Clinical trial NCT02446613: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma and Rhinitis
Keywords: Allergic Rhinitis
Nasal allergen challenge
Allergic Asthma
Effect on Allergen Reactivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)
timeFrame: Day 1 (Baseline [pre-NAC] and post-NAC 15 min)
measure: Mean Change From Baseline in the TNSS Over Post-NAC 1 h
timeFrame: Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)
measure: Mean Change From Baseline in the TNSS Over Post-NAC 6 h
timeFrame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
measure: Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h
timeFrame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
measure: Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min
timeFrame: Day 1 (Baseline [pre-NAC] and post-NAC 15 min)
measure: Percent Change From Baseline in the PNIF Over Post-NAC 1 h
timeFrame: Day 1 (Baseline [pre-NAC] to post-NAC 1 h)
measure: Percent Change From Baseline in the PNIF up to Post-NAC 6 h
timeFrame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
measure: Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h
timeFrame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
Secondary outcomes:
measure: Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.
timeFrame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: