Allergic RhinitisPhase 2NCT01103050
A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine
A Phase 2 study testing QAV680 + Cetirizine in people with Allergic Rhinitis, run by Novartis Pharmaceuticals at 1 site in Canada.
Trial summary
This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or… 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?
- QAV680 + Cetirizine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 22 Mar 2010to 28 Jul 2010
- 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
- Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons
- positive skin prick test to ragweed allergen within twelve months of screening
Who cannot join
- Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes)
- Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease
- Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in an Environmental Exposure Chamber
This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.
- Conditions
- Allergic Rhinitis
- Being tested
- QAV680 + Cetirizine Placebo, QAV680 + Cetirizine, Cetirizine + QAV680 Placebo, QAV680 Placebo + Cetirizine Placebo
- Keywords
- Allergic inflammation, Seasonal rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAV680 + Cetirizine PlaceboDrug
QAV680 + CetirizineDrug
Cetirizine + QAV680 PlaceboDrug
QAV680 Placebo + Cetirizine PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| QAV680 + Cetirizine Placebo | Active comparator | Not described Receives: Drug: QAV680 + Cetirizine Placebo |
| QAV680 + Cetirizine | Experimental | Not described Receives: Drug: QAV680 + Cetirizine |
| Cetirizine + QAV680 Placebo | Active comparator | Not described Receives: Drug: Cetirizine + QAV680 Placebo |
| QAV680 Placebo + Cetirizine Placebo | Placebo comparator | Not described Receives: Drug: QAV680 Placebo + Cetirizine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score measured during allergen exposure
Measured: 14 Days
Secondary outcomes (3)
Nasal airway patency assessed by acoustic rhinometry during allergen exposure
Measured: 14 days
Nasal secretion weight during allergen exposure
Measured: 14 days
Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study start22 Mar 2010
- Primary completion28 Jul 2010
- Study completion28 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103050
- Sponsor's protocol ID
- CQAV680A2204
- Status last verified
- Feb 2017
- First submitted
- 12 Apr 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT01103050
- Acronym / sponsor ID
- CQAV680A2204
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic inflammation, Seasonal rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2010 (actual)
- Primary completion
- 28 Jul 2010 (actual)
- Study completion
- 28 Jul 2010 (actual)
- First posted
- 13 Apr 2010 (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 determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QAV680 + Cetirizine Placebo | Active comparator | Drug: QAV680 + Cetirizine Placebo |
| QAV680 + Cetirizine | Experimental | Drug: QAV680 + Cetirizine |
| Cetirizine + QAV680 Placebo | Active comparator | Drug: Cetirizine + QAV680 Placebo |
| QAV680 Placebo + Cetirizine Placebo | Placebo comparator | Drug: QAV680 Placebo + Cetirizine 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)
- Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons
- positive skin prick test to ragweed allergen within twelve months of screening
Key exclusion criteria (4 listed)
- Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes)
- Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease
- Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction
- Other protocol-defined inclusion/exclusion criteria may apply
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 + Cetirizine Placebo | Drug | QAV680 + Cetirizine Placebo |
| QAV680 + Cetirizine | Drug | QAV680 + Cetirizine |
| Cetirizine + QAV680 Placebo | Drug | Cetirizine + QAV680 Placebo |
| QAV680 Placebo + Cetirizine Placebo | Drug | QAV680 Placebo + Cetirizine Placebo |
Primary outcome
Total Nasal Symptom Score measured during allergen exposure
Time frame: 14 Days
3 secondary outcomes
Nasal airway patency assessed by acoustic rhinometry during allergen exposure
Time frame: 14 days
Nasal secretion weight during allergen exposure
Time frame: 14 days
Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure
Time frame: 14 days
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 23 Feb 2017.
- Publication Link QAV680, cetirizine and their combination reduce nasal symptoms in patients with intermittent allergic rhinitis in an environmental exposure chamberLink provided by the sponsor.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
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 + Cetirizine in people with Allergic Rhinitis, run by Novartis Pharmaceuticals 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 2 inclusion and 4 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 23 Feb 2017. 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. 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 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 measured during allergen exposure (time frame: 14 Days). 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 23 Feb 2017.