CompletedPhase 2

Intranasal SB-705498 in Allergic Rhinitis (AR) Patients

Austria70 participantsStarted 2011-04-14

Plain-language summary

This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities.
✓. TNSS score of \>=4 following screening allergen challenge chamber.
✓. Positive skin prick test for seasonal pollen
✓. Positive RAST for seasonal pollen
✓. Healthy as determined by responsible physician with the exception of mild asthma and AR
✓. Male or female between 18 and 65 years of age inclusive.
✓. A female subject is eligible to participate if she is of:
✓. Male subjects with female partners of child-bearing potential must agree to use one contraception as instructed. This must be followed from the time of the first dose of study medication until 84 days post-last treatment administration.

✕. Nasal abnormalities likely to affect the outcome of the study,
✕. History of frequent nosebleeds.
✕. Respiratory disease other than mild asthma
✕. A positive pre-study Hepatitis B or Hepatitis C result within 3 months of screening
✕. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
✕. Positive pre-study drug/alcohol/smoking screen.
✕. A positive test for HIV antibody.
✕. History of regular alcohol consumption within 6 months of the study defined as:

Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8

Timeframe: Day 8 of each treatment period

NCT IDNCT01424397

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07-07

Results submitted2017-08-15

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities.
✓. TNSS score of \>=4 following screening allergen challenge chamber.
✓. Positive skin prick test for seasonal pollen
✓. Positive RAST for seasonal pollen
✓. Healthy as determined by responsible physician with the exception of mild asthma and AR
✓. Male or female between 18 and 65 years of age inclusive.
✓. A female subject is eligible to participate if she is of:
✓. Male subjects with female partners of child-bearing potential must agree to use one contraception as instructed. This must be followed from the time of the first dose of study medication until 84 days post-last treatment administration.

✕. Nasal abnormalities likely to affect the outcome of the study,
✕. History of frequent nosebleeds.
✕. Respiratory disease other than mild asthma
✕. A positive pre-study Hepatitis B or Hepatitis C result within 3 months of screening
✕. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
✕. Positive pre-study drug/alcohol/smoking screen.
✕. A positive test for HIV antibody.
✕. History of regular alcohol consumption within 6 months of the study defined as: