seasonal allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Product Name: GSK1004723 Nasal Spray
Product Code: GSK1004723
Pharmaceutical Form: Nasal spray, suspension
Current Sponsor code: GSK1004723
Concentration unit: % (W/W) percent weight/weight
Concentrat
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. The subject is healthy with the exception of seasonal allergic rhinitis. The subject may also have mild asthma. Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. 2. Aged between 18 - 65 years. 3. Males. 4. Body weight = 50 kg and BMI within the range 19 - 32kg/m2. 5. They have a history of seasonal allergic rhinitis 6. They exhibit a moderate response to 4000 grass pollen grains/m3 within 2h in the Environmental Challenge Chamber, which is defined as a nasal symptom score of =6 at least once (Nasal symptom score is the sum of nasal blockage, rhinorrhoea, itch and sneeze, each of which have been scored on a scale from 0 to 3). 7. They have a positive skin prick test (wheal = 3mm) for Dactylis glomerata (at or within the 12 months preceding the screening visit). 8. They have a baseline FEV1 = 80% predicted. 9. A non-smoker for at least the past 12 months with a pack history of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the responsible Physician’s opinion renders the subject unsuitable for participation in the study. 2. Any respiratory disease other than mild stable intermittent asthma [Global Initiative for Asthma (GINA) Guidelines, 2003] that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function. 3. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or Nasal Spray. 4. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. 5. The subject has donated a unit of blood (450mL) within the previous 3 months or intends to donate within 3 months of completing the study. 6. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety. 7. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. 8. History of alcohol/drug abuse or dependence within 12 months of the study 9. Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. 10. The subject has a positive pre-study urine drug/breath alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines. 11. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. 12. The subject has tested positive for HIV antibodies. 13. The subject is at risk of non-compliance with the study procedures/restrictions. 14. Subjects showing clinical symptoms of perennial allergic rhinitis. 15. History of a respiratory tract infection and/or exacerbation of asthma within 3 weeks before the screening. 16. Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 3 weeks prior to the screening visit. 17. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of single doses of intranasal GSK1004723 on nasal symptoms of allergic rhinitis following 4 hrs in the allergen Challenge Chamber post-dose on day 1;Secondary Objective: •To investigate the effect of single doses of intranasal GSK1004723 on nasal airflow resistance in patients with allergic rhinitis following 4 hrs in the allergen Challenge Chamber post-dose on day 1. •To investigate the effect of single doses of intranasal GSK1004723 on weight of nasal secretions in patients with allergic rhinitis following 4 hrs in the allergen Challenge Chamber post-dose on day 1. •To investigate the effect of single doses of intranasal GSK1004723 on nasal symptoms of allergic rhinitis following 4h in the allergen Challenge Chamber on Day 2 (20 – 24h post-dose Day 1). ;Primary end point(s): Change from baseline in Total Nasal Symptom Score, TNSS (sneeze, itch, rhinorrhea, nasal blockage) 0-4h post-dose (2-6 hrs post start of allergen challenge). | — |
Countries
Germany
Outcome results
None listed