Seasonal Allergic RhinitisNCT00517946
A Study To Investigate If MRI Scanning Is Effective At Seeing What Hayfever Drugs Do In Nasal Passage.
An observational study of Seasonal Allergic Rhinitis and Sinusitis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis, Sinusitis
- What is being tested?
- pseudoephedrine hydrochloride and cetirizine hydrochloride
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- pseudoephedrine hydrochloride, cetirizine hydrochloride
- Keywords
- anti-allergy., seasonal allergic rhinitis (SAR),, intranasal allergen challenge,, MRI,
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pseudoephedrine hydrochlorideDrug
cetirizine hydrochlorideDrug
Also called pseudoephedrine hydrochloride
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional airspace area (and thus also airspace volume) of the nasal passages
Measured: 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.
Measured: At 1hr post-dose and 30-60mins post-allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517946
- Sponsor's protocol ID
- RES101509
- Status last verified
- Aug 2013
- First submitted
- 15 Aug 2007
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00517946
- Acronym / sponsor ID
- RES101509
- Conditions
- Seasonal Allergic Rhinitis, Sinusitis
- Keywords
- anti-allergy., seasonal allergic rhinitis (SAR),, intranasal allergen challenge,, MRI,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pseudoephedrine hydrochloride | Drug | – |
| cetirizine hydrochlorideAlso: pseudoephedrine hydrochloride | Drug | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seasonal Allergic Rhinitis and Sinusitis, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.