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Trial · NCT03290248

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0Baseline to Day 28Population included subjects from Part 1 of the study and those who had received at least one dose of study medication.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.score on a scale*hoursMEAN
SECONDARYSubjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSubjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSubjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSubjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDChange in Peak Nasal Inspiratory Flow (PNIF)
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.L*Hr/minMEAN
OTHER_PRE_SPECIFIEDNasal Inflammation Score Using Otoscope
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDIntranasal Nitric Oxide Levels
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Population includes only patients from Part 2 of the study.ppbMEAN
OTHER_PRE_SPECIFIEDChange in Cytokine Concentration in Nasal Cavity and Blood
Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
Data was not collected for this exploratory endpoint.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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