Seasonal Allergic RhinitisPhase 3NCT00578929
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
A Phase 3 study testing Olopatadine Hydrochloride Nasal Spray 0.6% in people with Seasonal Allergic Rhinitis, run by Alcon Research at 1 site in United States.
Trial summary
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Olopatadine Hydrochloride Nasal Spray 0.6%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,388 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 3
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female; minimum of 6 years of age and less than 12 years
- 2 year history of seasonal allergic rhinitis
Who cannot join
- Concurrent disease that might interfere with the investigation or evaluation of te study medication
- Confirmed diagnosis of chronic rhinosinusitis within the last year
- Asthma, with the exception of mild intermittent asthma
- Anatomical nasal deformity
- Nasal obstruction
- Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
- Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
- Ocular disorder other that allergic conjunctivitis
Trial locations and contacts
1 site in 1 country.
About this study
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Olopatadine Hydrochloride Nasal Spray 0.6%, Vehicle
- Keywords
- allergic rhinitis, allergies, seasonal allergies
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine Hydrochloride Nasal Spray 0.6%Drug
Olopatadine HCl 1 or 2 sprays per nostril twice daily
VehicleDrug
Vehicle 1 or 2 sprays per nostril twice daily
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine 0.6% 1 Spray | Experimental | Olopatadine HCl 0.6% 1 spray per nostril twice daily Receives: Drug: Olopatadine Hydrochloride Nasal Spray 0.6% |
| Vehicle 1 spray | Placebo comparator | Vehicle 1 spray per nostril twice daily Receives: Drug: Vehicle |
| Olopatadine 0.6% 2 sprays | Experimental | Olopatadine HCl 0.6% 2 sprays per nostril twice daily Receives: Drug: Olopatadine Hydrochloride Nasal Spray 0.6% |
| Vehicle 2 sprays | Placebo comparator | Vehicle 2 sprays per nostril twice daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.
The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
Measured: Baseline through 2 weeks after randomization
Secondary outcomes (1)
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.
The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days.
Measured: Baseline through 2 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ed Tumaian, Study director, ed.tumaian@alconlabs.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578929
- Sponsor's protocol ID
- C-07-01
- Status last verified
- Feb 2010
- First submitted
- 19 Dec 2007
- Last updated
- 2 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meltzer EO, Blaiss M, Fairchild CJ. Comprehensive report of olopatadine 0.6% nasal spray as treatment for children with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 May-Jun;32(3):213-20. doi: 10.2500/aap.2011.32.3448. Epub 2011 Apr 8.
PubMed 21477426
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
- ClinicalTrials.gov ID
- NCT00578929
- Acronym / sponsor ID
- C-07-01
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- allergic rhinitis, allergies, seasonal allergies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,388 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 9 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Olopatadine 0.6% 1 Spray | Experimental | Drug: Olopatadine Hydrochloride Nasal Spray 0.6%Olopatadine HCl 0.6% 1 spray per nostril twice daily |
| Vehicle 1 spray | Placebo comparator | Drug: VehicleVehicle 1 spray per nostril twice daily |
| Olopatadine 0.6% 2 sprays | Experimental | Drug: Olopatadine Hydrochloride Nasal Spray 0.6%Olopatadine HCl 0.6% 2 sprays per nostril twice daily |
| Vehicle 2 sprays | Placebo comparator | Drug: VehicleVehicle 2 sprays per nostril twice daily |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female; minimum of 6 years of age and less than 12 years
- 2 year history of seasonal allergic rhinitis
Key exclusion criteria (8 listed)
- Concurrent disease that might interfere with the investigation or evaluation of te study medication
- Confirmed diagnosis of chronic rhinosinusitis within the last year
- Asthma, with the exception of mild intermittent asthma
- Anatomical nasal deformity
- Nasal obstruction
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 Hydrochloride Nasal Spray 0.6%Olopatadine HCl 1 or 2 sprays per nostril twice daily | Drug | Olopatadine 0.6% 1 Spray, Olopatadine 0.6% 2 sprays |
| VehicleVehicle 1 or 2 sprays per nostril twice daily | Drug | Vehicle 1 spray, Vehicle 2 sprays |
Primary outcome
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
Time frame: Baseline through 2 weeks after randomization
Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
1 secondary outcome
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
Time frame: Baseline through 2 weeks after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21477426Meltzer EO, Blaiss M, Fairchild CJ. Comprehensive report of olopatadine 0.6% nasal spray as treatment for children with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 May-Jun;32(3):213-20. doi: 10.2500/aap.2011.32.3448. Epub 2011 Apr 8.
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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.
Ed Tumaian study director
ed.tumaian@alconlabs.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olopatadine Hydrochloride Nasal Spray 0.6% 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 2 inclusion and 8 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 2 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 Feb 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?
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) (time frame: Baseline through 2 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578929, which also lists 1 linked publication.
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 2 Mar 2010.