Trial Outcomes & Findings for Effect of the GSK2245035 on the Allergen-induced Asthmatic Response (NCT NCT02833974)
NCT ID: NCT02833974
Last Updated: 2021-03-26
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to bronchial allergen challenge (BAC) at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. Per-Protocol Population comprises of all randomized participants who received at least one dose of study treatment and commence a BAC at follow-up and comply with the protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Week 9
Results posted on
2021-03-26
Participant Flow
This study investigated the safety, pharmacodynamics, and effect of the Toll-like receptor 7 (TLR7) agonist, GSK2245035, on allergen-induced asthmatic response in participants with mild allergic asthma. Participants received either intranasal 20 nanogram (ng) GSK2245035 or placebo once weekly for 8 weeks.
A total of 36 participants were randomized at different centers in United Kingdom and Germany..
Participant milestones
| Measure |
Placebo
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
22
|
|
Overall Study
COMPLETED
|
13
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
Baseline Characteristics
Effect of the GSK2245035 on the Allergen-induced Asthmatic Response
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.6 Years
STANDARD_DEVIATION 12.26 • n=93 Participants
|
36.0 Years
STANDARD_DEVIATION 11.65 • n=4 Participants
|
36.3 Years
STANDARD_DEVIATION 11.72 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 Count of Participants
n=93 Participants
|
2 Count of Participants
n=4 Participants
|
2 Count of Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 Count of Participants
n=93 Participants
|
1 Count of Participants
n=4 Participants
|
1 Count of Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Count of Participants
n=93 Participants
|
19 Count of Participants
n=4 Participants
|
33 Count of Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 9Population: Per-Protocol Population. Only those participants with data available at specified time points were analyzed
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to bronchial allergen challenge (BAC) at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. Per-Protocol Population comprises of all randomized participants who received at least one dose of study treatment and commence a BAC at follow-up and comply with the protocol.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=17 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum Forced Expiratory Volume in 1 Second (FEV1) Between 4-10 Hours Following Allergen Challenge One Week After Treatment
|
-1.107 Liters
Standard Deviation 0.7195
|
-0.885 Liters
Standard Deviation 0.5353
|
PRIMARY outcome
Timeframe: Week 9Population: Per-Protocol Population. Only those participants with data available at specified time points were analyzed
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 4-10 hours post-allergen challenge includes all post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=17 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
LAR: Absolute Change From Saline in Weighted Mean FEV1 Between 4-10 Hours Following Allergen Challenge One Week After Treatment
|
-0.546 Liters
Standard Deviation 0.3932
|
-0.576 Liters
Standard Deviation 0.4018
|
SECONDARY outcome
Timeframe: Week 9Population: Per-Protocol Population. Only those participants with data available at specified time points were analyzed
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 0-2 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 0 and 2 hours post-allergen challenge, inclusive of the 0 and 2 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=17 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment
|
-1.246 Liters
Standard Deviation 0.6052
|
-1.096 Liters
Standard Deviation 0.4113
|
SECONDARY outcome
Timeframe: Week 9Population: Per-Protocol Population. Only those participants with data available at specified time points were analyzed
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 0-2 hours post-allergen challenge includes all post-saline time points between 0-2 hours post-allergen challenge, inclusive of 0 and 2 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=17 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment.
|
-0.604 Liters
Standard Deviation 0.2670
|
-0.587 Liters
Standard Deviation 0.2388
|
SECONDARY outcome
Timeframe: Up to Week 20Population: All Subjects Population comprise of all participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
10 Participants
|
21 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All Subjects Population
The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated. Participants were instructed to record their PEF readings each morning and evening into the diary card that was provided by the investigator. The minimum and maximum range ranges for PEF were \<=205 and \>=980 liters per minute.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Peak Expiratory Flow (PEF)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 20Population: All Subjects Population
Salbutamol was administered as rescue medication only to participants who experienced serious discomfort. The data below exclude any Salbutamol administered as part of the planned study procedures (for example the Salbutamol administered after the Bronchial Allergen Challenge \[BAC\] is not counted as a rescue medication).
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Number of Participants Receiving Rescue Medication
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 20Population: All Subjects Population.
Blood samples were collected for analysis of hematology parameters. Hematology parameters included hematocrit, hemoglobin, platelet count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and red blood cells (RBC).
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Number of Participants With Hematology Values of Potential Clinical Concern
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to Week 8Population: All Subjects Population.
Blood samples were collected for analysis of clinical chemistry parameters. Clinical chemistry parameters included blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, total and direct bilirubin, albumin, calcium, creatinine, glucose, potassium and sodium.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Number of Participants With Clinical Chemistry Values of Potential Clinical Concern
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 8Population: All Subjects Population.
Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 Participants
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Urine Analysis Findings
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
GSK2245035 20 ng
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
|
GSK2245035 20 ng
n=22 participants at risk
Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
57.1%
8/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
40.9%
9/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Parosmia
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
27.3%
6/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
13.6%
3/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacterial rhinitis
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
31.8%
7/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
9.1%
2/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
9.1%
2/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
9.1%
2/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
9.1%
2/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
18.2%
4/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Seasonal allergy
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Peak expiratory flow rate decreased
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/14 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
4.5%
1/22 • Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
All Subjects Population comprised of all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER