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 741 sites in 26 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-02.
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 has the largest enrollment, is one of 7 that started in 2015, is one of 15 in phase 3, and was the 22nd registered.
5,521 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 8,588 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.
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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 has the largest 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 171st 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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This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.
A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.
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 inclusion 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.
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.
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.
BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
Drug: BGF MDI 320/14.4/9.6 μg
BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
Drug: BGF MDI 160/14.4/9.6 μg
BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
Drug: BFF MDI 320/9.6 μg
GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)
Drug: GFF MDI 14.4/9.6 μg
Drug pages: Budesonide · Glycopyrrolate · Formoterol
Budensonide, Glycopyrronium, and Formoterol Fumarate
Also known as: BGF
Glycopyrronium, and Formoterol Fumarate
Also known as: GFF
Drug pages: Budesonide · Glycopyrrolate · Formoterol
Budensonide, Glycopyrronium, and Formoterol Fumarate
Also known as: BGF
Drug pages: Budesonide · Formoterol
Budensonide, and Formoterol Fumarate
Also known as: BFF
Adjusted Rate of Moderate or Severe Exacerbations
Adjusted Rate of Moderate or Severe Exacerbations
Time frame: 52-week treatment period
Time to First Moderate or Severe COPD Exacerbation
Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)
Time frame: 52 Weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Time frame: 24 Weeks
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score
Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24
Time frame: at Week 24
Time to Death (All Cause)
Subject Deaths (all cause)
Time frame: 52 Weeks
Rate of Severe COPD Exacerbations
Rate of severe COPD exacerbations
Time frame: 52 Weeks
This study was conducted in 26 countries between July 2015 and July 2019.
| Milestone | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Started | 2157 | 2137 | 2143 | 2151 |
| Completed | 1708 | 1713 | 1580 | 1643 |
| Not completed | 449 | 424 | 563 | 508 |
| Withdrew: Adverse event | 118 | 113 | 147 | 138 |
| Withdrew: Lack of efficacy | 103 | 102 | 171 | 135 |
| Withdrew: Withdrawal by subject | 104 | 94 | 123 | 130 |
| Withdrew: Physician decision | 23 | 33 | 38 | 28 |
| Withdrew: Major protocol deviation | 24 | 26 | 22 | 25 |
| Withdrew: Lost to follow-up | 25 | 21 | 19 | 15 |
| Withdrew: Protocol specified criteria | 20 | 10 | 9 | 12 |
| Withdrew: Administrative reasons | 12 | 9 | 11 | 5 |
| Withdrew: Randomized but not treated | 1 | 5 | 4 | 5 |
| Withdrew: Enrolled in >1 studies | 18 | 11 | 19 | 15 |
| Withdrew: Missing pi signature | 1 | 0 | 0 | 0 |
Adjusted Rate of Moderate or Severe Exacerbations
| Moderate or Severe Exacerbations | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Adjusted Rate of Moderate or Severe Exacerbations | 1.08 ± 0.04 | 1.07 ± 0.04 | 1.42 ± 0.05 | 1.24 ± 0.04 |
Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)
| Participants | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Time to First Moderate or Severe COPD Exacerbation | 1026 | 1013 | 1056 | 1085 |
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
| Puffs | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks | -1.2 (-1.3 to -1.1) | -1.0 (-1.2 to -0.9) | -0.7 (-0.8 to -0.5) | -0.8 (-0.9 to -0.7) |
Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24
| Participants | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score | 1068 | 1024 | 893 | 949 |
Subject Deaths (all cause)
| Participants | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Time to Death (All Cause) | 28 | 39 | 49 | 34 |
Rate of severe COPD exacerbations
| Severe Exacerbations | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Rate of Severe COPD Exacerbations | 0.13 ± 0.01 | 0.14 ± 0.01 | 0.15 ± 0.01 | 0.16 ± 0.01 |
Collected over Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BGF MDI 320/14.4/9.6 μg | 27/2,144 (1.3%) | 426/2,144 (19.9%) | 337/2,144 (15.7%) |
| BGF MDI 160/14.4/9.6 μg | 42/2,124 (2%) | 445/2,124 (21%) | 361/2,124 (17%) |
| GFF MDI 14.4/9.6 μg | 47/2,125 (2.2%) | 433/2,125 (20.4%) | 292/2,125 (13.7%) |
| BFF MDI 320/9.6 μg | 35/2,136 (1.6%) | 440/2,136 (20.6%) | 336/2,136 (15.7%) |
| Event | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 202/2144 | 221/2124 | 219/2125 | 241/2136 |
| PneumoniaInfections and infestations | 61/2144 | 59/2124 | 35/2125 | 55/2136 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 14/2144 | 20/2124 | 20/2125 | 7/2136 |
| Acute myocardial infarctionCardiac disorders | 7/2144 | 10/2124 | 17/2125 | 7/2136 |
| Atrial fibrilationCardiac disorders | 9/2144 | 8/2124 | 14/2125 | 3/2136 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 10/2144 | 9/2124 | 5/2125 | 9/2136 |
| Cardiac arrestCardiac disorders | 3/2144 | 1/2124 | 8/2125 | 0/2136 |
| Cerebrovascular accidentNervous system disorders | 8/2144 | 2/2124 | 4/2125 | 3/2136 |
| Myocardial infarctionCardiac disorders | 5/2144 | 5/2124 | 7/2125 | 4/2136 |
| Coronary artery diseaseCardiac disorders | 5/2144 | 5/2124 | 7/2125 | 1/2136 |
| Event | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 227/2144 | 239/2124 | 199/2125 | 234/2136 |
| Upper respiratory tract infectionInfections and infestations | 123/2144 | 137/2124 | 102/2125 | 115/2136 |
mITT population
| Age, Continuous(Years) | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg | Total |
|---|---|---|---|---|---|
| Mean | 64.6 ± 7.6 | 64.6 ± 7.6 | 64.8 ± 7.6 | 64.6 ± 7.6 | 64.7 ± 7.6 |
| Sex: Female, Male(Participants) | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg | Total |
|---|---|---|---|---|---|
| Female | 877 | 823 | 876 | 852 | 3428 |
| Male | 1260 | 1298 | 1244 | 1279 | 5081 |
| Ethnicity (NIH/OMB)(Participants) | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 400 | 393 | 426 | 401 | 1620 |
| Not Hispanic or Latino | 1690 | 1680 | 1649 | 1683 | 6702 |
| Unknown or Not Reported | 47 | 48 | 45 | 47 | 187 |
| Race (NIH/OMB)(Participants) | BGF MDI 320/14.4/9.6 μg | BGF MDI 160/14.4/9.6 μg | GFF MDI 14.4/9.6 μg | BFF MDI 320/9.6 μg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 33 | 40 | 30 | 39 | 142 |
| Asian | 162 | 166 | 157 | 166 | 651 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 0 | 0 | 2 |
| Black or African American | 78 | 88 | 75 | 64 | 305 |
| White | 1819 | 1783 | 1808 | 1816 | 7226 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 43 | 44 | 50 | 46 | 183 |
Showing the first 100 of 741 sites across 26 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2015 to primary completion in Jul 2019, 48 months.
Results were first posted in Feb 2021, 1 year 6 months after primary completion. A results delay was requested in May 2020.
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 48 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 →