Asthma and RhinitisPhase 2NCT02446613

Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958

A Phase 2 study testing Pollen allergen extract in people with Asthma and Rhinitis, run by GlaxoSmithKline at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma and Rhinitis
What is being tested?: Pollen allergen extract
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteCanada
Study dates: 22 Jun 2015to 10 Aug 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

GSK Investigational Site
Kingston, Ontario, K7L 2V7

Other trials in Canada

About this study

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

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.

Conditions: Asthma and Rhinitis
Being tested: Pollen allergen extract
Keywords: Allergic Rhinitis, Nasal allergen challenge, Allergic Asthma, Effect on Allergen Reactivity
Medical subject headings: Asthma, Rhinitis, Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pollen allergen extractOther
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.

Study groups in NCT02446613
Study group	Role	What they receive
Nasal allergen challenge	Other	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. Receives: Other: Pollen allergen extract

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 (Baseline [pre-NAC] and post-NAC 15 min)
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.
Measured: Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)
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.
Measured: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
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.
Measured: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
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.
Measured: Day 1 (Baseline [pre-NAC] and post-NAC 15 min)
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.
Measured: Day 1 (Baseline [pre-NAC] to post-NAC 1 h)
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.
Measured: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
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.
Measured: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Secondary outcomes (1)

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.
Measured: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 201510 Aug 2015

First posted18 May 2015 (estimated)
Study start22 Jun 2015
Primary completion10 Aug 2015
Study completion10 Aug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Asthma and RhinitisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02446613
Sponsor's protocol ID: 204509
Status last verified: Mar 2018
First submitted: 14 May 2015
Last updated: 4 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02446613
Acronym / sponsor ID: 204509
Conditions: Asthma and Rhinitis
Keywords: Allergic Rhinitis, Nasal allergen challenge, Allergic Asthma, Effect on Allergen Reactivity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 22 Jun 2015 (actual)
Primary completion: 10 Aug 2015 (actual)
Study completion: 10 Aug 2015 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 15 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 1

Arm	Type	Receives
Nasal allergen challenge	Other	Other: Pollen allergen extractSubjects 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pollen allergen extractPollen (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.	Other	Nasal allergen challenge

Primary outcome

Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)
Time frame: Day 1 (Baseline [pre-NAC] and post-NAC 15 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
Time frame: Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)
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
Time frame: Day 1 (Baseline [pre-NAC] to 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
Time frame: Day 1 (Baseline [pre-NAC] to 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
Time frame: Day 1 (Baseline [pre-NAC] and 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
Time frame: Day 1 (Baseline [pre-NAC] to 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
Time frame: Day 1 (Baseline [pre-NAC] 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
Time frame: Day 1 (Baseline [pre-NAC] 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). Maximum change from Baseline till 6h was reported.

1 secondary outcome

Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.
Time frame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Results and safety

Results posted to the registry on 15 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Once Weekly	6	6
GSK2245035 20 ng, i.n., Once Weekly	10	10

Primary outcome: Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)

Time frame: Day 1 (Baseline [pre-NAC] and post-NAC 15 min). Median (95% Confidence Interval). Unit: Score on a scale

Measure	Placebo Once Weekly n = 6	GSK2245035 20 ng, i.n., Once Weekly n = 10
Value	3.8 (1.22 to 6.53)	5.9 (3.91 to 7.81)

Placebo Once Weekly vs GSK2245035 20 ng, i.n., Once Weekly: Mean Difference (Final Values): 2.1 (95% CI -1.41 to 5.43)

Population analysed: The Safety population consisted of members of the ASP of parent study TL7116958 who had passed screening for study 204509.

Primary outcome: Mean Change From Baseline in the TNSS Over Post-NAC 1 h

Time frame: Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h). Median (95% Confidence Interval). Unit: Score on a scale

Measure	Placebo Once Weekly n = 6	GSK2245035 20 ng, i.n., Once Weekly n = 10
Value	2.4 (0.24 to 4.63)	3.4 (1.70 to 4.96)

Placebo Once Weekly vs GSK2245035 20 ng, i.n., Once Weekly: Mean Difference (Final Values): 1.0 (95% CI -1.98 to 3.75)

Population analysed: Safety population

Primary outcome: Mean Change From Baseline in the TNSS Over Post-NAC 6 h

Time frame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h). Median (95% Confidence Interval). Unit: Score on a scale

Measure	Placebo Once Weekly n = 6	GSK2245035 20 ng, i.n., Once Weekly n = 10
Value	1.2 (0.04 to 2.33)	1.6 (0.73 to 2.44)

Placebo Once Weekly vs GSK2245035 20 ng, i.n., Once Weekly: Median Difference (Final Values): 0.4 (95% CI -1.08 to 1.87)

Population analysed: Safety population

Primary outcome: Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h

Time frame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h). Median (95% Confidence Interval). Unit: Score on a scale

Measure	Placebo Once Weekly n = 6	GSK2245035 20 ng, i.n., Once Weekly n = 10
Value	4.1 (1.41 to 6.80)	5.9 (3.83 to 7.87)

Placebo Once Weekly vs GSK2245035 20 ng, i.n., Once Weekly: Median Difference (Final Values): 1.9 (95% CI -1.86 to 5.34)

Population analysed: Safety population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) were collected from participant's consent for participation in the study till follow-up contact (4 to 7 day post Visit 2). Adverse events (AEs) were collected from the start of Study Visit 2 NAC until the follow-up contact.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Once Weekly	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
GSK2245035 20 ng, i.n., Once Weekly	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
RecruitingObservational study
A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up
Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pollen allergen extract in people with Asthma and Rhinitis, run by GlaxoSmithKline at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min) (time frame: Day 1 (Baseline [pre-NAC] and post-NAC 15 min)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.