Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

Korábbi kezelés

• Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.
  • 2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.
  • 2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration.
• Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
• Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.
• Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.
• Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

Más betegség

• Current evidence of Chronic Obstructive Pulmonary Disease (COPD).
  • 5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.
  • 5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.
  • 5c. Depot corticosteroid use for any reason within 3 months of V1.
• Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
• Known history of drug or alcohol abuse within 12 months of Visit 1.
• Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

Egyéb

• Use of oral beta2-agonist within 3 months of V1.
• Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.
• Hospitalization for asthma within 2 months of Visit 1.
• Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.
• Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration.
• Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
• For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
  • Please refer to the study protocol for the complete inclusion and exclusion criteria list.

• 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
• Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
• Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
• ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
• FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
  • Participants ≥ 18 years of age: < 80%
  • Participants 12 to <18 years of age: < 90%
• FEV1 post-albuterol at V2 or V3 (if repeat needed).
  • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
  • Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
  • Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
• Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
• Demonstrate acceptable MDI/pMDI administration technique.
• Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
• eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
• No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.