Clareo Health | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
