Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Allergic Rhinitis

Treatments

Other: Placebo
Drug: GSK1004723 (1000mg)
Drug: GSK1004723 (200mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00824356
723 PoC
110159

Details and patient eligibility

About

This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic

Enrollment

54 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
  • Male
  • Aged 18 - 65
  • Weight 50kg+, BMI 19-32 kg/m2
  • Exhibit response to Challenge Chamber and skin prick test.
  • Non-smoker
  • Capable of giving informed consent

Exclusion criteria

  • No nasal structural abnornmality/polyposis, surgery, infection.
  • any respiratory disease, other than mild asthma or seasonal allergic rhinitis
  • participated in another clinical study within 30 days.
  • Subject has donated a unit of blood within 1 month
  • Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
  • History of sensitivty to drug
  • History of alcohol/drug abuse within 12 months.
  • Positive Hepatitis B antibody test
  • Positive HIV antibody test
  • Risk of non-compliance with study protocol
  • Perenial allergic rhinitis
  • Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
  • Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

54 participants in 3 patient groups, including a placebo group

GSK1004726 (1000mg)
Active Comparator group
Description:
1000mg aqueous suspension
Treatment:
Drug: GSK1004723 (1000mg)
Placebo
Placebo Comparator group
Description:
Intranasal spray
Treatment:
Drug: GSK1004723 (1000mg)
Other: Placebo
GSK1004723 (200mg)
Active Comparator group
Description:
200 mg aqueous suspension
Treatment:
Drug: GSK1004723 (200mg)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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