A Phase 1 interventional study of PT010 (BGF MDI) 320/14.4/9.6 µg and PT010 (BGF MDI) 160/14.4/9.6 µg in Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics, Inc.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.
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 116th 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 200th 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: 18 Years to 45 Years · all sexes · healthy volunteers too.
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 96 is above 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.
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects
A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days
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.
A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception
-Be in good general health as assessed at Screening and have no abnormal labs at Screening.
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.
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.
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.
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 recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
Drug: PT010 (BGF MDI) 320/14.4/9.6 µg
PT010 (BGF MDI) 160/14.4/9.6 µg
Drug: PT010 (BGF MDI) 160/14.4/9.6 µg
PT003 (GFF MDI) 14.4/9.6 µg
Drug: PT003 (GFF MDI) 14.4/9.6 µg
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Also known as: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Also known as: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Also known as: Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) of Budesonide Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) of Budesonide Day 8
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) of Glycopyrronium Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) of Glycopyrronium Day 8
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) of Formoterol Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) of Formoterol Day 8
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8
Time frame: Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8
Time frame: Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
Time frame: Day 8
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time to maximum plasma concentration (tmax) - Budesonide Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time to maximum plasma concentration (tmax) - Budesonide Day 8
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time to maximum plasma concentration (tmax) - Formoterol Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time to maximum plasma concentration (tmax) - Formoterol Day 8
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
Time frame: Day 1
Elimination Half-life (t½) - Budesonide
Elimination half-life (t½) - Budesonide Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination Half-life (t½) - Glycopyrronium
Elimination half-life (t½) - Glycopyrronium Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination Half-life (t½) - Formoterol
Elimination half-life (t½) - Formoterol Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Total Body Clearance (CL/F) - Budesonide
Apparent total body clearance (CL/F) - Budesonide Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Total Body Clearance (CL/F) - Glycopyrronium
Apparent total body clearance (CL/F) - Glycopyrronium Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Total Body Clearance (CL/F) - Formoterol
Apparent total body clearance (CL/F) - Formoterol Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Volume of Distribution (Vd/F) - Budesonide
Apparent volume of distribution (Vd/F) - Budesonide - Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Volume of Distribution (Vd/F) - Glycopyrronium
Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Volume of Distribution (Vd/F) - Formoterol
Apparent volume of distribution (Vd/F) - Formoterol - Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal Elimination Rate Constant (λz) - Budesonide
Terminal elimination rate constant (λz) - Budesonide - Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal Elimination Rate Constant (λz) - Glycopyrronium
Terminal elimination rate constant (λz) - Glycopyrronium - Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal Elimination Rate Constant (λz) - Formoterol
Terminal elimination rate constant (λz) - Formoterol - Day 1
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide
Accumulation ratio for Cmax (RAC \[Cmax\]) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium
Accumulation ratio for Cmax (RAC \[Cmax\]) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol
Accumulation ratio for Cmax (RAC \[Cmax\]) - Formoterol
Time frame: Day 1 and Day 8
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Budesonide
Time frame: Day 1 and Day 8
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Glycopyrronium
Time frame: Day 1 and Day 8
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Formoterol
Time frame: Day 1 and Day 8
Physical Exam Findings
Number of subjects with clinically significant changes in post baseline physical exam findings
Time frame: Visit 4, Day 8
Laboratory Tests
Number of subjects with clinically significant changes in post baseline laboratory tests
Time frame: Visit 4, Day 8
Electrocardiogram
Number of subjects with clinically significant changes in post baseline electrocardiogram
Time frame: Visit 4, Day 8
Serious Adverse Events/Adverse Events
Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal
Time frame: Visit 4, Day 8
Vital Signs
Number of subjects with clinically significant changes in post baseline vital signs
Time frame: Visit 4, Day 8
This study was conducted at a single site in China.
| Milestone | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Started | 32 | 32 | 32 |
| Completed | 31 | 32 | 32 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
Maximum plasma concentration (Cmax) of Budesonide Day 1
| pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Maximum Plasma Concentration (Cmax) - Budesonide | 459.308 ± 67.6 | 224.298 ± 98.1 |
Maximum plasma concentration (Cmax) of Budesonide Day 8
| pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Maximum Plasma Concentration (Cmax) - Budesonide | 626.435 ± 78.1 | 315.425 ± 80.2 |
Maximum plasma concentration (Cmax) of Glycopyrronium Day 1
| pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | 4.884 ± 92.5 | 5.286 ± 120.8 | 5.674 ± 113.4 |
Maximum plasma concentration (Cmax) of Glycopyrronium Day 8
| pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | 11.303 ± 96.9 | 11.754 ± 103.0 | 13.124 ± 82.3 |
Maximum plasma concentration (Cmax) of Formoterol Day 1
| pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Maximum Plasma Concentration (Cmax) - Formoterol | 9.651 ± 55.8 | 9.932 ± 71.9 | 10.618 ± 76.6 |
Maximum plasma concentration (Cmax) of Formoterol Day 8
| pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Maximum Plasma Concentration (Cmax) - Formoterol | 16.125 ± 59.1 | 16.945 ± 54.5 | 17.710 ± 57.6 |
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide | 1747.910 ± 43.5 | 811.812 ± 58.2 |
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide | 2509.888 ± 53.4 | 1249.615 ± 52.0 |
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium | 29.400 ± 23.5 | 27.197 ± 41.3 | 29.002 ± 42.6 |
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium | 69.487 ± 64.8 | 77.078 ± 47.5 | 72.636 ± 57.2 |
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol | 47.843 ± 35.0 | 46.492 ± 39.3 | 53.583 ± 38.0 |
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol | 81.936 ± 39.5 | 85.322 ± 34.0 | 83.499 ± 37.8 |
Time to maximum plasma concentration (tmax) - Budesonide Day 1
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Budesonide | 0.333 (0.10 to 2.00) | 0.333 (0.10 to 2.00) |
Time to maximum plasma concentration (tmax) - Budesonide Day 8
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Budesonide | 0.333 (0.10 to 4.00) | 0.333 (0.03 to 4.00) |
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium | 0.100 (0.03 to 2.00) | 0.100 (0.03 to 4.00) | 0.100 (0.03 to 4.00) |
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium | 0.333 (0.03 to 4.00) | 0.333 (0.03 to 4.00) | 0.333 (0.03 to 2.00) |
Time to maximum plasma concentration (tmax) - Formoterol Day 1
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Formoterol | 0.833 (0.10 to 2.00) | 0.100 (0.10 to 2.00) | 0.100 (0.10 to 2.00) |
Time to maximum plasma concentration (tmax) - Formoterol Day 8
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Formoterol | 0.100 (0.10 to 2.00) | 0.100 (0.10 to 4.00) | 0.100 (0.10 to 4.00) |
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide | 1884.912 ± 43.5 | 830.012 ± 61.1 |
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium | 17.616 ± 89.8 | 17.707 ± 111.2 | 20.287 ± 103.3 |
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol | 48.326 ± 41.4 | 47.408 ± 48.2 | 45.950 ± 78.1 |
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide | 1936.211 ± 42.0 | 876.673 ± 58.8 |
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium | 35.465 ± 19.6 | 33.014 ± NA | 43.537 ± 18.3 |
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
| h*pg/mL | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol | 61.617 ± 37.5 | 73.123 ± 40.5 | 70.608 ± 46.0 |
Elimination half-life (t½) - Budesonide Day 1
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Elimination Half-life (t½) - Budesonide | 4.572 ± 25.3 | 3.168 ± 31.9 |
Elimination half-life (t½) - Glycopyrronium Day 1
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Elimination Half-life (t½) - Glycopyrronium | 5.676 ± 52.5 | 8.539 ± 161.3 | 6.194 ± 108.2 |
Elimination half-life (t½) - Formoterol Day 1
| h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Elimination Half-life (t½) - Formoterol | 5.098 ± 22.7 | 5.657 ± 38.1 | 5.628 ± 34.2 |
Apparent total body clearance (CL/F) - Budesonide Day 1
| L/h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Apparent Total Body Clearance (CL/F) - Budesonide | 165.271 ± 42.0 | 182.508 ± 58.8 |
Apparent total body clearance (CL/F) - Glycopyrronium Day 1
| L/h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Apparent Total Body Clearance (CL/F) - Glycopyrronium | 406.038 ± 19.6 | 436.184 ± NA | 330.757 ± 18.3 |
Apparent total body clearance (CL/F) - Formoterol Day 1
| L/h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Apparent Total Body Clearance (CL/F) - Formoterol | 155.801 ± 37.5 | 131.286 ± 40.5 | 135.962 ± 46.0 |
Apparent volume of distribution (Vd/F) - Budesonide - Day 1
| L | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Apparent Volume of Distribution (Vd/F) - Budesonide | 1090.237 ± 43.0 | 834.269 ± 56.2 |
Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1
| L | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Apparent Volume of Distribution (Vd/F) - Glycopyrronium | 2172.038 ± 17.6 | 2123.999 ± NA | 1864.314 ± 49.8 |
Apparent volume of distribution (Vd/F) - Formoterol - Day 1
| L | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Apparent Volume of Distribution (Vd/F) - Formoterol | 1125.215 ± 26.0 | 1000.172 ± 29.2 | 1035.257 ± 30.9 |
Terminal elimination rate constant (λz) - Budesonide - Day 1
| 1/h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Terminal Elimination Rate Constant (λz) - Budesonide | 0.152 ± 25.3 | 0.219 ± 31.9 |
Terminal elimination rate constant (λz) - Glycopyrronium - Day 1
| 1/h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Terminal Elimination Rate Constant (λz) - Glycopyrronium | 0.122 ± 52.5 | 0.081 ± 161.3 | 0.112 ± 108.2 |
Terminal elimination rate constant (λz) - Formoterol - Day 1
| 1/h | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Terminal Elimination Rate Constant (λz) - Formoterol | 0.136 ± 22.7 | 0.123 ± 38.1 | 0.123 ± 34.2 |
Accumulation ratio for Cmax (RAC \[Cmax\]) - Budesonide
| Ratio | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide | 1.400 ± 71.4 | 1.406 ± 62.6 |
Accumulation ratio for Cmax (RAC \[Cmax\]) - Glycopyrronium
| Ratio | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium | 2.383 ± 86.4 | 2.319 ± 90.3 | 2.412 ± 89.7 |
Accumulation ratio for Cmax (RAC \[Cmax\]) - Formoterol
| Ratio | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol | 1.678 ± 50.1 | 1.706 ± 42.1 | 1.668 ± 62.2 |
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Budesonide
| Ratio | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg |
|---|---|---|
| Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide | 1.455 ± 45.9 | 1.539 ± 37.1 |
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Glycopyrronium
| Ratio | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium | 3.324 ± 47.5 | 3.030 ± 43.0 | 3.189 ± 31.5 |
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Formoterol
| Ratio | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol | 1.718 ± 28.7 | 1.835 ± 26.2 | 1.620 ± 27.5 |
Number of subjects with clinically significant changes in post baseline physical exam findings
| Participants | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Significant Findings | 0 | 0 | 0 |
Number of subjects with clinically significant changes in post baseline laboratory tests
| Participants | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Potassium | 0 | 1 | 0 |
Number of subjects with clinically significant changes in post baseline electrocardiogram
| Participants | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Significant electrocardiogram changes | 0 | 0 | 0 |
Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal
| Participants | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Serious TEAEs/TEAEs leading to withdrawal | 0 | 0 | 0 |
Number of subjects with clinically significant changes in post baseline vital signs
| Participants | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Bradycardia events | 2 | 0 | 0 |
Collected over Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PT010 (BGF MDI) 320/14.4/9.6 µg | 0/32 (0%) | 0/32 (0%) | 14/32 (43.8%) |
| PT010 (BGF MDI) 160/14.4/9.6 µg | 0/32 (0%) | 0/32 (0%) | 11/32 (34.4%) |
| PT003 (GFF MDI) 14.4/9.6 µg | 0/32 (0%) | 0/32 (0%) | 14/32 (43.8%) |
| Event | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg |
|---|---|---|---|
| Blood potassium increasedInvestigations | 2/32 | 1/32 | 5/32 |
| Blood glucose increasedInvestigations | 4/32 | 3/32 | 4/32 |
| Blood potassium decreasedInvestigations | 2/32 | 4/32 | 1/32 |
| Dry throatRespiratory, thoracic and mediastinal disorders | 3/32 | 2/32 | 4/32 |
| Sensation of foreign bodyGeneral disorders | 1/32 | 1/32 | 3/32 |
| Bilirubin conjugated increasedInvestigations | 0/32 | 1/32 | 2/32 |
| Blood bilirubin increasedInvestigations | 0/32 | 1/32 | 2/32 |
| Blood uric acid increasedInvestigations | 2/32 | 1/32 | 0/32 |
| Alanine aminotransferase increasedInvestigations | 0/32 | 0/32 | 2/32 |
| Blood glucose decreasedInvestigations | 2/32 | 0/32 | 0/32 |
Safety Population - all subjects who received at least 1 dose of any blinded study drug
| Age, Continuous(Years) | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg | Total |
|---|---|---|---|---|
| Mean | 25.1 ± 3.8 | 26.9 ± 5.1 | 24.7 ± 4.1 | 25.6 ± 4.4 |
| Sex: Female, Male(Participants) | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg | Total |
|---|---|---|---|---|
| Female | 7 | 6 | 3 | 16 |
| Male | 25 | 26 | 29 | 80 |
| Race/Ethnicity, Customized(Participants) | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg | Total |
|---|---|---|---|---|
| Chinese subjects | 32 | 32 | 32 | 96 |
| Smoking Status(Participants) | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg | Total |
|---|---|---|---|---|
| Non Smoker | 28 | 29 | 30 | 87 |
| Former Smoker | 4 | 3 | 2 | 9 |
| Weight(kg) | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg | Total |
|---|---|---|---|---|
| Mean | 59.99 ± 5.29 | 60.00 ± 6.13 | 62.75 ± 5.31 | 60.91 ± 5.68 |
| BMI(kg/m^2) | PT010 (BGF MDI) 320/14.4/9.6 µg | PT010 (BGF MDI) 160/14.4/9.6 µg | PT003 (GFF MDI) 14.4/9.6 µg | Total |
|---|---|---|---|---|
| Median | 21.5 ± 1.4 | 21.6 ± 1.2 | 21.9 ± 1.1 | 21.7 ± 1.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Apr 2017 to primary completion in Sep 2017, 4 months.
Results were first posted in Jan 2021, 3 years 4 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 4 months is close to 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 Dec 2020. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →