A Phase 3 interventional study of BGF MDI 320/14.4/9.6 μg and GFF MDI 14.4/9.6 μg in COPD, sponsored by Pearl Therapeutics, Inc.. Completed at 64 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-26.
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 8th largest by enrollment, is one of 7 that started in 2015, is one of 15 in phase 3, and was the 26th 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; 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.
43 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 7 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 627 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 51st largest by enrollment of the 194 interventional ones that give a count, is one of 19 that started in 2015, is one of 76 in phase 3, and was the 175th 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:
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Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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.
Given their signed written to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)
Exclusion Criteria:
Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery
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.
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.
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
Drug: BGF MDI 320/14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
Drug: GFF MDI 14.4/9.6 μg
Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)
Drug: BFF MDI 320/9.6 μg
Drug pages: Budesonide · Glycopyrrolate · Formoterol
Budesonide, Glycopyrronium, and Formoterol Fumarate
Also known as: BGF MDI
Glycopyrronium and Formoterol Fumarate
Also known as: GFF MDI
Drug pages: Budesonide · Formoterol
Budesonide and Formoterol Fumarate
Also known as: BFF MDI
Percent Change From Baseline in BMD of the Lumbar Spine
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Time frame: at week 52
Change From Baseline in the LOCS III (P) Score at Week 52
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.
Time frame: at week 52
The study randomized subjects at 69 sites in the United States from September 2015 to September 2017. The entire study period was scheduled to take up to approximately 58 weeks for each individual subject from the time of screening through the follow-up period.
| Milestone | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug |
|---|---|---|---|
| Started | 194 | 174 | 88 |
| Completed | 142 | 130 | 65 |
| Not completed | 52 | 44 | 23 |
| Withdrew: Withdrawal by subject | 18 | 13 | 7 |
| Withdrew: Adverse event | 14 | 13 | 6 |
| Withdrew: Lost to follow-up | 12 | 4 | 0 |
| Withdrew: Lack of efficacy | 3 | 5 | 4 |
| Withdrew: Protocol discontinuation criteria | 3 | 2 | 2 |
| Withdrew: Physician decision | 0 | 4 | 2 |
| Withdrew: Major protocol deviation | 2 | 2 | 2 |
| Withdrew: Administrative reasons | 0 | 1 | 0 |
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
| Percentage | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug |
|---|---|---|---|
| Percent Change From Baseline in BMD of the Lumbar Spine | -0.093 (-0.739 to 0.557) | 0.379 (-0.28 to 1.042) | -0.120 (-1.087 to 0.857) |
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.
| P-Score | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug |
|---|---|---|---|
| Change From Baseline in the LOCS III (P) Score at Week 52 | 0.153 (0.079 to 0.227) | .026 (-0.055 to 0.106) | 0.022 (-0.090 to 0.135) |
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. 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 54 weeks.. Non-serious events are listed at a 5.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BGF MDI 320/14.4/9.6 ug | 3/194 (1.5%) | 33/194 (17%) | 62/194 (32%) |
| GFF MDI 14.4/9.6 ug | 1/174 (0.6%) | 22/174 (12.6%) | 51/174 (29.3%) |
| BFF MDI 320/9.6 ug | 0/88 (0%) | 7/88 (8%) | 30/88 (34.1%) |
| Event | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug |
|---|---|---|---|
| Chronic Pulmonary Obstructive DiseaseRespiratory, thoracic and mediastinal disorders | 12/194 | 9/174 | 2/88 |
| PneumoniaInfections and infestations | 2/194 | 4/174 | 0/88 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/194 | 2/174 | 0/88 |
| Acute Myocardial InfarctionCardiac disorders | 0/194 | 2/174 | 0/88 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/194 | 0/174 | 1/88 |
| BronchitisInfections and infestations | 1/194 | 0/174 | 1/88 |
| Atrioventricular block completeCardiac disorders | 1/194 | 0/174 | 1/88 |
| Supraventricular tachycardiaCardiac disorders | 0/194 | 0/174 | 1/88 |
| Peripheral vascular disorderVascular disorders | 0/194 | 0/174 | 1/88 |
| CellulitisInfections and infestations | 1/194 | 0/174 | 1/88 |
| Event | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug |
|---|---|---|---|
| Upper Respiratory Tract InfectionInfections and infestations | 18/194 | 17/174 | 6/88 |
| Viral Upper Respiratory Tract InfectionInfections and infestations | 9/194 | 5/174 | 6/88 |
| BronchitisInfections and infestations | 12/194 | 8/174 | 2/88 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 6/194 | 2/174 | 5/88 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/194 | 5/174 | 5/88 |
| Muscle SpasmsMusculoskeletal and connective tissue disorders | 6/194 | 2/174 | 5/88 |
| SinusitisInfections and infestations | 11/194 | 6/174 | 2/88 |
| DiarrhoeaGastrointestinal disorders | 5/194 | 9/174 | 2/88 |
| Urinary Tract InfectionInfections and infestations | 10/194 | 6/174 | 4/88 |
The Safety Population included only subjects who signed ICF for Study PT010008 and received any amount of study drug (other than Symbicort).
| Age, Continuous(Years) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Total |
|---|---|---|---|---|
| Mean | 62.6 ± 7.9 | 62.4 ± 7.8 | 64.0 ± 7.2 | 62.8 ± 7.7 |
| 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 | Total |
|---|---|---|---|---|
| Female | 92 | 87 | 35 | 214 |
| Male | 102 | 87 | 53 | 242 |
| 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 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 9 | 5 | 6 | 20 |
| Not Hispanic or Latino | 185 | 169 | 82 | 436 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Total |
|---|---|---|---|---|
| Black | 13 | 17 | 9 | 39 |
| White | 179 | 156 | 79 | 414 |
| Asian | 0 | 1 | 0 | 1 |
| Other | 2 | 0 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Aug 2015 to primary completion in Sep 2017, 25 months.
Results were first posted in Feb 2021, 3 years 5 months after primary completion. A results delay was requested in Aug 2018.
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 25 months is above 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 Jan 2021. 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 →