A Phase 2/3 interventional study of GP MDI 28.8 μg and GP MDI 14.4 μg in Asthma, sponsored by Pearl Therapeutics, Inc.. Completed at 232 sites in United States. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Pearl Therapeutics, Inc. (part of AstraZeneca) · Phase 2/3, Interventional, and Treatment
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Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.
Among the 359 studies in Asthma by AstraZeneca, this one is the 28th largest by enrollment of the 248 interventional ones that give a count, is one of 13 that started in 2017, is one of 2 in phase 2/3, and was the 229th registered.
4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.
Browse Asthma studies →19 of the 359 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in China
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
AstraZeneca · Sites in China
Ages 18–75
AstraZeneca · Sites in United States, Argentina, Czechia and 4 more countries
Ages 4–11
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 12 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
359 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 52 · Phase 3 123 · Phase 4 23
First in 1996; this study’s year is marked. 13 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,077 is above the median of 79 across 3,342 interventional studies indexed under Asthma.
Median enrollment 175 across the 248 interventional studies, 500 across the 110 observational. Of the 330 that completed or were terminated, 129 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Pearl Therapeutics, Inc., one of the names counted as AstraZeneca. Under that name alone:
Pearl Therapeutics, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.
13 of the studies in Asthma by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT06471257Phase 3AstraZenecaA Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma | 2027-10-04 |
| NCT06307665Phase 3AstraZenecaEvaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | 2027-10-13 |
| NCT07218172AstraZenecaCharacterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B) | 2026-11-30 |
Add all 13 to your calendar (.ics) → With an account.
Among the 359 studies in Asthma by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GP MDI 14.4 μg per actuation taken as 2 inhalations BID
Drug: GP MDI 28.8 μg
GP MDI 7.2 μg per actuation taken as 2 inhalations BID
Drug: GP MDI 14.4 μg
GP MDI 3.6 μg per actuation taken as 2 inhalations BID
Drug: GP MDI 7.2 μg
Taken as 2 inhalations BID
Drug: Placebo MDI
Open Label Spiriva Respimat 2.5 μg
Drug: Spiriva Respimat 2.5 μg
GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
Also known as: GP
GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
Also known as: GP
GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
Also known as: GP
Placebo taken as 2 inhalations BID
Also known as: Placebo
Spiriva Respimat 2.5 μg QD (open-label)
Also known as: Spiriva Respimat
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4)
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).
Time frame: Week 24
Change From Baseline in Morning Pre-dose Trough FEV1
Time frame: Week 24
Rate of Moderate to Severe Asthma Exacerbations
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)
Time frame: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Change From Baseline in ACQ-7 (Asthma Control Questionnaire)
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.
Time frame: Week 24
Change From Baseline in ACQ-5 (Asthma Control Questionnaire)
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).
Time frame: Week 24
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12)
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.
Time frame: Week 24
The study randomized subjects at 194 sites in the United States from December 2017 to September 2019. The entire study period was scheduled to take up to approximately 26 weeks for each individual subject from the time of screening through the follow up period.
| Milestone | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Started | 235 | 240 | 240 | 237 | 119 |
| Completed | 201 | 201 | 206 | 201 | 105 |
| Not completed | 34 | 39 | 34 | 36 | 14 |
| Withdrew: Withdrawal by subject | 13 | 19 | 16 | 10 | 5 |
| Withdrew: Adverse event | 3 | 9 | 7 | 5 | 2 |
| Withdrew: Lost to follow-up | 4 | 3 | 7 | 6 | 4 |
| Withdrew: Major protocol deviation | 11 | 3 | 2 | 3 | 1 |
| Withdrew: Protocol specified criteria | 2 | 3 | 0 | 3 | 1 |
| Withdrew: Physician decision | 1 | 0 | 1 | 6 | 1 |
| Withdrew: Administrative reasons | 0 | 1 | 0 | 3 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 1 | 0 | 0 |
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).
| Liter | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4) | 0.294 (0.248 to 0.341) | 0.284 (0.238 to 0.331) | 0.308 (0.263 to 0.354) | 0.240 (0.194 to 0.287) | 0.347 (0.282 to 0.412) |
| Liter | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 | 0.142 (0.097 to 0.188) | 0.108 (0.063 to 0.153) | 0.142 (0.098 to 0.187) | 0.129 (0.084 to 0.174) | 0.150 (0.087 to 0.213) |
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)
| Events per year | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Rate of Moderate to Severe Asthma Exacerbations | 0.43 ± 0.078 | 0.44 ± 0.080 | 0.41 ± 0.076 | 0.55 ± 0.092 | 0.50 ± 0.123 |
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.
| Scores on a scale | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Change From Baseline in ACQ-7 (Asthma Control Questionnaire) | -0.78 (-0.89 to -0.66) | -0.73 (-0.84 to -0.62) | -0.90 (-1.01 to -0.79) | -0.80 (-0.91 to -0.69) | -0.90 (-1.06 to -0.74) |
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).
| Scores on a scale | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Change From Baseline in ACQ-5 (Asthma Control Questionnaire) | -0.87 (-1.00 to -0.73) | -0.80 (-0.93 to -0.67) | -1.02 (-1.15 to -0.89) | -0.93 (-1.06 to -0.80) | -1.03 (-1.22 to -0.85) |
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.
| Scores on a scale | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) | 0.89 (0.74 to 1.04) | 0.90 (0.75 to 1.04) | 1.02 (0.87 to 1.16) | 0.96 (0.82 to 1.11) | 1.04 (0.84 to 1.25) |
Collected over Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call up to approximately 30 weeks. Adverse Events were collected from the time subject was randomized up to approximately 26 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GP MDI 28.8 μg | 0/235 (0%) | 9/235 (3.8%) | 33/235 (14%) |
| GP MDI 14.4 μg | 0/240 (0%) | 7/240 (2.9%) | 35/240 (14.6%) |
| GP MDI 7.2 μg | 0/240 (0%) | 6/240 (2.5%) | 33/240 (13.8%) |
| Placebo MDI | 0/237 (0%) | 7/237 (3%) | 29/237 (12.2%) |
| Spiriva Respimat 2.5 μg | 0/119 (0%) | 2/119 (1.7%) | 14/119 (11.8%) |
| Event | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 2/235 | 0/240 | 1/240 | 0/237 | 0/119 |
| InfluenzaInfections and infestations | 0/235 | 0/240 | 0/240 | 1/237 | 1/119 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/235 | 0/240 | 2/240 | 1/237 | 1/119 |
| Klebsiella bacteraemiaInfections and infestations | 1/235 | 0/240 | 0/240 | 0/237 | 0/119 |
| SepsisInfections and infestations | 1/235 | 0/240 | 0/240 | 0/237 | 0/119 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/235 | 0/240 | 0/240 | 0/237 | 0/119 |
| Acute kidney injuryRenal and urinary disorders | 1/235 | 0/240 | 0/240 | 0/237 | 0/119 |
| CholecystitisHepatobiliary disorders | 1/235 | 0/240 | 0/240 | 0/237 | 0/119 |
| Miscarriage of partnerSocial circumstances | 1/235 | 0/240 | 0/240 | 0/237 | 0/119 |
| Abdominal painGastrointestinal disorders | 1/235 | 0/240 | 0/240 | 0/237 | 0/119 |
| Event | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 14/235 | 14/240 | 14/240 | 19/237 | 6/119 |
| NasopharyngitisInfections and infestations | 11/235 | 15/240 | 17/240 | 8/237 | 2/119 |
| SinusitisInfections and infestations | 10/235 | 7/240 | 4/240 | 3/237 | 7/119 |
| Age, Continuous(Years) | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg | Total |
|---|---|---|---|---|---|---|
| Mean | 48.4 ± 15.1 | 47.7 ± 16.8 | 46.7 ± 15.5 | 47.1 ± 16.2 | 49.8 ± 15.3 | 47.7 ± 15.8 |
| Sex: Female, Male(Participants) | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg | Total |
|---|---|---|---|---|---|---|
| Female | 146 | 153 | 151 | 134 | 76 | 660 |
| Male | 89 | 87 | 89 | 103 | 43 | 411 |
| Ethnicity (NIH/OMB)(Participants) | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 36 | 61 | 52 | 51 | 21 | 221 |
| Not Hispanic or Latino | 198 | 179 | 186 | 186 | 98 | 847 |
| Unknown or Not Reported | 1 | 0 | 2 | 0 | 0 | 3 |
| Race (NIH/OMB)(Participants) | GP MDI 28.8 μg | GP MDI 14.4 μg | GP MDI 7.2 μg | Placebo MDI | Spiriva Respimat 2.5 μg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 3 | 0 | 1 | 5 |
| Asian | 6 | 1 | 6 | 2 | 0 | 15 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 0 | 1 |
| Black or African American | 62 | 68 | 52 | 52 | 25 | 259 |
| White | 165 | 168 | 177 | 179 | 93 | 782 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 2 | 4 | 0 | 9 |
Showing the first 100 of 232 sites. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Sep 2019, 20 months.
Results were first posted in Aug 2020, 11 months after primary completion.
Of 14 phase 2/3 interventional studies under Asthma, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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