A Phase 3 interventional study of GFF MDI and GP MDI in Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics, Inc.. Completed at 140 sites in 3 countries. 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
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 2,103 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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)
Drug: GFF MDI
Glycopyrronium (GP) MDI (PT001)
Drug: GP MDI
Formoterol Fumarate (FF) MDI (PT005)
Drug: FF MDI
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Placebo MDI
Drug: Placebo MDI
GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
GP MDI administered as two puffs BID
FF MDI administered as two puffs BID
Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Inhaled placebo administered as two puffs BID
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Time frame: Baseline and 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 modelbased 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: Baseline and Weeks 2 to 24
St. George's Respiratory Questionnaire (SGRQ) Score
Change from baseline in the SGRQ total score. 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: Baseline and at Week 24
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Change from baseline in average daily rescue Ventolin HFA use
Time frame: Baseline and at Week 24
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: Assessed for 5- and 15-minute post dose on Day 1
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
Time frame: Baseline and at Week 24
Conducted at 160 sites throughout the US, Australia, and New Zealand from June 2013 - February 2015. Study participation was a maximum of 32 weeks.
| Milestone | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| Started | 527 | 451 | 452 | 453 | 220 |
| Completed | 429 | 345 | 370 | 391 | 160 |
| Not completed | 98 | 106 | 82 | 62 | 60 |
| Withdrew: Protocol-specified criteria | 13 | 10 | 8 | 5 | 7 |
| Withdrew: Administrative reasons / missing | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Protocol violation | 3 | 0 | 5 | 4 | 1 |
| Withdrew: Lost to follow-up | 10 | 7 | 8 | 5 | 0 |
| Withdrew: Physician decision | 1 | 5 | 3 | 3 | 7 |
| Withdrew: Withdrawal by subject | 31 | 41 | 30 | 21 | 24 |
| Withdrew: Lack of efficacy | 7 | 12 | 9 | 3 | 9 |
| Withdrew: Adverse event | 33 | 31 | 19 | 20 | 11 |
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
| Liters | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 | 0.126 (0.107 to 0.145) | 0.066 (0.045 to 0.087) | 0.062 (0.041 to 0.082) | 0.105 (0.084 to 0.125) | -0.024 (-0.055 to 0.007) |
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 modelbased 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 | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks | 0.150 (0.136 to 0.164) | 0.091 (0.076 to 0.106) | 0.086 (0.071 to 0.101) | 0.122 (0.107 to 0.137) | -0.007 (-0.029 to 0.015) |
Change from baseline in the SGRQ total score. 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 | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) Score | -3.1 (-4.0 to -2.2) | -1.2 (-2.2 to -0.2) | -2.4 (-3.4 to -1.4) | -2.7 (-3.6 to -1.7) | -0.8 (-2.2 to 0.7) |
Change from baseline in average daily rescue Ventolin HFA use
| Puffs / Day | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| Rescue Ventolin Hydrofluoroalkane (HFA) Use | -0.8 (-1.0 to -0.6) | -0.5 (-0.7 to -0.3) | -0.8 (-1.0 to -0.6) | -0.4 (-0.6 to -0.2) | 0.3 (0.0 to 0.6) |
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 | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| 5 min post dose | 0.185 (0.175 to 0.195) | 0.042 (0.031 to 0.053) | 0.182 (0.171 to 0.193) | 0.048 (0.037 to 0.059) | -0.002 (-0.017 to 0.014) |
| 15 min post dose | 0.226 (0.216 to 0.237) | 0.101 (0.090 to 0.113) | 0.212 (0.201 to 0.224) | 0.117 (0.105 to 0.129) | 0.022 (0.005 to 0.038) |
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
| Liters | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| Peak Change From Baseline in FEV1 Within 2 Hours Post-dose | 0.356 (0.335 to 0.377) | 0.223 (0.200 to 0.246) | 0.263 (0.240 to 0.285) | 0.259 (0.237 to 0.281) | 0.065 (0.031 to 0.098) |
Collected over SAEs and AEs were collected throughout study participation and for two weeks after study completion.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GFF MDI (PT003) | — | 44/526 (8.4%) | 73/526 (13.9%) |
| GP MDI (PT001) | — | 36/451 (8%) | 59/451 (13.1%) |
| FF MDI (PT005) | — | 29/452 (6.4%) | 57/452 (12.6%) |
| Spiriva® Handihaler® (Open-label) | — | 36/451 (8%) | 58/451 (12.9%) |
| Placebo | — | 16/220 (7.3%) | 47/220 (21.4%) |
| Event | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 15/526 | 17/451 | 8/452 | 8/451 | 7/220 |
| PneumoniaInfections and infestations | 8/526 | 7/451 | 0/452 | 1/451 | 1/220 |
| Chest painGeneral disorders | 1/526 | 2/451 | 1/452 | 0/451 | 2/220 |
| Squamous cell carcinoma of lungNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/526 | 0/451 | 0/452 | 3/451 | 0/220 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/526 | 0/451 | 0/452 | 0/451 | 1/220 |
| EpistatxisRespiratory, thoracic and mediastinal disorders | 0/526 | 0/451 | 0/452 | 0/451 | 1/220 |
| CellulitisInfections and infestations | 1/526 | 0/451 | 0/452 | 2/451 | 1/220 |
| PyelonephritisInfections and infestations | 0/526 | 0/451 | 0/452 | 0/451 | 1/220 |
| Coronary artery diseaseCardiac disorders | 1/526 | 1/451 | 0/452 | 1/451 | 1/220 |
| Acute myocardial infarctionCardiac disorders | 1/526 | 1/451 | 0/452 | 0/451 | 1/220 |
| Event | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 43/526 | 23/451 | 28/452 | 26/451 | 18/220 |
| Upper respiratory tract infectionInfections and infestations | 17/526 | 20/451 | 14/452 | 17/451 | 16/220 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 13/526 | 16/451 | 15/452 | 15/451 | 13/220 |
7 subjects were excluded from analysis.
| Age, Continuous(Years) | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 62.6 ± 8.4 | 62.9 ± 8.4 | 63.0 ± 8.3 | 63.0 ± 8.6 | 62.5 ± 8.3 | 62.8 ± 8.4 |
| Sex: Female, Male(Participants) | GFF MDI (PT003) | GP MDI (PT001) | FF MDI (PT005) | Spiriva® Handihaler® (Open-label) | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 236 | 196 | 203 | 182 | 97 | 914 |
| Male | 290 | 255 | 246 | 269 | 122 | 1182 |
Showing the first 100 of 140 sites across 3 countries.
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.