A Phase 3 interventional study of GFF MDI (PT003) and GP MDI (PT001) in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Pearl Therapeutics, Inc.. Completed at 114 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-28.
Sponsored by Pearl Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.
2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 1,615 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive 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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
FF MDI administered as two puffs BID
Drug: FF MDI (PT005)
GP MDI administered as two puffs BID
Drug: GP MDI (PT001)
GFF MDI administered as two puffs BID
Drug: GFF MDI (PT003)
Inhaled placebo administered as two puffs BID
Drug: Placebo
GFF MDI administered as two puffs BID
Also known as: glycopyrrolate/formoterol fumarate metered-dose inhaler, (GFF MDI)
GP MDI administered as two puffs BID
Also known as: glycopyrrolate metered dose inhaler (GP MDI)
FF MDI administered as two puffs BID
Also known as: formoterol fumarate metered dose inhaler (FF MDI)
Change From Baseline in Morning Pre-dose Trough FEV1
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.
Time frame: At Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Time frame: Over 24 weeks
Peak FEV1
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24
Time frame: At week 24
St. George Respiratory Questionnaire (SGRQ) Score
Change from baseline in the SGRQ total score at Week 24. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo 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. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Time frame: 24 weeks
Rescue Ventolin HFA Use
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Time frame: 24 weeks
Onset of Action as Assessed by FEV1
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
Time frame: Day 1
Conducted at 140 sites throughout the United States from July 2013 - February 2015. Study participation was a maximum of 32 weeks.
| Milestone | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| Started | 439 | 440 | 512 | 224 |
| Completed | 346 | 365 | 432 | 165 |
| Not completed | 93 | 75 | 80 | 59 |
| Withdrew: Protocol violation | 6 | 2 | 2 | 1 |
| Withdrew: Physician decision | 7 | 5 | 2 | 4 |
| Withdrew: Lost to follow-up | 8 | 9 | 8 | 4 |
| Withdrew: Withdrawal by subject | 28 | 21 | 29 | 15 |
| Withdrew: Protocol-specified criteria | 15 | 15 | 10 | 7 |
| Withdrew: Lack of efficacy | 3 | 8 | 4 | 7 |
| Withdrew: Adverse event | 21 | 14 | 23 | 19 |
| Withdrew: Administrative reasons | 5 | 1 | 2 | 2 |
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.
| Liters | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 | 0.061 (0.039 to 0.082) | 0.063 (0.041 to 0.084) | 0.116 (0.097 to 0.136) | 0.013 (-0.018 to 0.044) |
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
| Liters | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks | 0.080 (0.064 to 0.095) | 0.082 (0.067 to 0.097) | 0.137 (0.123 to 0.151) | 0.008 (-0.014 to 0.030) |
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24
| Liters | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| Peak FEV1 | 0.268 (0.244 to 0.292) | 0.223 (0.199 to 0.247) | 0.350 (0.328 to 0.371) | 0.083 (0.048 to 0.117) |
Change from baseline in the SGRQ total score at Week 24. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo 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. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
| Scores on a scale | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| St. George Respiratory Questionnaire (SGRQ) Score | -2.3 (-3.5 to -1.1) | -2.2 (-3.4 to -1.0) | -3.0 (-4.1 to -1.8) | -1.2 (-3.0 to 0.5) |
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
| Puffs / Day | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| Rescue Ventolin HFA Use | -0.7 (-0.9 to -0.5) | -0.4 (-0.6 to -0.3) | -1.0 (-1.2 to -0.8) | 0.0 (-0.2 to 0.3) |
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
| Liters | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| 5 min post dose | 0.175 (0.163 to 0.188) | 0.052 (0.040 to 0.065) | 0.192 (0.180 to 0.204) | 0.006 (-0.012 to 0.024) |
| 15 min post dose | 0.212 (0.199 to 0.225) | 0.109 (0.096 to 0.122) | 0.237 (0.225 to 0.249) | 0.022 (0.003 to 0.040) |
Collected over Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FF MDI (PT005) | — | 37/438 (8.4%) | 21/438 (4.8%) |
| GP MDI (PT001) | — | 37/439 (8.4%) | 12/439 (2.7%) |
| GFF MDI (PT003) | — | 36/510 (7.1%) | 22/510 (4.3%) |
| Placebo MDI | — | 15/223 (6.7%) | 10/223 (4.5%) |
| Event | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 8/438 | 9/439 | 8/510 | 4/223 |
| PneumoniaInfections and infestations | 4/438 | 4/439 | 2/510 | 3/223 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/438 | 0/439 | 1/510 | 2/223 |
| Myocardial infarctionCardiac disorders | 0/438 | 0/439 | 0/510 | 2/223 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/438 | 1/439 | 3/510 | 0/223 |
| Atrial fibrillationCardiac disorders | 0/438 | 2/439 | 3/510 | 0/223 |
| Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/438 | 0/439 | 0/510 | 1/223 |
| Small intestinal obstructionGastrointestinal disorders | 2/438 | 0/439 | 0/510 | 0/223 |
| Non-cardiac chest painGeneral disorders | 2/438 | 0/439 | 1/510 | 0/223 |
| Cardiac failure congestiveCardiac disorders | 0/438 | 2/439 | 0/510 | 0/223 |
| Event | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 21/438 | 12/439 | 22/510 | 10/223 |
5 subjects participated in more than one Phase 3 Pearl study (a protocol violation) and had overlapping treatment exposure - these subjects were removed from the ITT and safety populations; 1 subject participated in more than one Phase 3 Pearl study but did not have overlapping treatment exposure - this subject was removed from the ITT population
| Age, Continuous(Years) | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI | Total |
|---|---|---|---|---|---|
| Mean | 62.6 ± 7.8 | 62.8 ± 8.4 | 62.8 ± 8.2 | 64.2 ± 8.7 | 62.9 ± 8.3 |
| Sex: Female, Male(Participants) | FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Placebo MDI | Total |
|---|---|---|---|---|---|
| Female | 190 | 197 | 238 | 98 | 723 |
| Male | 247 | 242 | 272 | 125 | 886 |
Showing the first 100 of 114 sites.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Pearl Therapeutics, Inc.