A Phase 3 interventional study of BFF MDI (PT009) 320/9.6 μg and BFF MDI (PT009) 160/9.6 μg in Chronic Obstructive Pulmonary Disorder, sponsored by Pearl Therapeutics, Inc.. Completed at 282 sites in 19 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Pearl Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 1,876 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI (PT009) 160/9.6 μg
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: FF MDI (PT005) 9.6 μg
Blinded Treatment
Also known as: Budesonide and Formoterol Fumarate Inhalation Aerosol
Blinded Treatment
Also known as: Budesonide and Formoterol Fumarate Inhalation Aerosol
Blinded Treatment
Also known as: Formoterol Fumarate Inhalation
Morning Pre-dose Trough FEV1
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
Time frame: at Week 12
Time to First Moderate or Severe COPD Exacerbation
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
Time frame: over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
Time frame: over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
Time frame: at Week 12
This study screened subjects at 292 study centers in 18 countries and randomized subjects at 259 study centers, from April 2016 to April 2018.
| Milestone | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
| Started | 619 | 617 | 607 |
| Completed | 503 | 501 | 442 |
| Not completed | 116 | 116 | 165 |
| Withdrew: Lack of efficacy | 40 | 40 | 70 |
| Withdrew: Adverse event | 28 | 21 | 32 |
| Withdrew: Withdrawal by subject | 26 | 25 | 30 |
| Withdrew: Physician decision | 3 | 8 | 14 |
| Withdrew: Lost to follow-up | 5 | 9 | 8 |
| Withdrew: Protocol violation | 7 | 5 | 5 |
| Withdrew: Protocol specified disc. criteria | 5 | 5 | 2 |
| Withdrew: Administrative reasons | 2 | 3 | 4 |
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
| Liter | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
| Morning Pre-dose Trough FEV1 | 0.072 (0.053 to 0.090) | 0.069 (0.051 to 0.087) | 0.037 (0.018 to 0.056) |
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
| Percentage of Subjects with Exacerbation | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
| Percent of Subjects Exacerbated within 12 Weeks | 19.2 (16.2 to 22.6) | 19.3 (16.3 to 22.7) | 24.8 (21.5 to 28.6) |
| Percent of Subjects Exacerbated within 24 Weeks | 31.2 (27.5 to 35.4) | 32.9 (29.1 to 37.1) | 35.1 (31.3 to 39.4) |
| Percent of Subjects Exacerbated within 36 Weeks | 41.0 (36.5 to 45.9) | 41.3 (36.9 to 46.0) | 46.2 (41.5 to 51.2) |
| Percent of Subjects Exacerbated within 52 Weeks | 50.1 (44.4 to 56.0) | 48.6 (43.1 to 54.4) | 54.8 (49.0 to 60.7) |
Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
| Puffs per day | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
| Change From Baseline in Average Daily Rescue Ventolin HFA Use | -0.9 (-1.1 to -0.7) | -0.9 (-1.1 to -0.7) | -0.6 (-0.8 to -0.4) |
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
| Percentage of Subjects | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
| Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score | 52 | 54 | 44 |
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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BFF MDI 320/9.6 ug | 3/619 (0.5%) | 60/619 (9.7%) | 266/619 (43%) |
| BFF MDI 160/9.6 ug | 4/617 (0.6%) | 78/617 (12.6%) | 279/617 (45.2%) |
| FF MDI 9.6 ug | 8/607 (1.3%) | 83/607 (13.7%) | 268/607 (44.2%) |
| Event | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 27/619 | 30/617 | 50/607 |
| PneumoniaInfections and infestations | 6/619 | 12/617 | 9/607 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/619 | 2/617 | 6/607 |
| Acute myocardial infarctionCardiac disorders | 0/619 | 0/617 | 4/607 |
| Atrial fibrilationCardiac disorders | 0/619 | 3/617 | 0/607 |
| Inguinal herniaGastrointestinal disorders | 0/619 | 3/617 | 0/607 |
| SepsisInfections and infestations | 1/619 | 0/617 | 2/607 |
| Cardiac arrestCardiac disorders | 0/619 | 0/617 | 2/607 |
| Small intestinal obstructionGastrointestinal disorders | 1/619 | 2/617 | 2/607 |
| Abdominal painGastrointestinal disorders | 0/619 | 2/617 | 2/607 |
| Event | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 41/619 | 53/617 | 36/607 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 27/619 | 30/617 | 50/607 |
| Upper respiratory tract infectionInfections and infestations | 28/619 | 14/617 | 24/607 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 23/619 | 16/617 | 16/607 |
| PneumoniaInfections and infestations | 14/619 | 19/617 | 15/607 |
| InfluenzaInfections and infestations | 15/619 | 19/617 | 10/607 |
| HeadacheNervous system disorders | 16/619 | 19/617 | 18/607 |
| Urinary tract infectionInfections and infestations | 10/619 | 18/617 | 13/607 |
| Back painMusculoskeletal and connective tissue disorders | 15/619 | 17/617 | 11/607 |
| HypertensionVascular disorders | 15/619 | 15/617 | 14/607 |
The Intent-To-Treat (ITT) Population is defined as all subjects who were randomized to treatment (presented here). The Modified Intent-To-Treat (mITT) Population, a subset of the ITT Population, is defined as all subjects with post-randomization data obtained prior to d/c from treatment. The mITT Population was used for all efficacy analyses.
| Age, Continuous(Years) | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug | Total |
|---|---|---|---|---|
| Mean | 65.3 ± 8.1 | 64.5 ± 8.4 | 64.8 ± 8.5 | 64.9 ± 8.3 |
| Sex: Female, Male(Participants) | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug | Total |
|---|---|---|---|---|
| Female | 252 | 272 | 268 | 792 |
| Male | 367 | 345 | 339 | 1051 |
| Ethnicity (NIH/OMB)(Participants) | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug | Total |
|---|---|---|---|---|
| Hispanic or Latino | 190 | 200 | 190 | 580 |
| Not Hispanic or Latino | 423 | 414 | 412 | 1249 |
| Unknown or Not Reported | 6 | 3 | 5 | 14 |
| Race (NIH/OMB)(Participants) | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 26 | 18 | 24 | 68 |
| Asian | 1 | 7 | 4 | 12 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 30 | 22 | 29 | 81 |
| White | 514 | 516 | 504 | 1534 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 47 | 54 | 46 | 147 |
Showing the first 100 of 282 sites across 19 countries.
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Pearl Therapeutics, Inc.