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

August 11, 2020 updated by: Pearl Therapeutics, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1077

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Birmingham, Alabama, United States, 35243
        • Research Site
      • Dothan, Alabama, United States, 36303
        • Research Site
      • Guntersville, Alabama, United States, 35976
        • Research Site
      • Jasper, Alabama, United States, 35501
        • Research Site
      • Scottsboro, Alabama, United States, 35768
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Flagstaff, Arizona, United States, 86001
        • Research Site
      • Phoenix, Arizona, United States, 85018
        • Research Site
      • Tempe, Arizona, United States, 85283
        • Research Site
      • Tucson, Arizona, United States, 85745
        • Research Site
      • Tucson, Arizona, United States, 85710
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Research Site
      • Little Rock, Arkansas, United States, 72205
        • Research Site
      • Little Rock, Arkansas, United States, 72212
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Bakersfield, California, United States, 93301
        • Research Site
      • Corona, California, United States, 92879
        • Research Site
      • Costa Mesa, California, United States, 92627
        • Research Site
      • El Cajon, California, United States, 92020
        • Research Site
      • Encinitas, California, United States, 92024
        • Research Site
      • Fresno, California, United States, 93702
        • Research Site
      • Fullerton, California, United States, 92835
        • Research Site
      • Gold River, California, United States, 95670
        • Research Site
      • Huntington Beach, California, United States, 92647
        • Research Site
      • Long Beach, California, United States, 90806
        • Research Site
      • Long Beach, California, United States, 90036
        • Research Site
      • Los Angeles, California, United States, 90017
        • Research Site
      • Los Angeles, California, United States, 90048
        • Research Site
      • Mission Viejo, California, United States, 92691
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • North Hollywood, California, United States, 91606
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • Palmdale, California, United States, 93551
        • Research Site
      • Poway, California, United States, 92064
        • Research Site
      • Quartz Hill, California, United States, 93536
        • Research Site
      • Rancho Mirage, California, United States, 92270
        • Research Site
      • Riverside, California, United States, 92506
        • Research Site
      • Rolling Hills Estates, California, United States, 90274
        • Research Site
      • Sacramento, California, United States, 95821
        • Research Site
      • Sacramento, California, United States, 95823
        • Research Site
      • Sacramento, California, United States, 95831
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
      • San Diego, California, United States, 92123
        • Research Site
      • San Diego, California, United States, 92117
        • Research Site
      • San Diego, California, United States, 92119
        • Research Site
      • San Jose, California, United States, 95117
        • Research Site
      • Stockton, California, United States, 95207
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
      • Westminster, California, United States, 92683
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    • Colorado
      • Centennial, Colorado, United States, 80112
        • Research Site
      • Colorado Springs, Colorado, United States, 80907
        • Research Site
      • Colorado Springs, Colorado, United States, 80910
        • Research Site
      • Lafayette, Colorado, United States, 80026
        • Research Site
      • Wheat Ridge, Colorado, United States, 80033
        • Research Site
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Research Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Research Site
      • Brandon, Florida, United States, 33511
        • Research Site
      • Clearwater, Florida, United States, 33765
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Gainesville, Florida, United States, 32653
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Hialeah, Florida, United States, 33013
        • Research Site
      • Hialeah, Florida, United States, 33016
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Lake City, Florida, United States, 32055
        • Research Site
      • Loxahatchee Groves, Florida, United States, 33470
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33186
        • Research Site
      • Miami, Florida, United States, 33176
        • Research Site
      • Miami, Florida, United States, 33175
        • Research Site
      • Miami, Florida, United States, 33174
        • Research Site
      • Ocala, Florida, United States, 34471
        • Research Site
      • Ocoee, Florida, United States, 34761
        • Research Site
      • Orlando, Florida, United States, 32811
        • Research Site
      • Panama City, Florida, United States, 32405
        • Research Site
      • Pembroke Pines, Florida, United States, 33029
        • Research Site
      • Saint Cloud, Florida, United States, 34769
        • Research Site
      • Tallahassee, Florida, United States, 32308
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
      • Winter Park, Florida, United States, 32789
        • Research Site
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Research Site
      • Albany, Georgia, United States, 31707
        • Research Site
      • Atlanta, Georgia, United States, 30345
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Research Site
      • Dacula, Georgia, United States, 30019
        • Research Site
      • Gainesville, Georgia, United States, 30501
        • Research Site
      • Lawrenceville, Georgia, United States, 30046
        • Research Site
      • Norcross, Georgia, United States, 30071
        • Research Site
      • Rincon, Georgia, United States, 31326
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
      • Stockbridge, Georgia, United States, 30281
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Research Site
      • Meridian, Idaho, United States, 83646
        • Research Site
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Research Site
      • O'Fallon, Illinois, United States, 62269
        • Research Site
      • River Forest, Illinois, United States, 60305
        • Research Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Research Site
      • Michigan City, Indiana, United States, 46360
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, United States, 41017
        • Research Site
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Research Site
      • Shreveport, Louisiana, United States, 71106
        • Research Site
      • Zachary, Louisiana, United States, 70791
        • Research Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Research Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
      • White Marsh, Maryland, United States, 21162
        • Research Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Research Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Research Site
      • Farmington Hills, Michigan, United States, 48336
        • Research Site
      • Rochester, Michigan, United States, 48307
        • Research Site
      • Troy, Michigan, United States, 48085
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Research Site
      • Fridley, Minnesota, United States, 55432
        • Research Site
      • Minneapolis, Minnesota, United States, 55402
        • Research Site
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
      • Woodbury, Minnesota, United States, 55125
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Research Site
      • Columbia, Missouri, United States, 65203
        • Research Site
      • Saint Charles, Missouri, United States, 63301
        • Research Site
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Research Site
      • Bellevue, Nebraska, United States, 68123
        • Research Site
      • Lincoln, Nebraska, United States, 68505
        • Research Site
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Site
      • Las Vegas, Nevada, United States, 89106
        • Research Site
      • Las Vegas, Nevada, United States, 89146
        • Research Site
      • Reno, Nevada, United States, 89503
        • Research Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Research Site
      • Ocean City, New Jersey, United States, 07712
        • Research Site
      • Skillman, New Jersey, United States, 08558
        • Research Site
      • Toms River, New Jersey, United States, 08755
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Research Site
      • Albuquerque, New Mexico, United States, 87109
        • Research Site
    • New York
      • Bronx, New York, United States, 10455
        • Research Site
      • Bronx, New York, United States, 10468
        • Research Site
      • Cortland, New York, United States, 13045
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
      • Watertown, New York, United States, 13601
        • Research Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Research Site
      • Charlotte, North Carolina, United States, 28277
        • Research Site
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Elizabeth City, North Carolina, United States, 27909
        • Research Site
      • Gastonia, North Carolina, United States, 28054
        • Research Site
      • Greensboro, North Carolina, United States, 27408
        • Research Site
      • Hickory, North Carolina, United States, 28078
        • Research Site
      • Huntersville, North Carolina, United States, 28078
        • Research Site
      • Monroe, North Carolina, United States, 28112
        • Research Site
      • Mooresville, North Carolina, United States, 28117
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Research Site
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Research Site
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Columbus, Ohio, United States, 43207
        • Research Site
      • Dayton, Ohio, United States, 45459
        • Research Site
      • Dayton, Ohio, United States, 45419
        • Research Site
      • Dublin, Ohio, United States, 43016
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
      • Wooster, Ohio, United States, 44691
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73131
        • Research Site
      • Tulsa, Oklahoma, United States, 74136
        • Research Site
    • Oregon
      • Clackamas, Oregon, United States, 97015-5737
        • Research Site
      • Medford, Oregon, United States, 97504
        • Research Site
      • Portland, Oregon, United States, 97202
        • Research Site
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15665
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15236
        • Research Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Research Site
      • Warwick, Rhode Island, United States, 02886
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Charleston, South Carolina, United States, 29406
        • Research Site
      • Gaffney, South Carolina, United States, 29340
        • Research Site
      • Gaffney, South Carolina, United States, 29341
        • Research Site
      • Greenville, South Carolina, United States, 29615
        • Research Site
      • Hodges, South Carolina, United States, 29653
        • Research Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
      • Myrtle Beach, South Carolina, United States, 29588
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
      • Spartanburg, South Carolina, United States, 29301
        • Research Site
      • Union, South Carolina, United States, 29379
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Research Site
      • Hendersonville, Tennessee, United States, 37075
        • Research Site
      • Johnson City, Tennessee, United States, 37601
        • Research Site
      • Smyrna, Tennessee, United States, 37167
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Austin, Texas, United States, 78759
        • Research Site
      • Boerne, Texas, United States, 78006
        • Research Site
      • Carrollton, Texas, United States, 75007
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Dallas, Texas, United States, 75235
        • Research Site
      • El Paso, Texas, United States, 79903
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77058
        • Research Site
      • Houston, Texas, United States, 77099
        • Research Site
      • Kerrville, Texas, United States, 78028
        • Research Site
      • Killeen, Texas, United States, 76542
        • Research Site
      • Lampasas, Texas, United States, 76550
        • Research Site
      • Live Oak, Texas, United States, 78233
        • Research Site
      • Lufkin, Texas, United States, 75904
        • Research Site
      • Pearland, Texas, United States, 77584
        • Research Site
      • Plano, Texas, United States, 75093
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78215
        • Research Site
      • San Antonio, Texas, United States, 78205
        • Research Site
      • San Antonio, Texas, United States, 78258
        • Research Site
      • Sherman, Texas, United States, 75092
        • Research Site
      • Tomball, Texas, United States, 77375
        • Research Site
      • Waco, Texas, United States, 76712
        • Research Site
    • Utah
      • Murray, Utah, United States, 84107
        • Research Site
      • Salt Lake City, Utah, United States, 84107
        • Research Site
      • Salt Lake City, Utah, United States, 84102
        • Research Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Research Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Research Site
      • Newport News, Virginia, United States, 23606
        • Research Site
      • Richmond, Virginia, United States, 23226
        • Research Site
      • Richmond, Virginia, United States, 23114
        • Research Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • Research Site
      • Spokane Valley, Washington, United States, 99216
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Research Site
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • GP
PLACEBO_COMPARATOR: Placebo MDI
Taken as 2 inhalations BID
Drug: Placebo MDI
Placebo taken as 2 inhalations BID
Other Names:
  • Placebo
OTHER: 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 Names:
  • Spiriva Respimat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4)AUC was normalized for length of follow up (e.g. typically 4 hours).
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Morning Pre-dose Trough FEV1
Time Frame: Week 24
Week 24
Rate of Moderate to Severe Asthma Exacerbations
Time Frame: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Rate of moderate to severe Asthma exacerbations (A deterioration of asthma requiring a new or increased dose of ICS for at least 3 days) or severe Asthma exacerbation (Use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days OR a hospitalization or ER visit because of asthma)
over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Change From Baseline in ACQ-7 (Asthma Control Questionnaire)
Time Frame: Week 24
ACQ-7: The ACQ, comprising 7 questions, is completed in the clinic and requires subjects to recall their experiences during the previous week (7 days) prior to the study visit. The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze); the ACQ-6 is these symptom measurements plus daily rescue medication use as recalled by the subject; and the ACQ 7 is the ACQ 6 plus airway caliber as measured by pre-bronchodilator FEV1 percent predicted. Each question is scored on a 7-point scale (generally, 0=no impairment, 6=maximum impairment), the questions are equally weighted, and the ACQ score is the mean of the item responses and therefore ranges from 0 (totally controlled) to 6 (severely uncontrolled.
Week 24
Change From Baseline in ACQ-5 (Asthma Control Questionnaire)
Time Frame: Week 24
ACQ-5:The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). Each question is scored on a 7-point scale (generally, 0=no impairment, 6=maximum impairment), the questions are equally weighted, and the ACQ score is the mean of the item responses and therefore ranges from 0 (totally controlled) to 6 (severely uncontrolled).
Week 24
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12)
Time Frame: Week 24
AQLQ +12 - Asthma Quality of Life Questionnaire The AQLQ +12 is a 32-item validated subject-administered questionnaire that was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (≥18 years of age) and adolescents (12 to 17 years of age) with asthma. The 32 questions in the AQLQ +12 are in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). All 4 domains contain standard specific questions relating to each domain. Subjects are asked to think about how they have been during the previous 2 weeks. Responses to each of the 32 questions are on a 7-point scale (7=no impairment to 1=severe impairment). The overall AQLQ +12 score is the mean of all 32 responses. Overall scores range from 1=severe impairment to 7=no impairment.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pearl Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PT001102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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