24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
18 de enero de 2018 actualizado por: GlaxoSmithKline
A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 and With Tiotropium Over 24 Weeks in Subjects With COPD
This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD).
Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period.
There will be a total of 9 clinic study visits.
A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal).
The total duration of subject participation in the study will be approximately 26 weeks.
The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169.
Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a 24-week, Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study.
Eligible subjects will be randomized to GSK573719/GW642444 125/25mcg, GSK573719/GW642444 62.5/25mcg, GW642444 25mcg, or tiotropium treatment groups in a 1:1:1:1 ratio.
Treatments will be administered once-daily in the morning by inhalation using a Novel Dry Powder Inhaler (Novel DPI) and HandiHaler.
There will be a total of 9 study clinic visits conducted on an outpatient basis.
Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7 to 10 day run-in period followed by a 24-week treatment period.
Clinic visits will be at Screening, Randomization (Day 1), Day 2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169).
A follow-up contact for adverse assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit.
The total duration of subject participation, including follow-up will be approximately 26 weeks.
All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and study treatment periods.
At screening, pre-bronchodilator spirometry testing will be followed by post-albuterol/salbutamol spirometry testing.
Post-albuterol/salbutamol FEV1 and FEV1/forced vital capacity (FVC) values will be used to determine subject eligibility.
To further characterize bronchodilator responsiveness, post-ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry.
Spirometry will be conducted at each post-randomization clinic visit.
Six hour post-dose serial spirometry will be conducted at Visits 2, 6, and 8. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 9. All subjects will be provided with an electronic diary (eDiary) for completion daily in the morning and the evening throughout the run-in and treatment periods.
Subjects will use the eDiary to record peak expiratory flow (PEF) each morning, dyspnea scores using the Shortness of Breath with Daily Activities instrument (SOBDA), daily use of supplemental albuterol/salbutamol as either puffs/day from a metered-dose inhaler (MDI) and/or nebules used per day, and any healthcare contacts related to COPD.
Additional assessments of dyspnea will be obtained using the Baseline and Transition Dyspnea Index (BDI/TDI) which is an interviewer based instrument.
At Visit 2, the severity of dyspnea at baseline will be assessed using the BDI.
At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI.
General health status will be evaluated using the subject-completed EQ-5D questionnaire at Visits 2, 4, 6, and 8. Disease specific health status will be evaluated using the subject-completed St. George's Respiratory Questionnaire (SGRQ) at Visits 2, 4, 6, and 8, and the subject-completed COPD Assessment Test (CAT) at Visits 2, 6, and 8.
The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs.
However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact.
Additional safety assessments of vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and chemistry) will be obtained at selected clinic visits.
Tipo de estudio
Intervencionista
Inscripción (Actual)
846
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 13086
- GSK Investigational Site
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Berlin, Alemania, 10717
- GSK Investigational Site
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Berlin, Alemania, 12203
- GSK Investigational Site
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Berlin, Alemania, 12157
- GSK Investigational Site
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Hamburg, Alemania, 22299
- GSK Investigational Site
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Baden-Wuerttemberg
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Sinsheim, Baden-Wuerttemberg, Alemania, 74889
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Alemania, 70378
- GSK Investigational Site
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Bayern
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Bamberg, Bayern, Alemania, 96049
- GSK Investigational Site
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Erlangen, Bayern, Alemania, 91052
- GSK Investigational Site
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Muenchen, Bayern, Alemania, 80339
- GSK Investigational Site
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Nuernberg, Bayern, Alemania, 90402
- GSK Investigational Site
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Brandenburg
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Potsdam, Brandenburg, Alemania, 14467
- GSK Investigational Site
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Hessen
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Marburg, Hessen, Alemania, 35037
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Alemania, 30159
- GSK Investigational Site
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Hannover, Niedersachsen, Alemania, 30173
- GSK Investigational Site
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Nordrhein-Westfalen
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Dortmund, Nordrhein-Westfalen, Alemania, 44263
- GSK Investigational Site
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Dortmund, Nordrhein-Westfalen, Alemania, 44147
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Estados Unidos, 35216
- GSK Investigational Site
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California
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San Diego, California, Estados Unidos, 92117
- GSK Investigational Site
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Florida
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DeLand, Florida, Estados Unidos, 32720
- GSK Investigational Site
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Orlando, Florida, Estados Unidos, 32822
- GSK Investigational Site
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Tampa, Florida, Estados Unidos, 33603
- GSK Investigational Site
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Georgia
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Decatur, Georgia, Estados Unidos, 30033
- GSK Investigational Site
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Missouri
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Saint Charles, Missouri, Estados Unidos, 63301
- GSK Investigational Site
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87108
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- GSK Investigational Site
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Pennsylvania
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Phoenixville, Pennsylvania, Estados Unidos, 19460
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29406-7108
- GSK Investigational Site
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Gaffney, South Carolina, Estados Unidos, 29340
- GSK Investigational Site
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Greenville, South Carolina, Estados Unidos, 29615
- GSK Investigational Site
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Rock Hill, South Carolina, Estados Unidos, 29732
- GSK Investigational Site
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Seneca, South Carolina, Estados Unidos, 29678
- GSK Investigational Site
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57702
- GSK Investigational Site
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- GSK Investigational Site
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Virginia
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Newport News, Virginia, Estados Unidos, 23606
- GSK Investigational Site
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Richmond, Virginia, Estados Unidos, 23229
- GSK Investigational Site
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Chita, Federación Rusa, 672000
- GSK Investigational Site
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Irkutsk, Federación Rusa, 664005
- GSK Investigational Site
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Moscow, Federación Rusa, 115446
- GSK Investigational Site
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Petrozavodsk, Federación Rusa, 185019
- GSK Investigational Site
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Ryazan, Federación Rusa, 390039
- GSK Investigational Site
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Saint-Petersburg, Federación Rusa, 194354
- GSK Investigational Site
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Saratov, Federación Rusa, 410028
- GSK Investigational Site
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Saratov, Federación Rusa, 410018
- GSK Investigational Site
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Tomsk, Federación Rusa, 634001
- GSK Investigational Site
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Voronezh, Federación Rusa, 394018
- GSK Investigational Site
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Yaroslavl, Federación Rusa
- GSK Investigational Site
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Clermont Ferrand cedex 1, Francia, 63003
- GSK Investigational Site
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Nantes cedex 1, Francia, 44093
- GSK Investigational Site
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Nîmes cedex 09, Francia, 30029
- GSK Investigational Site
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Saint Pierre Cedex, Francia, 97448
- GSK Investigational Site
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Campania
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Avellino, Campania, Italia, 83100
- GSK Investigational Site
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Friuli-Venezia-Giulia
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Pordenone, Friuli-Venezia-Giulia, Italia, 33170
- GSK Investigational Site
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Lazio
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Roma, Lazio, Italia, 00144
- GSK Investigational Site
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Liguria
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Pietra Ligure (SV), Liguria, Italia, 17027
- GSK Investigational Site
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Lombardia
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Milano, Lombardia, Italia, 20121
- GSK Investigational Site
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Pavia, Lombardia, Italia, 27100
- GSK Investigational Site
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Tradate (VA), Lombardia, Italia, 21049
- GSK Investigational Site
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Puglia
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Foggia, Puglia, Italia, 71100
- GSK Investigational Site
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Sicilia
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Catania, Sicilia, Italia, 95123
- GSK Investigational Site
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Toscana
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Pisa, Toscana, Italia, 56124
- GSK Investigational Site
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Mexico, México, 10700
- GSK Investigational Site
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Mexico City, México, 07760
- GSK Investigational Site
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Jalisco
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Guadalajara, Jalisco, México, 44100
- GSK Investigational Site
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Zapopan, Jalisco, México, 45200
- GSK Investigational Site
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Callao, Perú, Callao 2
- GSK Investigational Site
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Lima, Perú, Lima 1
- GSK Investigational Site
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Lima
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Jesus Maria, Lima, Perú, Lima 11
- GSK Investigational Site
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Lima 27, Lima, Perú, Lima 27
- GSK Investigational Site
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San Borja, Lima, Perú, Lima 41
- GSK Investigational Site
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San Isidro, Lima, Perú, Lima 27
- GSK Investigational Site
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San Miguel, Lima, Perú, Lima 32
- GSK Investigational Site
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Santiago de Surco, Lima, Perú, Lima 33
- GSK Investigational Site
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Gdansk, Polonia, 80-405
- GSK Investigational Site
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Gidle, Polonia, 97-540
- GSK Investigational Site
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Krakow, Polonia, 31-023
- GSK Investigational Site
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Lubliniec, Polonia, 42-700
- GSK Investigational Site
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Sopot, Polonia, 81-741
- GSK Investigational Site
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Wloclawek, Polonia, 87-800
- GSK Investigational Site
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Zabrze, Polonia, 41-800
- GSK Investigational Site
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Bacau, Rumania, 600252
- GSK Investigational Site
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Bucharest, Rumania, 011794
- GSK Investigational Site
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Ploiesti, Rumania, 100184
- GSK Investigational Site
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Timisoara, Rumania, 300310
- GSK Investigational Site
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Dnipropetrovsk, Ucrania, 49074
- GSK Investigational Site
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Dnipropetrovsk, Ucrania, 49027
- GSK Investigational Site
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Donetsk, Ucrania, 83099
- GSK Investigational Site
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Ivano-Frankivsk, Ucrania, 76018
- GSK Investigational Site
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Kharkiv, Ucrania, 61124
- GSK Investigational Site
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Kharkiv, Ucrania, 61037
- GSK Investigational Site
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Kiev, Ucrania, 03680
- GSK Investigational Site
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Kyiv, Ucrania, 03680
- GSK Investigational Site
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Kyiv, Ucrania, 03038
- GSK Investigational Site
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Kyiv, Ucrania, 01114
- GSK Investigational Site
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Simferopol, Ucrania, 95043
- GSK Investigational Site
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Vinnytsia, Ucrania, 21029
- GSK Investigational Site
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Zaporizhia, Ucrania, 69035
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- outpatient
- signed and dated written informed consent
- 40 years of age or older
- male and female subjects
- COPD diagnosis
- at least 10 pack-year smoking history
- post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of less than or equal to 70% predicted normal values
- score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)
Exclusion Criteria:
- women who are pregnant or lactating or are planning on becoming pregnant during the study
- current diagnosis of asthma
- other respiratory disorders other than COPD
- other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
- chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
- hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
- hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
- lung volume reduction surgery within 12 months prior to Visit 1
- abnormal and clinically significant ECG at Visit 1
- significantly abnormal finding from laboratory tests at Visit 1
- unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each visit
- use of depot corticosteroids within 12 weeks of Visit 1
- use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1
- use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1
- use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
- initiation or discontinuation of ICS within 30 days of Visit 1
- use of tiotropium or roflumilast within 14 days of Visit 1
- use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
- short-acting oral beta-agonists within 12 hours of Visit 1
- use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
- use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
- use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 4 hours of Visit 1
- use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
- long-term oxygen therapy prescribed for >12 hours per day
- regular use of nebulized short-acting bronchodilators
- participation in acute phase of pulmonary rehabilitation program
- known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
- anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
- previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: GSK573719/GW642444 125/25
125/25 mcg una vez al día
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125/25 mcg una vez al día
Otros nombres:
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Experimental: GSK573719/GW642444 62,5/25
62,5/25 mcg una vez al día
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62.5/26 mcg once-daily
Otros nombres:
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Comparador activo: bromuro de tiotropio
18 mcg una vez al día
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18 mcg una vez al día
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Experimental: GW642444
25 mcg once-daily
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25 mcg once-daily
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)
Periodo de tiempo: Baseline and Day 169
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169.
Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168).
Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline.
Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.
ITT=Intent-to-Treat; par.=participants. .
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Baseline and Day 169
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cambio desde el inicio (BL) en la media ponderada (WM) FEV1 de 0 a 6 horas obtenido después de la dosis en el día 168
Periodo de tiempo: Línea base y día 168
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FEV1 es una medida de la función pulmonar y se define como la cantidad máxima de aire que se puede exhalar con fuerza en un segundo.
El WM FEV1 se obtuvo calculando el área bajo la curva FEV1/tiempo (AUC) utilizando la regla trapezoidal y luego dividiendo el valor por el intervalo de tiempo durante el cual se calculó el AUC.
La WM se calculó en los días 1, 84 y 168 utilizando las mediciones de FEV1 de 0 a 6 horas posteriores a la dosis recopiladas ese día, que incluyeron la dosis previa (Día 1: 30 minutos [min] y 5 minutos antes de la dosificación ; otras visitas seriadas: 23 y 24 horas después de la dosis de la mañana anterior) y post-dosis a los 15 minutos, 30 minutos, 1 hora, 3 horas y 6 horas.
El cambio de BL en una visita en particular se calculó como WM en esa visita menos BL.
El análisis se realizó utilizando un modelo de medidas repetidas con covariables de tratamiento, BL (media de las dos evaluaciones realizadas 30 minutos y 5 minutos antes de la dosis el día 1), tabaquismo, grupo central, día y día por BL y día por tratamiento interacciones.
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Línea base y día 168
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cambio desde el inicio (BL) en la puntuación media de dificultad para respirar con actividades diarias (SOBDA) para la semana 24
Periodo de tiempo: Línea de base y semana 24
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El cuestionario SOBDA recientemente desarrollado evalúa la disnea o dificultad para respirar (SOB) con las actividades diarias.
El cuestionario SOBDA se compone de 13 elementos que completa el participante (par.) cada noche antes de acostarse, cuando el par. se le indica que reflexione sobre las actividades del día actual.
La puntuación diaria se calcula como la media de las puntuaciones de los 13 elementos (>=7 elementos deben tener respuestas que no falten para que se calcule).
El par. se le asigna una puntuación SOBDA media semanal que oscila entre 1 y 4 (las puntuaciones más altas indican una disnea más grave con las actividades diarias) en función de la media de 7 días de datos (>=4 de 7 días deben completarse para calcular una media semanal) .
El cambio de BL es la puntuación SOBDA semanal media menos BL.
El análisis se realizó mediante MMRM con covariables de tratamiento, BL (puntuación media en la semana anterior al tratamiento), tabaquismo, grupo central, semana, semanas por BL y semana por interacciones de tratamiento.
Este análisis MMRM solo incluyó las semanas 4, 8, 12 y 24.
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Línea de base y semana 24
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I. Assessing Short-term Deterioration in Maintenance-naive Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017 Jan;33(12):2188-2199. doi: 10.1007/s12325-016-0430-6. Epub 2016 Oct 28.
- Decramer M, Anzueto A, Kerwin E, Kaelin T, Richard N, Crater G, Tabberer M, Harris S, Church A. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014 Jun;2(6):472-86. doi: 10.1016/S2213-2600(14)70065-7. Epub 2014 May 14.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2011
Finalización primaria (Actual)
1 de abril de 2012
Finalización del estudio (Actual)
24 de abril de 2012
Fechas de registro del estudio
Enviado por primera vez
15 de marzo de 2011
Primero enviado que cumplió con los criterios de control de calidad
15 de marzo de 2011
Publicado por primera vez (Estimar)
16 de marzo de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de enero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de enero de 2018
Última verificación
1 de enero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades Pulmonares Obstructivas
- Enfermedades pulmonares
- Enfermedad Pulmonar Obstructiva Crónica
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Parasimpaticolíticos
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Antagonistas colinérgicos
- Agentes colinérgicos
- Anticonvulsivos
- Agentes broncodilatadores
- Agentes antiasmáticos
- Agentes del sistema respiratorio
- Bromuro de tiotropio
- Bromuros
Otros números de identificación del estudio
- 113360
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Plan de Análisis Estadístico
Identificador de información: 113360Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: 113360Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 113360Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 113360Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 113360Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 113360Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 113360Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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