- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147744
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
September 28, 2017 updated by: GlaxoSmithKline
A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twice Daily and Montelukast 10mg Once Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma While Treated With Short Acting Beta2-agonist.
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma.
These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies.
The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Drug: GSK2190915 10mg
- Drug: Placebo GSK2190915 one tablet
- Drug: Placebo montelukast
- Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS
- Drug: GSK2190915 30mg
- Drug: GSK2190915 100mg
- Drug: GSK2190915 300mg
- Drug: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS
- Drug: Placebo GSK2190915 two tablets
- Drug: Montelukast 10mg
Study Type
Interventional
Enrollment (Actual)
700
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pleven, Bulgaria, 5800
- GSK Investigational Site
-
Plovdiv, Bulgaria, 4003
- GSK Investigational Site
-
Ruse, Bulgaria, 7000
- GSK Investigational Site
-
Sofia, Bulgaria, 1431
- GSK Investigational Site
-
Sofia, Bulgaria, 1407
- GSK Investigational Site
-
Sofia, Bulgaria, 1000
- GSK Investigational Site
-
Sofia, Bulgaria, 1202
- GSK Investigational Site
-
Stara Zagora, Bulgaria, 6000
- GSK Investigational Site
-
Varna, Bulgaria, 9010
- GSK Investigational Site
-
-
-
-
-
Chiba, Japan, 292-0805
- GSK Investigational Site
-
Fukuoka, Japan, 819-1102
- GSK Investigational Site
-
Fukuoka, Japan, 819-0006
- GSK Investigational Site
-
Hokkaido, Japan, 062-0034
- GSK Investigational Site
-
Hokkaido, Japan, 064-0801
- GSK Investigational Site
-
Ibaraki, Japan, 319-1113
- GSK Investigational Site
-
Kanagawa, Japan, 210-0852
- GSK Investigational Site
-
Osaka, Japan, 530-0001
- GSK Investigational Site
-
Osaka, Japan, 565-0853
- GSK Investigational Site
-
Saitama, Japan, 343-0851
- GSK Investigational Site
-
Tokyo, Japan, 102-0083
- GSK Investigational Site
-
Tokyo, Japan, 103-0027
- GSK Investigational Site
-
Tokyo, Japan, 103-0028
- GSK Investigational Site
-
Tokyo, Japan, 153-0051
- GSK Investigational Site
-
Tokyo, Japan, 154-0024
- GSK Investigational Site
-
Tokyo, Japan, 171-0014
- GSK Investigational Site
-
Tokyo, Japan, 158-0097
- GSK Investigational Site
-
Tokyo, Japan, 190-0013
- GSK Investigational Site
-
Tokyo, Japan, 130-8587
- GSK Investigational Site
-
-
-
-
-
Bialystok, Poland, 15-084
- GSK Investigational Site
-
Katowice, Poland, 40-018
- GSK Investigational Site
-
Krakow, Poland, 31-024
- GSK Investigational Site
-
Libiaz, Poland, 32-590
- GSK Investigational Site
-
Lodz, Poland, 93-329
- GSK Investigational Site
-
Poznan, Poland, 60-693
- GSK Investigational Site
-
Tarnow, Poland, 33-100
- GSK Investigational Site
-
-
-
-
-
Brasov, Romania, 500112
- GSK Investigational Site
-
Bucharest, Romania, 050159
- GSK Investigational Site
-
Bucharest, Romania, 020125
- GSK Investigational Site
-
Bucharest, Romania, 022102
- GSK Investigational Site
-
Cluj-Napoca, Romania, 400371
- GSK Investigational Site
-
Cluj-Napoca, Romania, 400217
- GSK Investigational Site
-
Deva, Romania, 330084
- GSK Investigational Site
-
Timisoara, Romania, 300310
- GSK Investigational Site
-
-
-
-
-
Dnipropetrovsk, Ukraine, 49006
- GSK Investigational Site
-
Dnipropetrovsk, Ukraine, 49051
- GSK Investigational Site
-
Dnipropetrovsk, Ukraine, 49027
- GSK Investigational Site
-
Donetsk, Ukraine, 83099
- GSK Investigational Site
-
Ivano-Frankivsk, Ukraine, 76018
- GSK Investigational Site
-
Kharkiv, Ukraine, 61124
- GSK Investigational Site
-
Kharkiv, Ukraine, 61037
- GSK Investigational Site
-
Kharkiv, Ukraine, 61002
- GSK Investigational Site
-
Kiev, Ukraine, 03680
- GSK Investigational Site
-
Kyiv, Ukraine
- GSK Investigational Site
-
Kyiv, Ukraine, 02232
- GSK Investigational Site
-
Kyiv, Ukraine, 03680
- GSK Investigational Site
-
Kyiv, Ukraine, 03115
- GSK Investigational Site
-
Kyiv, Ukraine, 04201
- GSK Investigational Site
-
Kyiv, Ukraine, 04107
- GSK Investigational Site
-
Odesa, Ukraine, 65114
- GSK Investigational Site
-
Simferopol, Ukraine, 95043
- GSK Investigational Site
-
Yalta, Ukraine, 98603
- GSK Investigational Site
-
Zaporizhia, Ukraine, 69035
- GSK Investigational Site
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- GSK Investigational Site
-
-
California
-
Huntington Beach, California, United States, 92647
- GSK Investigational Site
-
Newport Beach, California, United States, 92663
- GSK Investigational Site
-
San Diego, California, United States, 92123
- GSK Investigational Site
-
-
Florida
-
Tallahassee, Florida, United States, 32308
- GSK Investigational Site
-
-
Kentucky
-
Owensboro, Kentucky, United States, 42301
- GSK Investigational Site
-
-
Louisiana
-
Metairie, Louisiana, United States, 70006
- GSK Investigational Site
-
-
Maine
-
Bangor, Maine, United States, 04401
- GSK Investigational Site
-
-
Michigan
-
Ypsilanti, Michigan, United States, 48197
- GSK Investigational Site
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55402
- GSK Investigational Site
-
-
Missouri
-
Columbia, Missouri, United States, 65203
- GSK Investigational Site
-
Rolla, Missouri, United States, 65401
- GSK Investigational Site
-
Saint Louis, Missouri, United States, 63141
- GSK Investigational Site
-
-
New Jersey
-
Ocean City, New Jersey, United States, 07712
- GSK Investigational Site
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27607
- GSK Investigational Site
-
-
Ohio
-
Canton, Ohio, United States, 44718
- GSK Investigational Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73103
- GSK Investigational Site
-
-
Oregon
-
Medford, Oregon, United States, 97504
- GSK Investigational Site
-
-
South Carolina
-
Orangeburg, South Carolina, United States, 29118
- GSK Investigational Site
-
-
Texas
-
San Antonio, Texas, United States, 78229
- GSK Investigational Site
-
Waco, Texas, United States, 76712
- GSK Investigational Site
-
-
Washington
-
Bellingham, Washington, United States, 98225
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Type of Subject: Outpatient
- Age: ≥12 years of age
- Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
- Asthma Diagnosis: As defined by NIH
- Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio >0.70
- Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
- Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
- Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
- QTC: QTc(F)<450msec or QTc(F)<480 for subjects with Bundle Branch Block
- Liver function: Normal liver function
- Informed Consent
Exclusion Criteria:
- History of Life-threatening asthma: Within previous 5 years
- Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
- Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
- Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
- OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks
- Immunosuppressive medications: Either using or required during the study
- Liver disease: Current or chronic history
- Concurrent disease/abnormalities: Clinically significant uncontrolled disease
- Investigational medications: Participation in a study or used investigational drug within 30 days
- Drug allergy: β-agonists, corticosteroids, constituents of inhalers
- Milk Protein Allergy: History of severe milk protein allergy
- Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance
- Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs
- History of alcohol or drug abuse: Likely to interfere with the study
- Affiliation with Investigator's Site: Relative or employee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GSK2190915 10mg and placebo
GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
|
GSK2190915 10mg (1 x 10mg) once daily in the morning
Placebo tablet, one tablet once daily in the morning
Placebo capsule once daily in the evening
Inhaled placebo twice daily via ACCUHALER/DISKUS
|
Experimental: GSK2190915 30mg and placebo
GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
|
Placebo tablet, one tablet once daily in the morning
Placebo capsule once daily in the evening
Inhaled placebo twice daily via ACCUHALER/DISKUS
GSK2190915 30mg (1 x 30mg) once daily in the morning
|
Experimental: GSK2190915 100mg QD and placebo
GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
|
Placebo tablet, one tablet once daily in the morning
Placebo capsule once daily in the evening
Inhaled placebo twice daily via ACCUHALER/DISKUS
GSK2190915 100mg (1 x 100mg) once daily in the morning
|
Experimental: GSK2190915 300mg QD and placebo
GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
|
Placebo capsule once daily in the evening
Inhaled placebo twice daily via ACCUHALER/DISKUS
GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning
|
Active Comparator: Fluticasone propionate 100mcg and placebo
Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening
|
Placebo capsule once daily in the evening
Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS
Placebo tablet, two tablets once daily in the morning
|
Active Comparator: Montelukast 10mg and placebo
Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS
|
Inhaled placebo twice daily via ACCUHALER/DISKUS
Placebo tablet, two tablets once daily in the morning
Montelukast 10mg (1 x 10mg capsule) once daily in the evening
|
Placebo Comparator: Placebo Comparator
Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS
|
Placebo capsule once daily in the evening
Inhaled placebo twice daily via ACCUHALER/DISKUS
Placebo tablet, two tablets once daily in the morning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)
Time Frame: Baseline and Week 8
|
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second.
Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit.
Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value.
Analysis of covariance (ANCOVA) model used for statistical analysis.
ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants)
|
Baseline up to Week 8
|
Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit.
Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week 8
|
Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement.
Participant's responses to evening assessments indicated no symptoms were considered to be symptom free.
For participants, the symptom free days were assessed during the 8-Week treatment period.
Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value.
Baseline was defined as the last 7 days prior to randomization of the participants.
|
Baseline up to Week 8
|
Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement.
Participant's responses to the morning assessments indicated no symptoms were considered to be symptom free.
For participants, the symptom free nights were assessed during the 8-Week treatment period.
Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week 8
|
Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary.
The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period.
For participants, the rescue-free days were assessed during the 8-Week treatment period.
Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week 8
|
Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary.
The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period.
For participants, the rescue-free nights were assessed during the 8-Week treatment period.
Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week 8
|
Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period.
Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities.
Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week 8
|
Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period.
Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping.
Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week 8
|
Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period
Time Frame: Baseline up to Week
|
The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary.
Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period.
Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week
|
Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period
Time Frame: Baseline up to Week 8
|
The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary.
Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period.
Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
|
Baseline up to Week 8
|
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
Time Frame: Upto 8 Weeks
|
The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits.
4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication.
This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma.
The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).
|
Upto 8 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2010
Primary Completion (Actual)
October 6, 2011
Study Completion (Actual)
October 6, 2011
Study Registration Dates
First Submitted
June 17, 2010
First Submitted That Met QC Criteria
June 17, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Actual)
October 2, 2017
Last Update Submitted That Met QC Criteria
September 28, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Anti-Allergic Agents
- Montelukast
- Fluticasone
- Xhance
Other Study ID Numbers
- 112186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
-
Annotated Case Report Form
Information identifier: 112186Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 112186Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: 112186Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 112186Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 112186Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: 112186Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 112186Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on GSK2190915 10mg
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
GlaxoSmithKlineWithdrawn
-
GlaxoSmithKlineCompleted