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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517946
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : September 2, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Seasonal Allergic Rhinitis Sinusitis Drug: pseudoephedrine hydrochloride Drug: cetirizine hydrochloride

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Study Type : Observational
Actual Enrollment : 21 participants
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 Start Date : March 2007
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Intervention Details:
  • Drug: pseudoephedrine hydrochloride
  • Drug: cetirizine hydrochloride
    Other Name: pseudoephedrine hydrochloride

Primary Outcome Measures :
  1. 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 Measures :
  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. [ Time Frame: At 1hr post-dose and 30-60mins post-allergen challenge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517946

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United Kingdom
GSK Investigational Site
London, United Kingdom, W1G 8HU
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT00517946     History of Changes
Other Study ID Numbers: RES101509
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by GlaxoSmithKline:
seasonal allergic rhinitis (SAR),
intranasal allergen challenge,

Additional relevant MeSH terms:
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Nasal Decongestants
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Paranasal Sinus Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Central Nervous System Stimulants
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents