Allergic RhinitisPhase 4NCT00679250
To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis
A Phase 4 study testing levocetirizine in people with Allergic Rhinitis, run by Brian J Lipworth at 2 sites in United Kingdom.
Trial summary
Allergic rhinitis is a common condition characterize by inflammation of the upper airways. Third generation antihistamines have been demonstrated effective in the treatment of this condition. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2005to Dec 2006
- Phase
- Phase 4
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female 16-75
- Patients with persistent rhinitis must be skin prick positive to house dust mite with perennial symptoms
- Patients with seasonal rhinitis should be skin prick positive to grass/tree pollen with seasonal symptoms
- Concomitant asthma is permitted in those with rhinitis if FEV1 >60%
- No recent exacerbations of asthma or chest infections if asthmatic
- Able to perform all of the techniques necessary to carry out challenge testing
- Must be compliant to study medication
- Must give informed consent
Who cannot join
- Male or female outwith the above age range
- Negative skin prick testing
- Patients with concomitant asthma with FEV1 less than 60% predicted
- Patients with asthma with recent chest infection or exacerbation
- Pregnant females, those at risk of becoming pregnant or breast feeding. Females must be on adequate contraception for the whole study period
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)
Dundee, Angus, DD1 9SY
Perth Royal Infirmary
Perth, Perthshire, PH1 1NX
About this study
Official title: A Placebo Controlled Trial to Evaluate The Effects of Levocetirizine on Nasal Allergen Challenge And Adenosine Monophosphate Challenge In Patients With Intermittent and Persistent Allergic Rhinitis
Allergic rhinitis is a common condition characterize by inflammation of the upper airways. Third generation antihistamines have been demonstrated effective in the treatment of this condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis, adenosine monophosphate may also be used as a means to investigate these effects but as yet its effects have yet to be compared to allergen challenge. We intend to compare the effects of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo in a double blind cross-over study. The study will include 20 patients with allergic rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment. The primary outcome variable will be the change in concentration of AMP/Allergen required to produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be deemed significant. We will also measure time to recovery after both challenges. AMP challenge is a safe alternative to allergen challenge and does not have the risk of anaphylaxis.
- Conditions
- Allergic Rhinitis
- Being tested
- levocetirizine, placebo to levocetirizine
- Keywords
- allergic rhinitis, levocetirizine, nasal provocation testing, nasal allergen challenge, nasal adenosine monophosphate challenge
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levocetirizineDrug
5 mg once nightly before visit
placebo to levocetirizineDrug
1 tablet once nightly before visit
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine | Experimental | Active drug Receives: Drug: levocetirizine |
| placebo | Placebo comparator | placebo to levocetirizine Receives: Drug: placebo to levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow.
Measured: 1 hour
Secondary outcomes (1)
Recovery Time Profile after nasal AMP and Allergen challenge
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startNov 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian J Lipworth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian J Lipworth, University of Dundee
- Investigators
- Arun Nair, MRCP, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679250
- Sponsor's protocol ID
- GRAY09
- Other IDs
- 2004-000683-27, 2004
- Status last verified
- Apr 2019
- First submitted
- 14 May 2008
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. doi: 10.1067/mai.2003.1592.
PubMed 12789212Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.
PubMed 11707753Clough GF, Boutsiouki P, Church MK. Comparison of the effects of levocetirizine and loratadine on histamine-induced wheal, flare, and itch in human skin. Allergy. 2001 Oct;56(10):985-8. doi: 10.1034/j.1398-9995.2001.00204.x.
PubMed 11576078Wang DY, Hanotte F, De Vos C, Clement P. Effect of cetirizine, levocetirizine, and dextrocetirizine on histamine-induced nasal response in healthy adult volunteers. Allergy. 2001 Apr;56(4):339-43. doi: 10.1034/j.1398-9995.2001.00775.x.
PubMed 11284803Lee DK, Gray RD, Wilson AM, Robb FM, Soutar PC, Lipworth BJ. Single and short-term dosing effects of levocetirizine on adenosine monophosphate bronchoprovocation in atopic asthma. Br J Clin Pharmacol. 2004 Jul;58(1):34-9. doi: 10.1111/j.1365-2125.2004.02110.x.
PubMed 15206990Terada N, Hamano N, Kim WJ, Hirai K, Nakajima T, Yamada H, Kawasaki H, Yamashita T, Kishi H, Nomura T, Numata T, Yoshie O, Konno A. The kinetics of allergen-induced eotaxin level in nasal lavage fluid: its key role in eosinophil recruitment in nasal mucosa. Am J Respir Crit Care Med. 2001 Aug 15;164(4):575-9. doi: 10.1164/ajrccm.164.4.2009046.
PubMed 11520718Wilson AM, Sims EJ, Orr LC, Robb F, Lipworth BJ. An evaluation of short-term corticosteroid response in perennial allergic rhinitis using histamine and adenosine monophosphate nasal challenge. Br J Clin Pharmacol. 2003 Apr;55(4):354-9. doi: 10.1046/j.1365-2125.2003.01776.x.
PubMed 12680883Vaidyanathan S, Nair A, Barnes ML, Meldrum K, Lipworth BJ. Effect of levocetirizine on nasal provocation testing with adenosine monophosphate compared with allergen challenge in allergic rhinitis. Clin Exp Allergy. 2009 Mar;39(3):409-16. doi: 10.1111/j.1365-2222.2008.03166.x.
PubMed 19187327
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Trial to Evaluate The Effects of Levocetirizine on Nasal Allergen Challenge And Adenosine Monophosphate Challenge In Patients With Intermittent and Persistent Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00679250
- Acronym / sponsor ID
- GRAY09
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, levocetirizine, nasal provocation testing, nasal allergen challenge, nasal adenosine monophosphate challenge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Brian J LipworthUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 May 2008 (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.
Allergic rhinitis is a common condition characterize by inflammation of the upper airways. Third generation antihistamines have been demonstrated effective in the treatment of this condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis, adenosine monophosphate may also be used as a means to investigate these effects but as yet its effects have yet to be compared to allergen challenge. We intend to compare the effects of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo in a double blind cross-over study. The study will include 20 patients with allergic rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment. The primary outcome variable will be the change in concentration of AMP/Allergen required to produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be deemed significant. We will also measure time to recovery after both challenges. AMP challenge is a safe alternative to allergen challenge and does not have the risk of anaphylaxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine | Experimental | Drug: levocetirizineActive drug |
| placebo | Placebo comparator | Drug: placebo to levocetirizineplacebo to levocetirizine |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 16-75
- Patients with persistent rhinitis must be skin prick positive to house dust mite with perennial symptoms
- Patients with seasonal rhinitis should be skin prick positive to grass/tree pollen with seasonal symptoms
- Concomitant asthma is permitted in those with rhinitis if FEV1 >60%
- No recent exacerbations of asthma or chest infections if asthmatic
Key exclusion criteria (5 listed)
- Male or female outwith the above age range
- Negative skin prick testing
- Patients with concomitant asthma with FEV1 less than 60% predicted
- Patients with asthma with recent chest infection or exacerbation
- Pregnant females, those at risk of becoming pregnant or breast feeding. Females must be on adequate contraception for the whole study period
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 |
|---|---|---|
| levocetirizine5 mg once nightly before visit | Drug | Levocetirizine |
| placebo to levocetirizine1 tablet once nightly before visit | Drug | placebo |
Primary outcome
Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow.
Time frame: 1 hour
1 secondary outcome
Recovery Time Profile after nasal AMP and Allergen challenge
Time frame: 1 hour
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 12 Apr 2019.
- Background: PubMed 12789212Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. doi: 10.1067/mai.2003.1592.
- Background: PubMed 11707753Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.
- Background: PubMed 11576078Clough GF, Boutsiouki P, Church MK. Comparison of the effects of levocetirizine and loratadine on histamine-induced wheal, flare, and itch in human skin. Allergy. 2001 Oct;56(10):985-8. doi: 10.1034/j.1398-9995.2001.00204.x.
- Background: PubMed 11284803Wang DY, Hanotte F, De Vos C, Clement P. Effect of cetirizine, levocetirizine, and dextrocetirizine on histamine-induced nasal response in healthy adult volunteers. Allergy. 2001 Apr;56(4):339-43. doi: 10.1034/j.1398-9995.2001.00775.x.
- Background: PubMed 15206990Lee DK, Gray RD, Wilson AM, Robb FM, Soutar PC, Lipworth BJ. Single and short-term dosing effects of levocetirizine on adenosine monophosphate bronchoprovocation in atopic asthma. Br J Clin Pharmacol. 2004 Jul;58(1):34-9. doi: 10.1111/j.1365-2125.2004.02110.x.
- Background: PubMed 11520718Terada N, Hamano N, Kim WJ, Hirai K, Nakajima T, Yamada H, Kawasaki H, Yamashita T, Kishi H, Nomura T, Numata T, Yoshie O, Konno A. The kinetics of allergen-induced eotaxin level in nasal lavage fluid: its key role in eosinophil recruitment in nasal mucosa. Am J Respir Crit Care Med. 2001 Aug 15;164(4):575-9. doi: 10.1164/ajrccm.164.4.2009046.
- Background: PubMed 12680883Wilson AM, Sims EJ, Orr LC, Robb F, Lipworth BJ. An evaluation of short-term corticosteroid response in perennial allergic rhinitis using histamine and adenosine monophosphate nasal challenge. Br J Clin Pharmacol. 2003 Apr;55(4):354-9. doi: 10.1046/j.1365-2125.2003.01776.x.
- Results publication: PubMed 19187327Vaidyanathan S, Nair A, Barnes ML, Meldrum K, Lipworth BJ. Effect of levocetirizine on nasal provocation testing with adenosine monophosphate compared with allergen challenge in allergic rhinitis. Clin Exp Allergy. 2009 Mar;39(3):409-16. doi: 10.1111/j.1365-2222.2008.03166.x.
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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.
Arun Nair, MRCP principal investigator
University of Dundee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levocetirizine in people with Allergic Rhinitis, run by Brian J Lipworth at 2 sites 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 8 inclusion and 5 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00679250, which also lists 8 linked publications.
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 12 Apr 2019.