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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
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Berlin
- Frankfurt am Main
- Hannover
- Leipzig
- Magdeburg
Studien-ID:
NCT04092582 2019-000795-41 GB41149
Studienzusammenfassung
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
Studien-ID
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
Einschlusskriterien
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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