Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958
Condition: Asthma and Rhinitis
MeSH terms: Rhinitis
Intervention: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Allergic Rhinitis; Nasal allergen challenge; Allergic Asthma; Effect on Allergen Reactivity

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.