A Study To Investigate If MRI Scanning Is Effective At Seeing What Hayfever Drugs Do In Nasal Passage.
Primary Purpose
Seasonal Allergic Rhinitis, Sinusitis
Status
Completed
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
pseudoephedrine hydrochloride
cetirizine hydrochloride
Sponsored by
About this trial
This is an observational trial for Seasonal Allergic Rhinitis focused on measuring anti-allergy., seasonal allergic rhinitis (SAR),, intranasal allergen challenge,, MRI,
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Cross-sectional airspace area (and thus also airspace volume) of the nasal passages
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00517946
Brief Title
A Study To Investigate If MRI Scanning Is Effective At Seeing What Hayfever Drugs Do In Nasal Passage.
Official Title
An Investigation to Evaluate the Technique of MRI as an Assessment of the Effect of Anti-allergy Drug Treatment on Internal Nasal and Sinus Mucosal Anatomy Following Intranasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis.
Study Type
Observational
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Sinusitis
Keywords
anti-allergy., seasonal allergic rhinitis (SAR),, intranasal allergen challenge,, MRI,
7. Study Design
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
pseudoephedrine hydrochloride
Intervention Type
Drug
Intervention Name(s)
cetirizine hydrochloride
Other Intervention Name(s)
pseudoephedrine hydrochloride
Primary Outcome Measure Information:
Title
Cross-sectional airspace area (and thus also airspace volume) of the nasal passages
Time Frame
at 1hr post-dose and 30-60mins post-allergen challenge.
Secondary Outcome Measure Information:
Title
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.
Time Frame
At 1hr post-dose and 30-60mins post-allergen challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W1G 8HU
Country
United Kingdom
12. IPD Sharing Statement
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