A Phase 1 interventional study of PT010 in Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by Pearl Therapeutics, Inc. (part of AstraZeneca) · Phase 1, Interventional, and Treatment
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Among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 162nd largest by enrollment of the 194 interventional ones that give a count, is one of 14 that started in 2017, is one of 42 in phase 1, and was the 206th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →14 of the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in France
Ages 18–99
AstraZeneca · Sites in India
Ages 18+
AstraZeneca · Sites in Argentina, Egypt, Mexico and 4 more countries
Ages 18+
AstraZeneca · Sites in Argentina, Colombia, Egypt and 9 more countries
Ages 30–80
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.
This study: 40 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.
284 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 44 · Phase 2 57 · Phase 3 77 · Phase 4 19
First in 1999; this study’s year is marked. 14 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 137 across the 194 interventional studies, 976 across the 89 observational. Of the 264 that completed or were terminated, 127 (48%) 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.
9 of the studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06712563AstraZenecaPooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting | 2026-12-14 |
| NCT07245576AstraZenecaAssess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis | 2027-04-30 |
| NCT07315958AstraZenecaStudy for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics | 2027-04-30 |
| NCT07073950AstraZenecaA Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation | 2027-05-31 |
| NCT07307781AstraZenecaStudy of Patient With Frequent Exacerbations in Moscow | 2027-06-25 |
Add all 9 to your calendar (.ics) → With an account.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.
Key Inclusion Criteria:
Key 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol per protocol. Administered as 2 inhalations per use as instructed in the protocol.
Drug: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.
Also known as: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) - Budesonide
Time frame: Day 1
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) - Budesonide
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) - Glycopyrronium
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) - Glycopyrronium
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) - Formoterol
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) - Formoterol
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
Time frame: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Time frame: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Time frame: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Budesonide
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Glycopyrronium
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Formoterol
Time frame: Day 1
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time to maximum plasma concentration (tmax) - Budesonide
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time to maximum plasma concentration (tmax) - Glycopyrronium
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time to maximum plasma concentration (tmax) - Formoterol
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Budesonide
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Glycopyrronium
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Formoterol
Time frame: Day 1
This study was conducted at a single center in the United States from August 2017 to December 2017.
| Milestone | PT010 |
|---|---|
| Started | 30 |
| Completed | 29 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Maximum plasma concentration (Cmax) - Budesonide
| pg/mL | PT010 |
|---|---|
| Maximum Plasma Concentration (Cmax) - Budesonide | 709.3 ± 57.2 |
Maximum plasma concentration (Cmax) - Budesonide
| pg/mL | PT010 |
|---|---|
| Maximum Plasma Concentration (Cmax) - Budesonide | 663.2 ± 65.8 |
Maximum plasma concentration (Cmax) - Glycopyrronium
| pg/mL | PT010 |
|---|---|
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | 17.2 ± 80.7 |
Maximum plasma concentration (Cmax) - Glycopyrronium
| pg/mL | PT010 |
|---|---|
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | 18.3 ± 65.4 |
Maximum plasma concentration (Cmax) - Formoterol
| pg/mL | PT010 |
|---|---|
| Maximum Plasma Concentration (Cmax) - Formoterol | 6.4 ± 48.1 |
Maximum plasma concentration (Cmax) - Formoterol
| pg/mL | PT010 |
|---|---|
| Maximum Plasma Concentration (Cmax) - Formoterol | 7.4 ± 38.1 |
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide | 2407.3 ± 45.4 |
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide | 3004.7 ± 58.5 |
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium | 42.5 ± 45.8 |
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium | 73.9 ± 52.9 |
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol | 32.6 ± 30.3 |
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol | 47.4 ± 30.0 |
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Budesonide
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide | 2731.8 ± 45.2 |
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Glycopyrronium
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium | 39.4 ± 73.5 |
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Formoterol
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol | 33.4 ± 43.4 |
Time to maximum plasma concentration (tmax) - Budesonide
| hours | PT010 |
|---|---|
| Day 1 | 0.33 (0.10 to 1.03) |
| Day 8 | 0.67 (0.10 to 2.00) |
Time to maximum plasma concentration (tmax) - Glycopyrronium
| hours | PT010 |
|---|---|
| Day 1 | 0.03 (0.03 to 4.00) |
| Day 8 | 0.10 (0.03 to 1.00) |
Time to maximum plasma concentration (tmax) - Formoterol
| hours | PT010 |
|---|---|
| Day 1 | 0.33 (0.10 to 9.97) |
| Day 8 | 0.67 (0.03 to 12.00) |
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Budesonide
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide | 2996.9 ± 41.0 |
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Glycopyrronium
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium | 61.2 ± 85.1 |
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Formoterol
| h*pg/mL | PT010 |
|---|---|
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol | 46.0 ± 33.7 |
Collected over Adverse events were collected from the time of administration of the first dose of study drug to the time of the final follow-up telephone call up to approximately 7 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PT010 | 0/30 (0%) | 0/30 (0%) | 5/30 (16.7%) |
| Event | PT010 |
|---|---|
| HeadacheNervous system disorders | 1/30 |
| Restless legs syndromeNervous system disorders | 1/30 |
| AnaemiaBlood and lymphatic system disorders | 1/30 |
| Dry mouthGastrointestinal disorders | 1/30 |
| Procedural headacheInjury, poisoning and procedural complications | 1/30 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/30 |
Safety Population: All subjects who received at least 1 dose of study drug.
| Age, Continuous(Years) | PT010 |
|---|---|
| Mean | 63.7 ± 7.5 |
| Sex: Female, Male(Participants) | PT010 |
|---|---|
| Female | 14 |
| Male | 16 |
| Ethnicity (NIH/OMB)(Participants) | PT010 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PT010 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2017 to primary completion in Dec 2017, 3 months.
Results were first posted in May 2020, 2 years 5 months after primary completion.
Of 158 industry-sponsored phase 1 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's 3 months is below that.
Counting every sponsor, half of 176 studies reached it within 4 months; a quarter within 2 and three quarters within 11.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PT010
Pulmonary Disease, Chronic Obstructive →