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A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.
A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFF MDI (PT003) | Experimental | Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID) |
|
| FF MDI (PT005) | Experimental | Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID) |
|
| GP MDI (PT001) | Experimental | Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID) |
|
| Placebo MDI | Placebo Comparator | Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFF MDI (PT003) | Drug | Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach) | For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment | at week 24 |
| Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach | Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach | over weeks 12-24 |
| Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach. | Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach. | over 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach | TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner, MD | Pearl Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Andalusia | Alabama | 36420 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35815359 | Derived | Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314. | |
| 32450869 | Derived | Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y. |
| Label | URL |
|---|---|
| Updated cover page | View source |
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AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.
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Subjects were randomized in a 7:6:6:3 scheme (GFF MDI, FF MDI, GP MDI, and Placebo MDI). Randomization was stratified by reversibility to Ventolin HFA and COPD disease severity (moderate vs severe or very severe) to ensure a similar distribution of treatment arms across stratum.
The study was conducted at 175 sites in the United States, United Kingdom, Taiwan (TW),South Korea (SK), Russia, Poland, Hungary, Germany, Czech Republic, China, and Japan from April 2015 to August 2017. The entire study period was scheduled to take approximately 30 weeks for each individual subject from the time of screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | GFF MDI 14.4/9.6 ug | Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug |
| FG001 | FF MDI 9.6 ug | Formoterol Fumarate, Metered Dose Inhalation 9.6 ug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2017 | Jan 28, 2019 |
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|
| FF MDI (PT005) | Drug | Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID) |
|
|
| GP MDI (PT001) | Drug | Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID) |
|
|
| Placebo MDI | Drug | Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID) |
|
|
| over 24 Weeks |
| TDI Focal Score Over Weeks 12-24 Japan Approach | TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 | over Weeks 12-24 |
| TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population | TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 | over 24 Weeks |
| TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population | TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 | over weeks 12-24 |
| Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach | Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach | at week 24 |
| Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach | Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach | over weeks 12-24 |
| Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach | Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach | over 24 weeks |
| Change From Baseline in SGRQ Total Score at Week 24, US/China Approach | 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 | at week 24 |
| Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach | 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 | over weeks 12-24 |
| Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach | 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 | at week 24 |
| Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach | 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 | over weeks 12-24 |
| Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches | Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches | over 24 weeks |
| FEV1 Measured at 5 Minutes Post-dose on Day 1 | Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant | Assessed at 5-minutes post dose on Day 1 |
| FEV1 Measured at 15 Minutes Post-dose on Day 1 | Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant | Assessed at 15-minute post dose on Day 1 |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Research Site | Foley | Alabama | 36535 | United States |
| Research Site | Jasper | Alabama | 35501 | United States |
| Research Site | Anaheim | California | 92801 | United States |
| Research Site | Boulder | Colorado | 80301 | United States |
| Research Site | Clearwater | Florida | 33756 | United States |
| Research Site | Clearwater | Florida | 33765 | United States |
| Research Site | Kissimmee | Florida | 34744 | United States |
| Research Site | Miami | Florida | 33175 | United States |
| Research Site | Miami | Florida | 33186 | United States |
| Research Site | Panama City | Florida | 32405 | United States |
| Research Site | Pensacola | Florida | 32503 | United States |
| Research Site | Tamarac | Florida | 33321 | United States |
| Research Site | Tampa | Florida | 33603 | United States |
| Research Site | Winter Park | Florida | 32789-4681 | United States |
| Research Site | Atlanta | Georgia | 30331 | United States |
| Research Site | Blue Ridge | Georgia | 30513 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Site | Edina | Minnesota | 55435 | United States |
| Research Site | Fridley | Minnesota | 55432 | United States |
| Research Site | Minneapolis | Minnesota | 55407 | United States |
| Research Site | Woodbury | Minnesota | 55125 | United States |
| Research Site | Saint Charles | Missouri | 63301 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Gastonia | North Carolina | 28054 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Columbus | Ohio | 43215 | United States |
| Research Site | Columbus | Ohio | 43231 | United States |
| Research Site | Dayton | Ohio | 45419 | United States |
| Research Site | Dayton | Ohio | 45459 | United States |
| Research Site | Dublin | Ohio | 43016 | United States |
| Research Site | Oklahoma City | Oklahoma | 73103 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Easley | South Carolina | 29640 | United States |
| Research Site | Gaffney | South Carolina | 29341 | United States |
| Research Site | Greenville | South Carolina | 29615 | United States |
| Research Site | Rock Hill | South Carolina | 29732 | United States |
| Research Site | Seneca | South Carolina | 29678 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Union | South Carolina | 29379 | United States |
| Research Site | Johnson City | Tennessee | 37601 | United States |
| Research Site | Abingdon | Virginia | 24210 | United States |
| Research Site | Beijing | 100029 | China |
| Research Site | Beijing | 100050 | China |
| Research Site | Beijing | 100144 | China |
| Research Site | Changchun | 130021 | China |
| Research Site | Changsha | 410011 | China |
| Research Site | Chengdu | 610083 | China |
| Research Site | Chengdu | CN-610041 | China |
| Research Site | Guangzhou | 510000 | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Guangzhou | 510515 | China |
| Research Site | Guiyang | 510630 | China |
| Research Site | Haikou | 570311 | China |
| Research Site | Hefei | 230001 | China |
| Research Site | Heshan | 413000 | China |
| Research Site | Hohhot | 010017 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Nanning | 530021 | China |
| Research Site | Shanghai | 200040 | China |
| Research Site | Shanghai | 200120 | China |
| Research Site | Shanghai | 200433 | China |
| Research Site | Shengyang | 110004 | China |
| Research Site | Shenyang | 110016 | China |
| Research Site | Shijiazhuang | 050000 | China |
| Research Site | Shijiazhuang | 050051 | China |
| Research Site | Suzhou | 215006 | China |
| Research Site | Taiyuan | 030001 | China |
| Research Site | Tianjin | 300052 | China |
| Research Site | Wuxi | 214023 | China |
| Research Site | Xiamen | 361004 | China |
| Research Site | Xining | 810007 | China |
| Research Site | Jindřichův Hradec | 37701 | Czechia |
| Research Site | Ostrava-Hrabuvka | 700 30 | Czechia |
| Research Site | Prague | 15000 | Czechia |
| Research Site | Teplice | 415 01 | Czechia |
| Research Site | Augsburg | 86150 | Germany |
| Research Site | Berlin | 10629 | Germany |
| Research Site | Berlin | 10787 | Germany |
| Research Site | Berlin | 12157 | Germany |
| Research Site | Grosshansdof | 22927 | Germany |
| Research Site | Hamburg | 20354 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Leipzig | 04357 | Germany |
| Research Site | Lübeck | 23552 | Germany |
| Research Site | Wiesbaden | 65187 | Germany |
| Research Site | Budapest | 1135 | Hungary |
| Research Site | Gödöllő | 2100 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Pécs | 7635 | Hungary |
| Research Site | Siófok | 8600 | Hungary |
| Research Site | Szeged | H-6722 | Hungary |
| Research Site | Ako-shi | 678-0239 | Japan |
| Research Site | Asahikawa-shi | 070-8644 | Japan |
| Research Site | Chūōku | 103-0027 | Japan |
| Research Site | Chūōku | 103-0028 | Japan |
| Research Site | Fukuoka | 811-1394 | Japan |
| Research Site | Hamamatsu | 434-8511 | Japan |
| Research Site | Himeji-shi | 671-0102 | Japan |
| Research Site | Himeji-shi | 672-8064 | Japan |
| Research Site | Hitachi-Naka | 312-0057 | Japan |
| Research Site | Itabashi-ku | 173-8610 | Japan |
| Research Site | Kakogawa-shi | 675-0023 | Japan |
| Research Site | Kamogawa-shi | 296-0041 | Japan |
| Research Site | Kanazawa | 920-8201 | Japan |
| Research Site | Kishiwada-shi | 596-8501 | Japan |
| Research Site | Kobe | 650-0047 | Japan |
| Research Site | Koga-shi | 811-3195 | Japan |
| Research Site | Matsumoto-shi | 390-0872 | Japan |
| Research Site | Matsumoto-shi | 390-8621 | Japan |
| Research Site | Mito | 310-0015 | Japan |
| Research Site | Nagaoka-shi | 940-2085 | Japan |
| Research Site | Nagoya | 457-0866 | Japan |
| Research Site | Naka-gun | 319-1113 | Japan |
| Research Site | Ohota-ku | 145-0063 | Japan |
| Research Site | Ōita | 870-0951 | Japan |
| Research Site | Saiki-shi | 876-0813 | Japan |
| Research Site | Sendai | 981-8563 | Japan |
| Research Site | Sendai | 983-0824 | Japan |
| Research Site | Seto-shi | 489-8642 | Japan |
| Research Site | Shimotsuga-gun | 321-0293 | Japan |
| Research Site | Takamatsu | 760-8538 | Japan |
| Research Site | Toon-shi | 791-0281 | Japan |
| Research Site | Yanagawa-shi | 832-0059 | Japan |
| Research Site | Yokohama | 232-0066 | Japan |
| Research Site | Yokohama | 241-0811 | Japan |
| Research Site | Bialystok | 15-003 | Poland |
| Research Site | Bialystok | 15-044 | Poland |
| Research Site | Elblag | 82-300 | Poland |
| Research Site | Inowrocław | 88-100 | Poland |
| Research Site | Lodz | 90-153 | Poland |
| Research Site | Lodz | 90-203 | Poland |
| Research Site | Piekary Śląskie | 41-94O | Poland |
| Research Site | Rzeszów | 35-205 | Poland |
| Research Site | Skierniewice | 96-100 | Poland |
| Research Site | Szczecin | 70-111 | Poland |
| Research Site | Tarnów | 33-100 | Poland |
| Research Site | Torun | 87-100 | Poland |
| Research Site | Warszawa Targowek | 03-291 | Poland |
| Research Site | Gatchina | 188300 | Russia |
| Research Site | Moscow | 105229 | Russia |
| Research Site | Moscow | 127018 | Russia |
| Research Site | Pytigorsk | 357538 | Russia |
| Research Site | Saint Petersburg | 195271 | Russia |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Saint Petersburg | 198260 | Russia |
| Research Site | Busan | 602-715 | South Korea |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Seoul | 04551 | South Korea |
| Research Site | Seoul | 130-709 | South Korea |
| Research Site | Seoul | 130-872 | South Korea |
| Research Site | Seoul | 136-705 | South Korea |
| Research Site | Seoul | 152-703 | South Korea |
| Research Site | Wŏnju | 220-701 | South Korea |
| Research Site | Kaohsiung City | 83301 | Taiwan |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Dundee | DD1 9SY | United Kingdom |
| Research Site | London | EC1M 6BQ | United Kingdom |
| Research Site | London | W1G 8HU | United Kingdom |
| Research Site | Northwood | HA6 2RN | United Kingdom |
| Research Site | Sidcup | DA14 6LT | United Kingdom |
| 32021148 | Derived | Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020. |
| 32021143 | Derived | Chen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020. |
| Updated Cover page | View source |
| Updated Cover page | View source |
| Updated cover page | View source |
| FG002 | GP MDI 14.4 ug | Glycopyrronium 14.4 ug Metered Dose Inhalation |
| FG003 | Placebo MDI | Placebo Metered Dose Inhalation |
| COMPLETED | 1 subject has been captured in CSR who completed the study but had no follow up phone call. |
|
| NOT COMPLETED |
|
|
The data reported from one site was not included in the final analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GFF MDI 14.4/9.6 ug | Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug |
| BG001 | FF MDI 9.6 ug | Formoterol Fumarate, Metered Dose Inhalation 9.6 ug |
| BG002 | GP MDI 14.4 ug | Glycopyrronium 14.4 ug Metered Dose Inhalation |
| BG003 | Placebo MDI | Placebo Metered Dose Inhalation |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | ITT Population | Mean | Standard Deviation | Years |
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| Sex: Female, Male | The data reported from one site was not included in the final analysis | Count of Participants | Participants |
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| Race (NIH/OMB) | ITT Population | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach) | For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | mL | at week 24 |
|
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| Primary | Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach | Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | mL | over weeks 12-24 |
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| Primary | Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach. | Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach. | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | mL | over 24 weeks |
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| Secondary | TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach | TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | over 24 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | TDI Focal Score Over Weeks 12-24 Japan Approach | TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | over Weeks 12-24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population | TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 | Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2 | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | over 24 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population | TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9 | Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2 | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | over weeks 12-24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach | Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | mL | at week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach | Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | mL | over weeks 12-24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach | Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | mL | over 24 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SGRQ Total Score at Week 24, US/China Approach | 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 | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | at week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach | 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 | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | over weeks 12-24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach | 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 | Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2n | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | at week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach | 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 | Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2 | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | over weeks 12-24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches | Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches | RVU Population - defined as Rescue Ventolin User | Posted | Least Squares Mean | 95% Confidence Interval | Puffs/day | over 24 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | FEV1 Measured at 5 Minutes Post-dose on Day 1 | Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Assessed at 5-minutes post dose on Day 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 Measured at 15 Minutes Post-dose on Day 1 | Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant | ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Assessed at 15-minute post dose on Day 1 |
|
Adverse events were collected from the time the subject signed consent throughout the four treatment periods of 24 weeks and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GFF MDI 14.4/9.6 ug | Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug | 1 | 551 | 53 | 551 | 166 | 551 |
| EG001 | FF MDI 9.6 ug | Formoterol Fumarate, Metered Dose Inhalation 9.6 ug | 1 | 480 | 40 | 480 | 123 | 480 |
| EG002 | GP MDI 14.4 ug | Glycopyrronium 14.4 ug Metered Dose Inhalation | 1 | 474 | 34 | 474 | 128 | 474 |
| EG003 | Placebo MDI | Placebo Metered Dose Inhalation | 1 | 235 | 19 | 235 | 61 | 235 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Borrelia Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis ischemic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorroids thrombosed | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cardiac myxoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Haemangiopericytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Humerous fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycemic coma | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pseudoradicular syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Diabetes melitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Angel closure glaucoma | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Somatic symptom disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pearl Therapeutics Inc. | Pearl Therapeutics Inc. | 650-305-2600 | creisner@pearltherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2017 | Jan 28, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
Placebo Metered Dose Inhalation
|
|
| OG003 | Placebo MDI | Placebo Metered Dose Inhalation |
|
|
| OG003 |
| Placebo MDI |
Placebo Metered Dose Inhalation |
|
|
Placebo Metered Dose Inhalation
|
|
Placebo Metered Dose Inhalation
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| GP MDI 14.4 ug |
Glycopyrronium 14.4 ug Metered Dose Inhalation |
| OG003 | Placebo MDI | Placebo Metered Dose Inhalation |
|
|
| OG002 |
| GP MDI 14.4 ug |
Glycopyrronium 14.4 ug Metered Dose Inhalation |
| OG003 | Placebo MDI | Placebo Metered Dose Inhalation |
|
|
Glycopyrronium 14.4 ug Metered Dose Inhalation
| OG003 | Placebo MDI | Placebo Metered Dose Inhalation |
|
|
Glycopyrronium 14.4 ug Metered Dose Inhalation
| OG003 | Placebo MDI | Placebo Metered Dose Inhalation |
|
|
| Participants |
|
|
Placebo Metered Dose Inhalation
|
|
Placebo Metered Dose Inhalation
|
|