Vasomotor Rhinitis
Conditions
Keywords
vasomotor rhinitis, chronic non-allergic rhinitis, VMR
Brief summary
The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).
Interventions
DRUGOlopatadine HCL (Patanase) Nasal Spray, 0.6%
2 sprays/ nostril BID
DRUGAzelastine HCl (Astelin) Nasal Spray, 137 mcg
2 sprays/ nostril BID
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis * Negative skin tests to a panel of allergens and positive histamine test within last 2 years * History of symptoms related to defined VMR triggers
Exclusion criteria
* Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications * Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit * Chronic use of drugs that can cause rhinitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in 2-week rTNSS From Baseline | 2 week | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Rhinorrhea Reflective Score | 2 week | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. |
| Mean Change Postnasal Drip Reflective Score | 2 Weeks | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. |
| Mean Change Nasal Congestion Reflective Score | 2 Weeks | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. |
| Mean Change in Sneezing Reflective Score | 2 Weeks | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. |
Countries
United States
Participant flow
Recruitment details
September 9, 2009 - November 13, 2009
Participants by arm
| Arm | Count |
|---|---|
| Olopatadine HCL Olopatadine HCL Nasal Spray, 0.6% | 57 |
| Azelastine HCl Azelastine HCl Nasal Spray, 137 mcg | 58 |
| Total | 115 |
Baseline characteristics
| Characteristic | Olopatadine HCL | Azelastine HCl | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 54 Participants | 105 Participants |
| Sex: Female, Male Female | 39 Participants | 46 Participants | 85 Participants |
| Sex: Female, Male Male | 18 Participants | 12 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 63 | 9 / 66 |
| serious Total, serious adverse events | 0 / 63 | 0 / 66 |
Outcome results
Primary
Mean Change in 2-week rTNSS From Baseline
Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Time frame: 2 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL | Mean Change in 2-week rTNSS From Baseline | 5.9 Units on a scale | Standard Deviation 3 |
| Azelastine HCl | Mean Change in 2-week rTNSS From Baseline | 6.5 Units on a scale | Standard Deviation 2.3 |
Secondary
Mean Change in Rhinorrhea Reflective Score
Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Time frame: 2 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL | Mean Change in Rhinorrhea Reflective Score | 1.5 Units on a scale | Standard Deviation 1.1 |
| Azelastine HCl | Mean Change in Rhinorrhea Reflective Score | 1.3 Units on a scale | Standard Deviation 1 |
Secondary
Mean Change in Sneezing Reflective Score
Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL | Mean Change in Sneezing Reflective Score | 1.4 Units on a scale | Standard Deviation 0.9 |
| Azelastine HCl | Mean Change in Sneezing Reflective Score | 1.7 Units on a scale | Standard Deviation 0.8 |
Secondary
Mean Change Nasal Congestion Reflective Score
Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL | Mean Change Nasal Congestion Reflective Score | 1.4 Units on a scale | Standard Deviation 1.1 |
| Azelastine HCl | Mean Change Nasal Congestion Reflective Score | 1.7 Units on a scale | Standard Deviation 1.2 |
Secondary
Mean Change Postnasal Drip Reflective Score
Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL | Mean Change Postnasal Drip Reflective Score | 1.5 Units on a scale | Standard Deviation 1.2 |
| Azelastine HCl | Mean Change Postnasal Drip Reflective Score | 1.8 Units on a scale | Standard Deviation 0.9 |