Allergic RhinitisPhase 4NCT02543346
Comparability and Standardization of Controlled Allergen Challenge Facilities
A Phase 4 study testing Cetirizine in people with Allergic Rhinitis, run by Queen's University at 2 sites in 2 countries.
Trial summary
Allergen challenge facilities have been utilized for many years in clinical drug trials studying onset of action, proof of concept, duration of action, and efficacy. Each facility has somewhat different design characteristics and pollen dispersal technologies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2015to May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of rhinoconjunctivitis during ragweed season for a minimum of 2 years, including the previous 2 ragweed seasons.
- positive skin test to ragweed allergen.
Who cannot join
- participant is pregnant, lactating or actively trying to conceive.
- has a history of receiving immunotherapy containing short ragweed within the last 3 years.
- participant has current allergy symptoms.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Biogenics Research Chamber
San Antonio, Texas, 78229
About this study
Allergen challenge facilities have been utilized for many years in clinical drug trials studying onset of action, proof of concept, duration of action, and efficacy. Each facility has somewhat different design characteristics and pollen dispersal technologies. Facilities are located in disparate geographic areas and have populations of participants who are sensitized to allergens unique to that area. Therefore, facilities have operated as single sites with little effort to evaluate facility comparability or to attempt standardization across facilities. The purpose of this study is to compare the two sites and assess whether the sites are able to achieve similar symptom scores.
Read the detailed description
When CACF have been designed with a high degree of rigor, quality assurance and validation testing, the exposure to controlled levels of pollen in such facilities as the Environmental Exposure Unit (EEU) and the Biogenics Research Chamber (BRC) will demonstrate comparable/standardized symptomatic responses. This will be demonstrable not only following pollen exposure but will also have similar reductions in symptoms following treatment with a Food and Drug Administration (FDA) approved medication known to be effective for the treatment of seasonal allergic rhinoconjunctivitis ( SAR); cetirizine 10mg. Because of quality assurance and validation testing completed at these facilities a priori, this comparability will be demonstrated despite their disparate geographical physical locations and the utilization of these facilities of somewhat different mechanical and technical materials and methods to achieve similar outcomes.
This multi-center study of SAR will enroll 50 participants at each site. These participants will be age 18-65, male and female, with a mixture of ethnic groups. The study will involve 3 Phases: Screening, Treatment Exposure Visit, and a cross-over Treatment Exposure Visit. In all stages, a CACF visit will be pivotal to determine participant eligibility for enrollment and response to therapy. The qualifying participants will receive a double-blinded, placebo-controlled, crossover intervention with cetirizine HCl 10mg.
All participants will give written informed consent prior to any study related procedures being performed. Participants who meet all inclusion/exclusion criteria during the screening process will be asked to return to the EEU for their first pollen exposure visit (Treatment Visit #1). At the Screening Visit participants will provide a full medical history and undergo a physical examination. They will have their height/weight and vitals measured and skin testing will be performed to confirm allergic response to a panel of common aeroallergens. Women of child bearing potential will undergo a urine pregnancy test to rule out pregnancy. Eligible participants will be invited back to the research centre for 4 pollen exposure visits at 2 of these visits participants will receive either cetirizine or placebo. All participants will receive placebo at some point throughout the study.
- Conditions
- Allergic Rhinitis
- Being tested
- Cetirizine, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Also called Zyrtec, Reactine
Participants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits.
PlaceboOther
Participants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits
| Study group | Role | What they receive |
|---|---|---|
| cetirizine hydrochloride | Other | Not described Receives: Drug: Cetirizine |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.
The TRSS is a composite score comprised of 4 nasal (runny nose, sneezing, nasal itch, nasal congestion) and 3 ocular (itchy eyes, watery eyes, red/burning eyes) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TRSS of 21 (0 to 21).The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity.
Measured: First treatment visit and second treatment visit.
Secondary outcomes (4)
Comparison of TNSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.
The Total Nasal Symptom Score (TNSS) is a composite score comprised of 4 nasal (runny nose, sneezing, nasal itch, nasal congestion) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TNSS of 12 (0 to 12) .The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity.
Measured: First treatment visit and second treatment visit.
Comparison of TOSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.
The Total Ocular Symptom Score (TOSS) is a composite score comprised of 3 ocular (itchy eyes, watery eyes, red/burning eyes) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TOSS of 9 (0 to 9) .The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity.
Measured: First treatment visit and second treatment visit.
Comparison of GRCS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Participants recorded how they were feeling at baseline and at the end of both treatment visits.
The Global Rating of Change Scale documents the changes in the participant's emotions. The scale ranges from +7 (A very great deal better) to -7 (A very great deal worse) with 0 being no change. A higher score indicates a better outcome.
Measured: First treatment visit and second treatment visit.
Comparison of VAS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Participants recorded the severity of all nasal and ocular symptoms at baseline and at the end of both treatment visits.
The Visual Analogue Scale (VAS) is a single overall rating of the severity of all nasal and ocular symptoms experienced by the participant. The scale ranges from 0 to 100 mm with 0 mm being no symptoms and 100 mm being the worst symptoms the participant has ever felt.
Measured: First treatment visit and second treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Biogenics Research Chamber, LLC
- Responsible party
- Principal investigator, Dr. Anne Ellis, Queen's University
- Investigators
- Anne K Ellis, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543346
- Sponsor's protocol ID
- EEU-BRC-001
- Status last verified
- Mar 2019
- First submitted
- 2 Sep 2015
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparability and Standardization of Controlled Allergen Challenge Facilities
- ClinicalTrials.gov ID
- NCT02543346
- Acronym / sponsor ID
- EEU-BRC-001
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Biogenics Research Chamber, LLC
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 9 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allergen challenge facilities have been utilized for many years in clinical drug trials studying onset of action, proof of concept, duration of action, and efficacy. Each facility has somewhat different design characteristics and pollen dispersal technologies. Facilities are located in disparate geographic areas and have populations of participants who are sensitized to allergens unique to that area. Therefore, facilities have operated as single sites with little effort to evaluate facility comparability or to attempt standardization across facilities. The purpose of this study is to compare the two sites and assess whether the sites are able to achieve similar symptom scores.
Detailed description
When CACF have been designed with a high degree of rigor, quality assurance and validation testing, the exposure to controlled levels of pollen in such facilities as the Environmental Exposure Unit (EEU) and the Biogenics Research Chamber (BRC) will demonstrate comparable/standardized symptomatic responses. This will be demonstrable not only following pollen exposure but will also have similar reductions in symptoms following treatment with a Food and Drug Administration (FDA) approved medication known to be effective for the treatment of seasonal allergic rhinoconjunctivitis ( SAR); cetirizine 10mg. Because of quality assurance and validation testing completed at these facilities a priori, this comparability will be demonstrated despite their disparate geographical physical locations and the utilization of these facilities of somewhat different mechanical and technical materials and methods to achieve similar outcomes.
This multi-center study of SAR will enroll 50 participants at each site. These participants will be age 18-65, male and female, with a mixture of ethnic groups. The study will involve 3 Phases: Screening, Treatment Exposure Visit, and a cross-over Treatment Exposure Visit. In all stages, a CACF visit will be pivotal to determine participant eligibility for enrollment and response to therapy. The qualifying participants will receive a double-blinded, placebo-controlled, crossover intervention with cetirizine HCl 10mg.
All participants will give written informed consent prior to any study related procedures being performed. Participants who meet all inclusion/exclusion criteria during the screening process will be asked to return to the EEU for their first pollen exposure visit (Treatment Visit #1). At the Screening Visit participants will provide a full medical history and undergo a physical examination. They will have their height/weight and vitals measured and skin testing will be performed to confirm allergic response to a panel of common aeroallergens. Women of child bearing potential will undergo a urine pregnancy test to rule out pregnancy. Eligible participants will be invited back to the research centre for 4 pollen exposure visits at 2 of these visits participants will receive either cetirizine or placebo. All participants will receive placebo at some point throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cetirizine hydrochloride | Other | Drug: Cetirizine |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- history of rhinoconjunctivitis during ragweed season for a minimum of 2 years, including the previous 2 ragweed seasons.
- positive skin test to ragweed allergen.
Key exclusion criteria (3 listed)
- participant is pregnant, lactating or actively trying to conceive.
- has a history of receiving immunotherapy containing short ragweed within the last 3 years.
- participant has current allergy symptoms.
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 |
|---|---|---|
| CetirizineAlso: Zyrtec, ReactineParticipants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits. | Drug | cetirizine hydrochloride |
| PlaceboParticipants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits | Other | placebo |
Primary outcome
Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Time frame: First treatment visit and second treatment visit.
Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits. The TRSS is a composite score comprised of 4 nasal (runny nose, sneezing, nasal itch, nasal congestion) and 3 ocular (itchy eyes, watery eyes, red/burning eyes) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TRSS of 21 (0 to 21).The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity.
4 secondary outcomes
Comparison of TNSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Time frame: First treatment visit and second treatment visit.
Comparison of TOSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Time frame: First treatment visit and second treatment visit.
Comparison of GRCS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Time frame: First treatment visit and second treatment visit.
Comparison of VAS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Time frame: First treatment visit and second treatment visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Allergic Rhinitis
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Allergy, Asthma, and Atopic Eczema in Finland
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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.
Anne K Ellis, MD principal investigator
Queen's University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetirizine in people with Allergic Rhinitis, run by Queen's University at 2 sites in 2 countries.
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 2 inclusion and 3 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 9 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 States, Canada. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups. (time frame: First treatment visit and second treatment visit.). 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 9 Apr 2019; AzTrials last refreshed its copy on 1 Nov 2026.