Trial · NCT01804400
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
NCT01804400, Phase 2, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT01804400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01804400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01804400
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 188 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Allergic Rhinitis
- Interventions
- QAW039, Montelukast, Placebo
- First posted
- 2013-03-05
- Last updated
- 2016-11-18
- Other registries' IDs
- eudract:2012-001389-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Nasal Symptom Score from baseline at 14 days | 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 |
| Secondary | Change in Total Ocular Symptom score from Baseline at 14 days | Baseline, Day 14 | 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 |
| Secondary | Change in Nasal Flow from baseline at 14 days | Prior to, and every 60 min during allergen exposure period | 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 |
| Secondary | Change in Nasal excretion weight from baseline at 14 days | Baseline, Day 14 | Total weight of tissues (before and after use) |
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days | Baseline, Day 14 | Change in FEV1 from Baseline |
| Secondary | Change in Forced Vital Capacity (FVC) from baseline at 14 days | Baseline, Day 14 | Change in FVC from Baseline |
| Secondary | Change in FEV1/FVC at from baseline at 14 days | Baseline, Day 14 | Change in FEV1/FVC from Baseline |
| Secondary | Plasma Concentration maximum (Cmax) | Day 1-14 | Determined at steady state in plasma |
| Secondary | Plasma Concentration Minimum (Cmin) | Day 1-14 | Determined at steady state in plasma |
| Secondary | Plasma Concentration Average (Cav) | Day 1-14 | Determined at steady state in plasma |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01804400
GET https://conductscience.org/api/trials/v1/NCT01804400/registered