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Trial record 3 of 5 for:    "Asthma" | Mooresville, North Carolina, U.S.

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

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ClinicalTrials.gov Identifier: NCT03358147
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: GP MDI 28.8 μg Drug: GP MDI 14.4 μg Drug: GP MDI 7.2 μg Drug: Placebo MDI Drug: Spiriva Respimat 2.5 μg Phase 2 Phase 3

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Linear repeated measures model
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind vs Placebo, Open Label Spiriva Respimat
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: GP MDI 28.8 μg
GP MDI 14.4 μg per actuation taken as 2 inhalations BID
Drug: GP MDI 28.8 μg
GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
Other Name: GP

Experimental: GP MDI 14.4 μg
GP MDI 7.2 μg per actuation taken as 2 inhalations BID
Drug: GP MDI 14.4 μg
GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
Other Name: GP

Experimental: GP MDI 7.2 μg
GP MDI 3.6 μg per actuation taken as 2 inhalations BID
Drug: GP MDI 7.2 μg
GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
Other Name: GP

Placebo Comparator: Placebo MDI
Taken as 2 inhalations BID
Drug: Placebo MDI
Placebo taken as 2 inhalations BID
Other Name: Placebo

Spiriva Respimat 2.5 μg
Open Label Spiriva Respimat 2.5 μg
Drug: Spiriva Respimat 2.5 μg
Spiriva Respimat 2.5 μg QD (open-label)
Other Name: Spiriva Respimat




Primary Outcome Measures :
  1. Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in morning pre-dose trough FEV1 [ Time Frame: Week 24 ]
  2. Time to first moderate/severe asthma exacerbation [ Time Frame: Over 24 Weeks ]
  3. Change from baseline in Asthma Control Questionnaire (ACQ)-7 [ Time Frame: Week 24 ]
    Asthma Control Questionnaire (ACQ)-7, each of the 6 questions and 1 value (FEV1 % predicted) is scored on a 7 point scale. The scale range is from 0-6. 0 is no impairment, 6 is the maximum impairment. The ACQ score is the mean of the item responses.

  4. Change from baseline in Asthma Control Questionnaire 5 (ACQ-5) [ Time Frame: Week 24 ]
    Asthma Control Questionnaire (ACQ)-5, each of the 5 questions is scored on a 7 point scale. The scale range is from 0-6. 0 is no impairment, 6 is the maximum impairment. The ACQ score is the mean of the item responses.

  5. Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) [ Time Frame: Week 24 ]
    Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12). There are 32 questions in 4 different domains (Symptoms, Activity Limitation, Emotional Function, and Environmental Stimuli). Each of the questions is scored on a 7 point scale. The scale range is from 1-7. 7 is no impairment, 1 is severe impairment. The overall score is the mean of all 32 responses, and the individual domain scores, are the mean of the items in the domains.



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358147


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
Pearl Therapeutics, Inc.

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03358147     History of Changes
Obsolete Identifiers: NCT03547466
Other Study ID Numbers: PT001102
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action