Vasomotor RhinitisPhase 4NCT00979615
Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
A Phase 4 study testing Olopatadine HCL (Patanase) Nasal Spray, 0.6% and Azelastine HCl (Astelin) Nasal Spray, 137 mcg in people with Vasomotor Rhinitis, run by Alcon Research at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Vasomotor Rhinitis
- What is being tested?
- Olopatadine HCL (Patanase) Nasal Spray, 0.6% and Azelastine HCl (Astelin) Nasal Spray, 137 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
About this study
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).
- Conditions
- Vasomotor Rhinitis
- Being tested
- Olopatadine HCL (Patanase) Nasal Spray, 0.6%, Azelastine HCl (Astelin) Nasal Spray, 137 mcg
- Keywords
- vasomotor rhinitis, chronic non-allergic rhinitis, VMR
- Medical subject headings
- Rhinitis, Vasomotor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine HCL (Patanase) Nasal Spray, 0.6%Drug
2 sprays/ nostril BID
Azelastine HCl (Astelin) Nasal Spray, 137 mcgDrug
2 sprays/ nostril BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olopatadine HCL Nasal Spray, 0.6% Receives: Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6% |
| 2 | Active comparator | Azelastine HCl Nasal Spray, 137 mcg Receives: Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 week
Secondary outcomes (4)
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.
Measured: 2 week
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.
Measured: 2 Weeks
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.
Measured: 2 Weeks
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.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vasomotor RhinitisStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979615
- Sponsor's protocol ID
- SMA-09-03
- Status last verified
- Apr 2011
- First submitted
- 17 Sep 2009
- Last updated
- 10 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
- ClinicalTrials.gov ID
- NCT00979615
- Acronym / sponsor ID
- SMA-09-03
- Conditions
- Vasomotor Rhinitis
- Keywords
- vasomotor rhinitis, chronic non-allergic rhinitis, VMR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Posted 10 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%Olopatadine HCL Nasal Spray, 0.6% |
| 2 | Active comparator | Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcgAzelastine HCl Nasal Spray, 137 mcg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Olopatadine HCL (Patanase) Nasal Spray, 0.6%2 sprays/ nostril BID | Drug | 1 |
| Azelastine HCl (Astelin) Nasal Spray, 137 mcg2 sprays/ nostril BID | Drug | 2 |
Primary outcome
Mean Change in 2-week rTNSS From Baseline
Time frame: 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.
4 secondary outcomes
Mean Change in Rhinorrhea Reflective Score
Time frame: 2 week
Mean Change Postnasal Drip Reflective Score
Time frame: 2 Weeks
Mean Change Nasal Congestion Reflective Score
Time frame: 2 Weeks
Mean Change in Sneezing Reflective Score
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olopatadine HCL (Patanase) Nasal Spray, 0.6% and Azelastine HCl (Astelin) Nasal Spray, 137 mcg in people with Vasomotor Rhinitis, run by Alcon Research at 1 site in United States.
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 3 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 10 May 2011. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in 2-week rTNSS From Baseline (time frame: 2 week). 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 10 May 2011.