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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00517946
First received: August 15, 2007
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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 Intervention
Seasonal Allergic Rhinitis
Sinusitis
Drug: pseudoephedrine hydrochloride
Drug: cetirizine hydrochloride

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 21
Study Start Date: March 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pseudoephedrine hydrochloride Drug: cetirizine hydrochloride
    Other Names:
    • pseudoephedrine hydrochloride
    • cetirizine hydrochloride
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517946

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00517946     History of Changes
Other Study ID Numbers: RES101509
Study First Received: August 15, 2007
Last Updated: August 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
anti-allergy.
seasonal allergic rhinitis (SAR),
intranasal allergen challenge,
MRI,

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Cetirizine
Ephedrine
Pseudoephedrine
Adrenergic Agents
Anti-Allergic Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Stimulants
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 24, 2014