A Study To Investigate If MRI Scanning Is Effective At Seeing What Hayfever Drugs Do In Nasal Passage.

NCT00517946 | Completed

• 1 other identifier: RES101509
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish whether MRI scanning is a sensitive measure of the effects of existing drug treatments on nasal dimensions following challenge with intranasal allergen in subjects with hayfever. If successful this technique could be applied to increase confidence for internal decision making and ultimately may be used to assess how effective a new drug treatment is.

Conditions

Seasonal Allergic Rhinitis; Sinusitis

Keywords

anti-allergy.; seasonal allergic rhinitis (SAR),; intranasal allergen challenge,; MRI,

Outcome Measures

Primary Outcomes (1)

• Cross-sectional airspace area (and thus also airspace volume) of the nasal passages

  at 1hr post-dose and 30-60mins post-allergen challenge.

Secondary Outcomes (1)

• Volume of fluid identified adjacent to the airspace. Mucosal surface area. Nasal cavity volume. Nasal tissue volume derived from the nasal cavity volume less airspace and fluid volumes.

  At 1hr post-dose and 30-60mins post-allergen challenge

Interventions

pseudoephedrine hydrochloride DRUG

cetirizine hydrochloride DRUG

Also known as: pseudoephedrine hydrochloride

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A medically diagnosed hay fever patient who is otherwise healthy.
• Aged 18 to 60 years.
• Body mass index less than 30 kg/m² with weight range of 50kg (females 45kg) to 100kg.
• A positive skin prick test (wheal = 3mm) for grass pollen at or within 12 months of starting the study and/or a positive RAST (= class 2) for grass pollen at or within 12 months of starting the study.
• Baseline FEV1 = 80% predicted and a baseline FEV1/FVC = 70% predicted (using standard predicted guidelines).
• Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
• Available to complete all study measurements.

You may not qualify if:

• Pregnant or nursing females.
• Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
• On examination the subject is found to have any nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, or nasopharyngeal surgery.
• Recent (within 3 weeks) or ongoing chest infection which in the physician responsible opinion renders the subject unsuitable for participation in the study.
• The subject has a history or current evidence of perennial rhinitis, sinusitis, or any other condition potentially or directly involving the nasal cavity, sinuses or nasopharynx.
• A history of any medical condition that would not allow the use of pseudoephedrine (e.g. hypertension, diabetes mellitus, ischaemic heart disease, raised intraocular pressure, hyperthyroidism, benign prostatic hyperplasia) or cetirizine (eg. antihistamine hypersensitivity).
• Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
• The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge.
• The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
• The subject has participated in another study during the previous 3 months.
• The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, oral contraceptives and herbal remedies.
• The subject regularly, or on average, drinks more than 4 units of alcohol per day - where 1 unit = ½ pint of beer (284mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
• The subject smokes more than 5 cigarettes per day.
• The subject has a history of porphyria.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, W1G 8HU, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Sinusitis

Interventions

Pseudoephedrine; Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

GB (1)