Seasonal Allergic RhinitisPhase 4NCT00691665
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
A Phase 4 study testing Olopatadine HCL Nasal Spray, 0.6% and Fluticasone Propionate Nasal Spray, 50 mcg in people with Seasonal Allergic Rhinitis, run by Alcon Research at 1 site in United States.
Trial summary
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Olopatadine HCL Nasal Spray, 0.6% and Fluticasone Propionate Nasal Spray, 50 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A history of spring/summer seasonal allergies.
- Positive skin prick test for the currently prevalent allergen of the area.
- Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
- For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.
Who cannot join
- History of chronic sinusitis.
- Asthma, with the exception of intermittent asthma.
- Smokers.
- Known non-responders to antihistamines.
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
- Chronic use of long acting antihistamines.
Show all 9Show fewer
- Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
- Relatives of study site staff or other individuals who had access to the clinical study protocol.
- Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Olopatadine HCL Nasal Spray, 0.6%, Fluticasone Propionate Nasal Spray, 50 mcg
- Keywords
- Rhinitis, Seasonal Allergic Rhinitis, allergies
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine HCL Nasal Spray, 0.6%Drug
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
Fluticasone Propionate Nasal Spray, 50 mcgDrug
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Experimental | Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily Receives: Drug: Olopatadine HCL Nasal Spray, 0.6% |
| Fluticasone Propionate Nasal Spray, 50 mcg | Active comparator | Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily Receives: Drug: Fluticasone Propionate Nasal Spray, 50 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, 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 then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Measured: 14 Days minus baseline
Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline
Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, 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 then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.
Measured: 14 days minus baseline
Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.
Measured: 14 Days minus baseline
Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.
Measured: 14 Days minus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJan 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 Seasonal Allergic 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691665
- Sponsor's protocol ID
- SMA-08-06
- Status last verified
- Mar 2010
- First submitted
- 3 Jun 2008
- Last updated
- 30 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
- ClinicalTrials.gov ID
- NCT00691665
- Acronym / sponsor ID
- SMA-08-06
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Rhinitis, Seasonal Allergic Rhinitis, allergies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 10 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Experimental | Drug: Olopatadine HCL Nasal Spray, 0.6%Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily |
| Fluticasone Propionate Nasal Spray, 50 mcg | Active comparator | Drug: Fluticasone Propionate Nasal Spray, 50 mcgFluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A history of spring/summer seasonal allergies.
- Positive skin prick test for the currently prevalent allergen of the area.
- Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
- For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.
Key exclusion criteria (9 listed)
- History of chronic sinusitis.
- Asthma, with the exception of intermittent asthma.
- Smokers.
- Known non-responders to antihistamines.
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
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 Nasal Spray, 0.6%Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily | Drug | Olopatadine HCL Nasal Spray, 0.6% |
| Fluticasone Propionate Nasal Spray, 50 mcgFluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily | Drug | Fluticasone Propionate Nasal Spray, 50 mcg |
Primary outcome
Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
Time frame: 14 Days minus baseline
Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, 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 then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline
Time frame: 14 days minus baseline
Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, 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 then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.
Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
Time frame: 14 Days minus baseline
Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.
Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
Time frame: 14 Days minus baseline
Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
- 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 Nasal Spray, 0.6% and Fluticasone Propionate Nasal Spray, 50 mcg in people with Seasonal Allergic 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 4 inclusion and 9 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 30 Mar 2010. 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 Mar 2010). 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 Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline (time frame: 14 Days minus baseline). The study lists 4 primary outcomes in all. 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 30 Mar 2010.