24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
18 januari 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
846
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Clermont Ferrand cedex 1, Frankrike, 63003
- GSK Investigational Site
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Nantes cedex 1, Frankrike, 44093
- GSK Investigational Site
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Nîmes cedex 09, Frankrike, 30029
- GSK Investigational Site
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Saint Pierre Cedex, Frankrike, 97448
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Förenta staterna, 35216
- GSK Investigational Site
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California
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San Diego, California, Förenta staterna, 92117
- GSK Investigational Site
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Florida
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DeLand, Florida, Förenta staterna, 32720
- GSK Investigational Site
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Orlando, Florida, Förenta staterna, 32822
- GSK Investigational Site
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Tampa, Florida, Förenta staterna, 33603
- GSK Investigational Site
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Georgia
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Decatur, Georgia, Förenta staterna, 30033
- GSK Investigational Site
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Missouri
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Saint Charles, Missouri, Förenta staterna, 63301
- GSK Investigational Site
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87108
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73103
- GSK Investigational Site
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Pennsylvania
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Phoenixville, Pennsylvania, Förenta staterna, 19460
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29406-7108
- GSK Investigational Site
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Gaffney, South Carolina, Förenta staterna, 29340
- GSK Investigational Site
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Greenville, South Carolina, Förenta staterna, 29615
- GSK Investigational Site
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Rock Hill, South Carolina, Förenta staterna, 29732
- GSK Investigational Site
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Seneca, South Carolina, Förenta staterna, 29678
- GSK Investigational Site
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57702
- GSK Investigational Site
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Texas
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San Antonio, Texas, Förenta staterna, 78229
- GSK Investigational Site
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Virginia
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Newport News, Virginia, Förenta staterna, 23606
- GSK Investigational Site
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Richmond, Virginia, Förenta staterna, 23229
- GSK Investigational Site
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Campania
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Avellino, Campania, Italien, 83100
- GSK Investigational Site
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Friuli-Venezia-Giulia
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Pordenone, Friuli-Venezia-Giulia, Italien, 33170
- GSK Investigational Site
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Lazio
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Roma, Lazio, Italien, 00144
- GSK Investigational Site
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Liguria
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Pietra Ligure (SV), Liguria, Italien, 17027
- GSK Investigational Site
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Lombardia
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Milano, Lombardia, Italien, 20121
- GSK Investigational Site
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Pavia, Lombardia, Italien, 27100
- GSK Investigational Site
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Tradate (VA), Lombardia, Italien, 21049
- GSK Investigational Site
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Puglia
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Foggia, Puglia, Italien, 71100
- GSK Investigational Site
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Sicilia
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Catania, Sicilia, Italien, 95123
- GSK Investigational Site
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Toscana
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Pisa, Toscana, Italien, 56124
- GSK Investigational Site
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Mexico, Mexiko, 10700
- GSK Investigational Site
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Mexico City, Mexiko, 07760
- GSK Investigational Site
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44100
- GSK Investigational Site
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Zapopan, Jalisco, Mexiko, 45200
- GSK Investigational Site
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Callao, Peru, Callao 2
- GSK Investigational Site
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Lima, Peru, Lima 1
- GSK Investigational Site
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Lima
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Jesus Maria, Lima, Peru, Lima 11
- GSK Investigational Site
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Lima 27, Lima, Peru, Lima 27
- GSK Investigational Site
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San Borja, Lima, Peru, Lima 41
- GSK Investigational Site
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San Isidro, Lima, Peru, Lima 27
- GSK Investigational Site
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San Miguel, Lima, Peru, Lima 32
- GSK Investigational Site
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Santiago de Surco, Lima, Peru, Lima 33
- GSK Investigational Site
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Gdansk, Polen, 80-405
- GSK Investigational Site
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Gidle, Polen, 97-540
- GSK Investigational Site
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Krakow, Polen, 31-023
- GSK Investigational Site
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Lubliniec, Polen, 42-700
- GSK Investigational Site
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Sopot, Polen, 81-741
- GSK Investigational Site
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Wloclawek, Polen, 87-800
- GSK Investigational Site
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Zabrze, Polen, 41-800
- GSK Investigational Site
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Bacau, Rumänien, 600252
- GSK Investigational Site
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Bucharest, Rumänien, 011794
- GSK Investigational Site
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Ploiesti, Rumänien, 100184
- GSK Investigational Site
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Timisoara, Rumänien, 300310
- GSK Investigational Site
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Chita, Ryska Federationen, 672000
- GSK Investigational Site
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Irkutsk, Ryska Federationen, 664005
- GSK Investigational Site
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Moscow, Ryska Federationen, 115446
- GSK Investigational Site
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Petrozavodsk, Ryska Federationen, 185019
- GSK Investigational Site
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Ryazan, Ryska Federationen, 390039
- GSK Investigational Site
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Saint-Petersburg, Ryska Federationen, 194354
- GSK Investigational Site
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Saratov, Ryska Federationen, 410028
- GSK Investigational Site
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Saratov, Ryska Federationen, 410018
- GSK Investigational Site
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Tomsk, Ryska Federationen, 634001
- GSK Investigational Site
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Voronezh, Ryska Federationen, 394018
- GSK Investigational Site
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Yaroslavl, Ryska Federationen
- GSK Investigational Site
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Berlin, Tyskland, 13086
- GSK Investigational Site
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Berlin, Tyskland, 10717
- GSK Investigational Site
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Berlin, Tyskland, 12203
- GSK Investigational Site
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Berlin, Tyskland, 12157
- GSK Investigational Site
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Hamburg, Tyskland, 22299
- GSK Investigational Site
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Baden-Wuerttemberg
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Sinsheim, Baden-Wuerttemberg, Tyskland, 74889
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Tyskland, 70378
- GSK Investigational Site
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Bayern
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Bamberg, Bayern, Tyskland, 96049
- GSK Investigational Site
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Erlangen, Bayern, Tyskland, 91052
- GSK Investigational Site
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Muenchen, Bayern, Tyskland, 80339
- GSK Investigational Site
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Nuernberg, Bayern, Tyskland, 90402
- GSK Investigational Site
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Brandenburg
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Potsdam, Brandenburg, Tyskland, 14467
- GSK Investigational Site
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Hessen
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Marburg, Hessen, Tyskland, 35037
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Tyskland, 30159
- GSK Investigational Site
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Hannover, Niedersachsen, Tyskland, 30173
- GSK Investigational Site
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Nordrhein-Westfalen
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Dortmund, Nordrhein-Westfalen, Tyskland, 44263
- GSK Investigational Site
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Dortmund, Nordrhein-Westfalen, Tyskland, 44147
- GSK Investigational Site
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Dnipropetrovsk, Ukraina, 49074
- GSK Investigational Site
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Dnipropetrovsk, Ukraina, 49027
- GSK Investigational Site
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Donetsk, Ukraina, 83099
- GSK Investigational Site
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Ivano-Frankivsk, Ukraina, 76018
- GSK Investigational Site
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Kharkiv, Ukraina, 61124
- GSK Investigational Site
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Kharkiv, Ukraina, 61037
- GSK Investigational Site
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Kiev, Ukraina, 03680
- GSK Investigational Site
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Kyiv, Ukraina, 03680
- GSK Investigational Site
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Kyiv, Ukraina, 03038
- GSK Investigational Site
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Kyiv, Ukraina, 01114
- GSK Investigational Site
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Simferopol, Ukraina, 95043
- GSK Investigational Site
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Vinnytsia, Ukraina, 21029
- GSK Investigational Site
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Zaporizhia, Ukraina, 69035
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: GSK573719/GW642444 125/25
125/25 mcg en gång dagligen
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125/25 mcg en gång dagligen
Andra namn:
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Experimentell: GSK573719/GW642444 62,5/25
62,5/25 mcg en gång dagligen
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62.5/26 mcg once-daily
Andra namn:
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Aktiv komparator: tiotropiumbromid
18 mcg en gång dagligen
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18 mcg en gång dagligen
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Experimentell: GW642444
25 mcg once-daily
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25 mcg once-daily
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Ändring från baslinje (BL) i vägt medelvärde (WM) 0-6 timmar FEV1 Erhållen efter dos på dag 168
Tidsram: Baslinje och dag 168
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FEV1 är ett mått på lungfunktion och definieras som den maximala mängd luft som kan andas ut med kraft på en sekund.
WM FEV1 härleddes genom att beräkna arean under FEV1/tidskurvan (AUC) med användning av trapetsregeln och sedan dividera värdet med tidsintervallet över vilket AUC beräknades.
WM beräknades vid dag 1, 84 och dag 168 med hjälp av FEV1-mätningarna 0-6 timmar efter dos som samlades in den dagen, vilket inkluderade före dosering (dag 1: 30 minuter [min] och 5 minuter före dosering andra seriebesök: 23 och 24 timmar efter föregående morgondos) och efter dosering 15 minuter, 30 minuter, 1 timme, 3 timmar och 6 timmar.
Förändring från BL vid ett visst besök beräknades som WM vid det besöket minus BL.
Analysen utfördes med användning av en modell med upprepade mätningar med kovariater av behandling, BL (medelvärde av de två bedömningarna gjorda 30 minuter och 5 minuter före dos på dag 1), rökstatus, centergrupp, dag och dag för BL och dag för behandling interaktioner.
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Baslinje och dag 168
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Förändring från baslinjen (BL) i genomsnittlig andnöd med dagliga aktiviteter (SOBDA) poäng för vecka 24
Tidsram: Baslinje och vecka 24
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Det nyutvecklade SOBDA-enkätet bedömer dyspné eller andnöd (SOB) med dagliga aktiviteter.
SOBDA-frågeformuläret består av 13 uppgifter som fylls i av deltagaren (par.) varje kväll före läggdags, när par. får i uppdrag att reflektera över dagens aktiviteter.
Den dagliga poängen beräknas som medelvärdet av poängen på de 13 punkterna (>=7 poster måste ha icke-saknade svar för att detta ska kunna beräknas).
Par. tilldelas ett veckomedelvärde för SOBDA som sträcker sig från 1 till 4 (högre poäng indikerar svårare andfåddhet vid dagliga aktiviteter) baserat på medelvärdet av 7 dagars data (>=4 av 7 dagar måste fyllas i för att ett veckomedelvärde ska kunna beräknas) .
Ändring från BL är den genomsnittliga veckovisa SOBDA-poängen minus BL.
Analys utfördes med användning av MMRM med kovariater av behandling, BL (medelpoäng veckan före behandling), rökstatus, centergrupp, vecka, vecka för BL och vecka för behandlingsinteraktioner.
Denna MMRM-analys inkluderade endast veckorna 4, 8, 12 och 24.
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Baslinje och vecka 24
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2011
Primärt slutförande (Faktisk)
1 april 2012
Avslutad studie (Faktisk)
24 april 2012
Studieregistreringsdatum
Först inskickad
15 mars 2011
Först inskickad som uppfyllde QC-kriterierna
15 mars 2011
Första postat (Uppskatta)
16 mars 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 januari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdomar
- Lungsjukdom, kronisk obstruktiv
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Parasympatholytika
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Kolinerga antagonister
- Kolinerga medel
- Antikonvulsiva medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Tiotropiumbromid
- Bromider
Andra studie-ID-nummer
- 113360
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Statistisk analysplan
Informationsidentifierare: 113360Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 113360Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 113360Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoterad fallrapportformulär
Informationsidentifierare: 113360Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: 113360Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Informerat samtycke
Informationsidentifierare: 113360Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 113360Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .