Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma

Pearl Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Asthma

Treatments: Drug: GP MDI 7.2 μg; Drug: GP MDI 28.8 μg; Drug: GP MDI 14.4 μg; Drug: Placebo MDI; Drug: Spiriva Respimat 2.5 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03358147

PT001102

Details and patient eligibility

About

Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

Full description

A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

Enrollment: 1,077 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a documented history of physician-diagnosed asthma
• Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA on a stable regimen for at least 4 weeks
• Documented reversibility to albuterol
• A pre-bronchodilator FEV1 >40% and <85% of predicted normal value for subjects 18 to 80 years of age or >40% and <90% of predicted for subjects 12 to <18 years of age
• Demonstrate acceptable spirometry performance
• Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol
• Compliance: must be willing to remain at the study center as required per protocol to complete all visit assessments

Exclusion criteria

• Oral corticosteroid use (any dose) within 4 weeks
• Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes, and marijuana)
• Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
• Completed treatment for lower respiratory infection or asthma exacerbation within 4 weeks
• Hospitalizations for asthma within 3 months
• Historical or current evidence of a clinically significant disease
• Cancer not in complete remission for at least 5 years
• Treatment with investigational study drug (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer
• Previously randomized in any PT001 study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,077 participants in 5 patient groups, including a placebo group

GP MDI 28.8 μg

Experimental group

Description:

GP MDI 14.4 μg per actuation taken as 2 inhalations BID

Treatment:

Drug: GP MDI 28.8 μg

GP MDI 14.4 μg

Experimental group

Description:

GP MDI 7.2 μg per actuation taken as 2 inhalations BID

Treatment:

Drug: GP MDI 14.4 μg

GP MDI 7.2 μg

Experimental group

Description:

GP MDI 3.6 μg per actuation taken as 2 inhalations BID

Treatment:

Drug: GP MDI 7.2 μg

Placebo MDI

Placebo Comparator group

Description:

Taken as 2 inhalations BID

Treatment:

Drug: Placebo MDI

Spiriva Respimat 2.5 μg

Other group

Description:

Open Label Spiriva Respimat 2.5 μg

Treatment:

Drug: Spiriva Respimat 2.5 μg