Back to resultsFollow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958
Primary Purpose
Asthma and Rhinitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Pollen allergen extract
Sponsored by
About this trial
This is an interventional treatment trial for Asthma and Rhinitis focused on measuring Allergic Rhinitis, Nasal allergen challenge, Allergic Asthma, Effect on Allergen Reactivity
Eligibility Criteria
Inclusion Criteria:
- Adult subjects with allergic rhinitis who completed study TL7116958 in 2014.
- Healthy as determined by the investigator or medically qualified designee based on a brief physical examination.
- Males and non-pregnant females.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion Criteria:
- Unresolved respiratory tract infection (RTI) at the time of study visit 2 NAC. Investigator discretion will be used regarding RTIs that have resolved during the 4 weeks preceding study visit 2.
- Unresolved asthma exacerbation requiring hospitalization and/or treatment with oral steroids or high doses of inhaled steroids at the time of study visit 2 NAC.
Investigator discretion will be used regarding exacerbations that have resolved since screening visit.
- A change in medical history since completion of the study TLR7116958 that in the opinion of the investigator and GlaxoSmithKline (GSK) medical monitor may pose additional risk factors.
- Subjects with a history of treatment with allergen-specific immunotherapy since completion of the TL7116958 study; subjects that have taken an investigational drug that, in the opinion of the investigator or designee, would have an effect on the nasal allergen challenge
- Subjects using steroid treatment (nasal steroids, 4 weeks; oral steroids, 4 weeks; inhaled steroids, 4 weeks) for allergic rhinitis and/or asthma prior to study visit 2, nasal allergen challenge
- Subjects using antihistamines (nasal antihistamines, 48 hours; oral antihistamines 72 hours), decongestants (nasal decongestants, 24 hours; oral decongestants, 24 hours.), prior to study visit 2, nasal allergen challenge.
- Subject is mentally or legally incapacitated.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nasal allergen challenge
Arm Description
Subjects do not receive study medication in this study 204509. Subjects who carried from study TL7116958 treatment group GSK2245035 will undergo NAC with pollen allergen extract.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)
TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value.
Mean Change From Baseline in the TNSS Over Post-NAC 1 h
TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported.
Mean Change From Baseline in the TNSS Over Post-NAC 6 h
TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported.
Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h
TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period.
Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min
PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.
Percent Change From Baseline in the PNIF Over Post-NAC 1 h
PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.
Percent Change From Baseline in the PNIF up to Post-NAC 6 h
PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.
Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h
PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported.
Secondary Outcome Measures
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.
Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02446613
Brief Title
Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958
Official Title
A Single-centre, Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Who Completed Treatment in Study TL7116958 in 2014
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 22, 2015 (Actual)
Primary Completion Date
August 10, 2015 (Actual)
Study Completion Date
August 10, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the duration of effect of GSK2245035 on allergic reactivity by repeating a nasal allergen challenge (NAC) approximately one year after treatment in subjects from TL7116958. This is a single centre, single period study in subjects with respiratory allergy/allergies who completed the study TL7116958 in 2014 to investigate the long term effect of previous treatment with GSK2245035 compared with placebo on total nasal symptoms elicited by nasal allergen challenge. Subjects and staff will remain blinded to the treatment received in the TL7116958 study (GSK2245035 or placebo). The study will consist of a screening visit to assess eligibility criteria, a study period consisting of a single visit when the nasal allergen challenge will be performed, and follow up by phone or a clinic visit at the discretion of the investigator 4-7 days following the allergen challenge. Eligible subjects will participate in this study for approximately70 days total from screening to follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma and Rhinitis
Keywords
Allergic Rhinitis, Nasal allergen challenge, Allergic Asthma, Effect on Allergen Reactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal allergen challenge
Arm Type
Other
Arm Description
Subjects do not receive study medication in this study 204509. Subjects who carried from study TL7116958 treatment group GSK2245035 will undergo NAC with pollen allergen extract.
Intervention Type
Other
Intervention Name(s)
Pollen allergen extract
Intervention Description
Pollen (tree, grass or ragweed) allergen extracts will be provided by the research unit and diluted as required in normal saline. The specific pollen allergen extract that will be used for the nasal allergen challenge will be selected according to each subject's individual allergic sensitivity demonstrated in the previous study, TL7116958. If possible, extracts remaining from this study in 2014 will be used, provided they have not reached their expiry date.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)
Description
TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value.
Time Frame
Day 1 (Baseline [pre-NAC] and post-NAC 15 min)
Title
Mean Change From Baseline in the TNSS Over Post-NAC 1 h
Description
TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported.
Time Frame
Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)
Title
Mean Change From Baseline in the TNSS Over Post-NAC 6 h
Description
TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported.
Time Frame
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
Title
Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h
Description
TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period.
Time Frame
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
Title
Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min
Description
PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.
Time Frame
Day 1 (Baseline [pre-NAC] and post-NAC 15 min)
Title
Percent Change From Baseline in the PNIF Over Post-NAC 1 h
Description
PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.
Time Frame
Day 1 (Baseline [pre-NAC] to post-NAC 1 h)
Title
Percent Change From Baseline in the PNIF up to Post-NAC 6 h
Description
PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.
Time Frame
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
Title
Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h
Description
PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported.
Time Frame
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.
Description
Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value.
Time Frame
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects with allergic rhinitis who completed study TL7116958 in 2014.
Healthy as determined by the investigator or medically qualified designee based on a brief physical examination.
Males and non-pregnant females.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion Criteria:
Unresolved respiratory tract infection (RTI) at the time of study visit 2 NAC. Investigator discretion will be used regarding RTIs that have resolved during the 4 weeks preceding study visit 2.
Unresolved asthma exacerbation requiring hospitalization and/or treatment with oral steroids or high doses of inhaled steroids at the time of study visit 2 NAC.
Investigator discretion will be used regarding exacerbations that have resolved since screening visit.
A change in medical history since completion of the study TLR7116958 that in the opinion of the investigator and GlaxoSmithKline (GSK) medical monitor may pose additional risk factors.
Subjects with a history of treatment with allergen-specific immunotherapy since completion of the TL7116958 study; subjects that have taken an investigational drug that, in the opinion of the investigator or designee, would have an effect on the nasal allergen challenge
Subjects using steroid treatment (nasal steroids, 4 weeks; oral steroids, 4 weeks; inhaled steroids, 4 weeks) for allergic rhinitis and/or asthma prior to study visit 2, nasal allergen challenge
Subjects using antihistamines (nasal antihistamines, 48 hours; oral antihistamines 72 hours), decongestants (nasal decongestants, 24 hours; oral decongestants, 24 hours.), prior to study visit 2, nasal allergen challenge.
Subject is mentally or legally incapacitated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
204509
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
204509
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
204509
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
204509
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
204509
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
204509
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
204509
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958
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