A Phase 3 interventional study of BGF MDI (PT010) and GFF MDI (PT003) in COPD, sponsored by Pearl Therapeutics, Inc.. Completed at 79 sites in Japan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Pearl Therapeutics, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment
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Among 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive — 3 open to participants now, 3 under way, 1 of them phase 3. Budesonide · Pulmonary Disease, Chronic Obstructive.
Among the 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive, this one is the 9th largest by enrollment, is one of 4 that started in 2016, is one of 15 in phase 3, and was the 27th 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 →3 of the 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Germany, United Kingdom
Ages 40–80
Maria Joyera Rodríguez · Sites in Germany, Netherlands, Spain and 1 more country
Ages 40+
AstraZeneca · Sites in United States, Argentina, Australia and 34 more countries
Ages 40–80
By country, each count listing its studies:
Budesonide: first FDA approval 1994 (RHINOCORT), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
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; 89 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.
43 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 4 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 416 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 99 across the 43 interventional studies. Of the 37 that completed or were terminated, 16 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 43 have an industry lead sponsor. The 10 most frequent:
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.
284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca: 14 open now, 15 under way, 4 of them phase 3. Of 264 finished, 127 (48%) have results posted.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 67th largest by enrollment of the 194 interventional ones that give a count, is one of 20 that started in 2016, is one of 76 in phase 3, and was the 181st registered.
AstraZeneca’s Pulmonary Disease, Chronic Obstructive studies by the year they started, since 1999.
1 of the studies testing budesonide in Pulmonary Disease, Chronic Obstructive that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| 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 |
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Among the 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 284 in Pulmonary Disease, Chronic Obstructive:
This tab as a report to print or save as PDF → With an account.
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®
This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators.
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.
Please refer to the study protocol for the complete inclusion criteria list.
Exclusion Criteria
Please refer to the study protocol for the complete exclusion criteria list.
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.
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.
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.
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.
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.
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.
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
Drug: BGF MDI (PT010)
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
Drug: GFF MDI (PT003)
Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
Drug: BFF MDI (PT009)
Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
Drug: Symbicort® Turbohaler® Inhalation Powder
Drug pages: Budesonide · Glycopyrrolate · Formoterol
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
Also known as: BGF
Drug pages: Glycopyrrolate · Formoterol
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
Also known as: GFF
Drug pages: Budesonide · Formoterol
Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
Also known as: BFF
Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
Also known as: Symbicort
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values
Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
Time frame: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Time frame: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Time frame: 28 Weeks
This study was conducted at 75 study centers in Japan, from Aug 2016 to June 2018. This is an extension study of PT010006 and could take up to an additional 28 weeks.
| Milestone | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug BID |
|---|---|---|---|---|
| Started | 139 | 138 | 70 | 69 |
| Completed | 112 | 102 | 56 | 54 |
| Not completed | 27 | 36 | 14 | 15 |
| Withdrew: Withdrawal by subject | 15 | 13 | 8 | 7 |
| Withdrew: Adverse event | 10 | 12 | 4 | 6 |
| Withdrew: Physician decision | 2 | 5 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 5 | 1 | 2 |
| Withdrew: Protocol discontinuation criteria | 0 | 1 | 0 | 0 |
Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
| Count of Participants | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug |
|---|---|---|---|---|
| ALT >3 x ULN | 0 | 1 | 0 | 0 |
| Total Bilirubin >2 x ULN | 0 | 0 | 0 | 1 |
| Potassium (mmol/L) >6.0 | 2 | 0 | 0 | 0 |
| Glucose (mmol/L) >13.9 if Baseline is ≤10.0 | 0 | 1 | 1 | 1 |
| Glucose (mmol/L) >16.7 if baseline is >10.0 | 0 | 1 | 0 | 0 |
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
| Particpants | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug |
|---|---|---|---|---|
| Systolic Blood Pressure >=180, Incr >=20 | 3 | 1 | 0 | 0 |
| Systolic Blood Pressure, <=90, Decr >=20 | 4 | 1 | 1 | 1 |
| Diastolic Blood Pressure, >=105 Incr, >=15 | 2 | 1 | 2 | 0 |
| Diastolic Blood Pressure, <=50, Decr >=15 | 4 | 3 | 2 | 3 |
| Tachycardia Event >=110, Incr >=15% | 1 | 0 | 2 | 0 |
| Bradycardia Event <=50, Decr >=15% | 9 | 8 | 3 | 2 |
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
| Participants | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug |
|---|---|---|---|---|
| >=500 if <500 msec at BL and change >=15 msec | 1 | 0 | 0 | 0 |
| >=530 if >=500 msec at BL and >=15 msec | 0 | 0 | 0 | 0 |
| >= 500 msec and >= 15 msec change from BL | 1 | 0 | 0 | 0 |
| Increase from baseline is >=60 msec | 1 | 1 | 0 | 0 |
| Value is >500 msec and increase >=60 msec | 0 | 0 | 0 | 0 |
Collected over Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BGF MDI 320/14.4/9.6 ug | 3/139 (2.2%) | 21/139 (15.1%) | 82/139 (59%) |
| GFF MDI 14.4/9.6 ug | 1/138 (0.7%) | 30/138 (21.7%) | 75/138 (54.3%) |
| BFF MDI 320/9.6 ug | 1/70 (1.4%) | 11/70 (15.7%) | 40/70 (57.1%) |
| Symbicort TBH 400/12 ug BID | 1/69 (1.4%) | 14/69 (20.3%) | 38/69 (55.1%) |
| Event | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug BID |
|---|---|---|---|---|
| Chronic obstructive pulmonary disorderRespiratory, thoracic and mediastinal disorders | 7/139 | 11/138 | 2/70 | 2/69 |
| PneumoniaInfections and infestations | 8/139 | 3/138 | 1/70 | 2/69 |
| Acute myocardial infarctionCardiac disorders | 0/139 | 0/138 | 0/70 | 2/69 |
| Large intestine polypGastrointestinal disorders | 0/139 | 0/138 | 1/70 | 2/69 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/139 | 2/138 | 1/70 | 0/69 |
| Herpes zosterInfections and infestations | 0/139 | 0/138 | 0/70 | 1/69 |
| SepsisInfections and infestations | 0/139 | 0/138 | 0/70 | 1/69 |
| Adenocarcinoma gastricNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/139 | 0/138 | 0/70 | 1/69 |
| LymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/139 | 0/138 | 0/70 | 1/69 |
| Acute coronary syndromeCardiac disorders | 0/139 | 0/138 | 0/70 | 1/69 |
| Event | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug BID |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 45/139 | 43/138 | 22/70 | 24/69 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 10/139 | 1/138 | 9/70 | 3/69 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 16/139 | 6/138 | 6/70 | 3/69 |
| BronchitisInfections and infestations | 14/139 | 11/138 | 8/70 | 7/69 |
| InfluenzaInfections and infestations | 5/139 | 6/138 | 3/70 | 6/69 |
| Upper respiratory tract infectionInfections and infestations | 10/139 | 8/138 | 1/70 | 2/69 |
| Upper Respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 5/139 | 7/138 | 5/70 | 0/69 |
| EczemaSkin and subcutaneous tissue disorders | 1/139 | 3/138 | 4/70 | 4/69 |
| ConstipationGastrointestinal disorders | 6/139 | 5/138 | 4/70 | 2/69 |
Japanese Safety Population
| Age, Continuous(Years) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug BID | Total |
|---|---|---|---|---|---|
| Mean | 69.4 ± 7.1 | 69.0 ± 6.1 | 69.7 ± 6.1 | 70.1 ± 6.8 | 69.5 ± 6.5 |
| Sex: Female, Male(Participants) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug BID | Total |
|---|---|---|---|---|---|
| Female | 9 | 12 | 2 | 1 | 24 |
| Male | 130 | 126 | 68 | 68 | 392 |
| Ethnicity (NIH/OMB)(Participants) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug BID | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 139 | 138 | 69 | 69 | 415 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug BID | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 139 | 138 | 70 | 69 | 416 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Aug 2016 to primary completion in Jun 2018, 22 months.
Results were first posted in May 2020, 1 year 10 months after primary completion. A results delay was requested in Mar 2019.
Of 108 industry-sponsored phase 3 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 36. This study's 22 months is close to that.
Counting every sponsor, half of 141 studies reached it within 23 months; a quarter within 14 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Budesonide · Glycopyrrolate · Formoterol
Pulmonary Disease, Chronic Obstructive →