Perennial Allergic RhinitisPhase 3NCT00578331
Safety Study of Olopatadine Nasal Spray
A Phase 3 study testing Olopatadine 0.6% nasal spray in people with Perennial Allergic Rhinitis, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Olopatadine 0.6% nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 890 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jan 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
Who cannot join
- Age 11 years and younger
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Olopatadine 0.6% nasal spray, Placebo Nasal Spray
- Keywords
- rhinitis, perennial allergic rhinitis, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine 0.6% nasal sprayDrug
2 sprays each nostril twice daily
Placebo Nasal SprayDrug
2 sprays each nostril twice daily
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine 0.6% Nasal Spray | Experimental | 2 sprays each nostril twice daily Receives: Drug: Olopatadine 0.6% nasal spray |
| Placebo Nasal Spray | Placebo comparator | 2 sprays each nostril twice daily Receives: Drug: Placebo Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
Measured: day 30
Secondary outcomes (1)
Average Number of Days of Rescue Medication Taken
Measured: Month 1 through Month 12
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 startDec 2006
- Primary completionJan 2008
- Study completionJan 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.
- Other trials for Perennial 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
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Drake, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578331
- Sponsor's protocol ID
- C-05-69
- Status last verified
- Feb 2010
- First submitted
- 19 Dec 2007
- Last updated
- 31 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Olopatadine Nasal Spray
- ClinicalTrials.gov ID
- NCT00578331
- Acronym / sponsor ID
- C-05-69
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- rhinitis, perennial allergic rhinitis, allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 3 Feb 2010
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 determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Olopatadine 0.6% Nasal Spray | Experimental | Drug: Olopatadine 0.6% nasal spray2 sprays each nostril twice daily |
| Placebo Nasal Spray | Placebo comparator | Drug: Placebo Nasal Spray2 sprays each nostril twice daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
Key exclusion criteria (1 listed)
- Age 11 years and younger
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 0.6% nasal spray2 sprays each nostril twice daily | Drug | Olopatadine 0.6% Nasal Spray |
| Placebo Nasal Spray2 sprays each nostril twice daily | Drug | Placebo Nasal Spray |
Primary outcome
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
Time frame: day 30
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
1 secondary outcome
Average Number of Days of Rescue Medication Taken
Time frame: Month 1 through Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
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.
Margaret Drake study director
Alcon Research
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 0.6% nasal spray in people with Perennial 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 1 inclusion and 1 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 31 Oct 2017. 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 3 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?
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire (time frame: day 30). 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 31 Oct 2017.