienten.de
Teilen Sie Informationen über diese klinische Studie
Link to Pagedurch eine der folgenden Optionen
In die Zwischenablage kopiert