Seasonal Allergic RhinitisPhase 2NCT00784732
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
A Phase 2 study testing QAV680 and Mometasone Furoate in people with Seasonal Allergic Rhinitis, run by Novartis at 1 site in Canada.
Trial summary
This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- QAV680 and Mometasone Furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Dec 2008
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive skin prick test to ragweed allergen
- FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2.
- Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2.
- Non-smokers and ex-smokers (≤10 pack years and >6 months of smoking abstinence).
- Understand and sign the written informed consent
Who cannot join
- Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing.
- Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Significant illness within two (2) weeks prior to initial dosing.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- QAV680, Mometasone Furoate
- Keywords
- Seasonal Allergic Rhinitis, Environmental Exposure Chamber, nasal lavage
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAV680Drug
QAV680Drug
Mometasone FuroateDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: QAV680 |
| 2 | Experimental | Not described Receives: Drug: QAV680 |
| 3 | Active comparator | Not described Receives: Drug: Mometasone Furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC
Measured: TNSS: 6-8h during EEC exposure on Day 10
Secondary outcomes (5)
Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)
Measured: After 8h exposure in EEC
Absolute eosinophil count from nasal lavage collected
Measured: During exposure in EEC
Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC
Measured: During exposure in EEC
Total Ocular Symptom Score measured during exposure in the EEC
Measured: During exposure in EEC
Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis
Measured: Through out study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Novartis Investigator Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784732
- Sponsor's protocol ID
- CQAV680A2202
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2008
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
- ClinicalTrials.gov ID
- NCT00784732
- Acronym / sponsor ID
- CQAV680A2202
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal Allergic Rhinitis, Environmental Exposure Chamber, nasal lavage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Nov 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.
This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QAV680 |
| 2 | Experimental | Drug: QAV680 |
| 3 | Active comparator | Drug: Mometasone Furoate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive skin prick test to ragweed allergen
- FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2.
- Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2.
- Non-smokers and ex-smokers (≤10 pack years and >6 months of smoking abstinence).
- Understand and sign the written informed consent
Key exclusion criteria (6 listed)
- Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing.
- Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Significant illness within two (2) weeks prior to initial dosing.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
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 |
|---|---|---|
| QAV680 | Drug | 1 |
| QAV680 | Drug | 2 |
| Mometasone Furoate | Drug | 3 |
Primary outcome
Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC
Time frame: TNSS: 6-8h during EEC exposure on Day 10
5 secondary outcomes
Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)
Time frame: After 8h exposure in EEC
Absolute eosinophil count from nasal lavage collected
Time frame: During exposure in EEC
Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC
Time frame: During exposure in EEC
Total Ocular Symptom Score measured during exposure in the EEC
Time frame: During exposure in EEC
Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis
Time frame: Through out study
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 18 Nov 2016.
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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.
Novartis principal investigator
Novartis Investigator Site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAV680 and Mometasone Furoate in people with Seasonal Allergic Rhinitis, run by Novartis at 1 site in Canada.
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 5 inclusion and 6 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 18 Nov 2016. 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC (time frame: TNSS: 6-8h during EEC exposure on Day 10). 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 18 Nov 2016.