Allergic RhinitisPhase 2NCT01804400
A Clinical Trial to Test How Well Two Drugs, QAW039 and Montelukast Work Both Individually and Together, to Target Allergic Rhinitis Using an Environmental Exposure Chamber
A Phase 2 study testing QAW039 and Montelukast in people with Allergic Rhinitis, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
This study will assess the safety and efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber. 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?
- QAW039 and Montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Oct 2013
- 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
- Male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two grass pollen allergy seasons.
- A positive skin prick test at Visit 1 to dactylis glomerata with a wheal diameter equal to or greater than 3 mm and a negative control with a wheal diameter of zero. A positive skin prick test within 12 months prior to Visit 1 is also acceptable.
- FEV1 measured by spirometry must be ≥80% of their predicted value at screening. If the patient does not achieve ≥80% of their predicted value this may be repeated prior to the EEC challenge at visit 2.
- TNSS score ≥6 on at least one assessment during the 2h EEC challenge at Screening.
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- Pregnant or nursing (lactating) women,
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Three-period Incomplete Cross Over Study to Compare the Efficacy of QAW039 Alone and in Combination With Montelukast in Patients With Allergic Rhinitis Using an Environmental Exposure Chamber
This study will assess the safety and efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber.
- Conditions
- Allergic Rhinitis
- Being tested
- QAW039, Montelukast, 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.
QAW039Drug
MontelukastDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| QAW039 + Montelukast | Experimental | Not described Receives: Drug: QAW039; Drug: Montelukast; Drug: Placebo |
| QAW039 Once a day (q.d.) | Experimental | Not described Receives: Drug: QAW039; Drug: Placebo |
| QAW039 Twice a day (b.i.d.) | Experimental | Not described Receives: Drug: QAW039; Drug: Placebo |
| Montelukast | Active comparator | Not described Receives: Drug: Montelukast; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score from baseline at 14 days
Total Nasal Symptom Score (TNSS) averaged over the last two hours (2-4h) of exposure following 14 days treatment with QAW039 and/or Montelukast or matched placebo
Measured: Baseline, Day 14
Secondary outcomes (11)
Change in Total Ocular Symptom score from Baseline at 14 days
Total Ocular Symptom Score (TOSS), defined as the sum of ocular symptoms of eye tearing, itching, watery eyes and redness, each of which is scored on a scale from 0 and 3
Measured: Baseline, Day 14
Change in Nasal Flow from baseline at 14 days
Measured using rhinomanometry Flow rates at 150 Pa will be obtained separately for the right and left nostrils (cm^3/second). The sum of the flow rates of both nostrils will be calculated from the two measurements
Measured: Prior to, and every 60 min during allergen exposure period
Change in Nasal excretion weight from baseline at 14 days
Total weight of tissues (before and after use)
Measured: Baseline, Day 14
Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days
Change in FEV1 from Baseline
Measured: Baseline, Day 14
Change in Forced Vital Capacity (FVC) from baseline at 14 days
Change in FVC from Baseline
Measured: Baseline, Day 14
Change in FEV1/FVC at from baseline at 14 days
Change in FEV1/FVC from Baseline
Measured: Baseline, Day 14
Plasma Concentration maximum (Cmax)
Determined at steady state in plasma
Measured: Day 1-14
Plasma Concentration Minimum (Cmin)
Determined at steady state in plasma
Measured: Day 1-14
Plasma Concentration Average (Cav)
Determined at steady state in plasma
Measured: Day 1-14
Time of Cmax (Tmax)
Determined at steady state in plasma
Measured: Day 1-14
Area Under Curve (AUCtau)
Determined at steady state in plasma
Measured: Day 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 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
- NCT01804400
- Sponsor's protocol ID
- CQAW039A2212
- Other IDs
- 2012-001389-14
- Status last verified
- Nov 2016
- First submitted
- 4 Oct 2012
- 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, Double-blind, Placebo-controlled Three-period Incomplete Cross Over Study to Compare the Efficacy of QAW039 Alone and in Combination With Montelukast in Patients With Allergic Rhinitis Using an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT01804400
- Acronym / sponsor ID
- CQAW039A2212
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Mar 2013 (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 assess the safety and efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| QAW039 + Montelukast | Experimental | Drug: QAW039, Drug: Montelukast, Drug: Placebo |
| QAW039 Once a day (q.d.) | Experimental | Drug: QAW039, Drug: Placebo |
| QAW039 Twice a day (b.i.d.) | Experimental | Drug: QAW039, Drug: Placebo |
| Montelukast | Active comparator | Drug: Montelukast, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two grass pollen allergy seasons.
- A positive skin prick test at Visit 1 to dactylis glomerata with a wheal diameter equal to or greater than 3 mm and a negative control with a wheal diameter of zero. A positive skin prick test within 12 months prior to Visit 1 is also acceptable.
- FEV1 measured by spirometry must be ≥80% of their predicted value at screening. If the patient does not achieve ≥80% of their predicted value this may be repeated prior to the EEC challenge at visit 2.
- TNSS score ≥6 on at least one assessment during the 2h EEC challenge at Screening.
Key exclusion criteria (3 listed)
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- Pregnant or nursing (lactating) women,
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
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 |
|---|---|---|
| QAW039 | Drug | QAW039 + Montelukast, QAW039 Once a day (q.d.), QAW039 Twice a day (b.i.d.) |
| Montelukast | Drug | Montelukast, QAW039 + Montelukast |
| Placebo | Drug | Montelukast, Placebo, QAW039 + Montelukast, QAW039 Once a day (q.d.), QAW039 Twice a day (b.i.d.) |
Primary outcome
Change in Total Nasal Symptom Score from baseline at 14 days
Time frame: Baseline, Day 14
Total Nasal Symptom Score (TNSS) averaged over the last two hours (2-4h) of exposure following 14 days treatment with QAW039 and/or Montelukast or matched placebo
11 secondary outcomes
Change in Total Ocular Symptom score from Baseline at 14 days
Time frame: Baseline, Day 14
Change in Nasal Flow from baseline at 14 days
Time frame: Prior to, and every 60 min during allergen exposure period
Change in Nasal excretion weight from baseline at 14 days
Time frame: Baseline, Day 14
Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days
Time frame: Baseline, Day 14
Change in Forced Vital Capacity (FVC) from baseline at 14 days
Time frame: Baseline, Day 14
Change in FEV1/FVC at from baseline at 14 days
Time frame: Baseline, Day 14
Plasma Concentration maximum (Cmax)
Time frame: Day 1-14
Plasma Concentration Minimum (Cmin)
Time frame: Day 1-14
Plasma Concentration Average (Cav)
Time frame: Day 1-14
Time of Cmax (Tmax)
Time frame: Day 1-14
Area Under Curve (AUCtau)
Time frame: Day 1-14
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 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 QAW039 and Montelukast in people with Allergic Rhinitis, run by Novartis Pharmaceuticals at 1 site in Germany.
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 4 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 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 Germany. 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?
Change in Total Nasal Symptom Score from baseline at 14 days (time frame: Baseline, Day 14). 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.