Allergic RhinitisPhase 4NCT00772304
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
A Phase 4 study testing Olopatadine 0.6% / Azelastine 137 mcg in people with Allergic Rhinitis, run by Alcon Research at 1 site in United States.
Trial summary
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Olopatadine 0.6% / Azelastine 137 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
- 18 yrs of age or older
- Read and sign informed consent
- Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.
Who cannot join
- History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
- Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection.
- Impairment of sense of tast or smell (self reported)
- Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
- Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
- Patients w/a severe impairment of nasal breathing
Show all 9Show fewer
- Anatomic abnormalities of as identified by nasal examination
- History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
- History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- Olopatadine 0.6% / Azelastine 137 mcg
- Keywords
- rhinitis
- Medical subject headings
- Rhinitis, Allergic, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine 0.6% / Azelastine 137 mcgDrug
single dose; 2 sprays per nostril
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olopatadine 0.6% / Azelastine 137 mcg Receives: Drug: Olopatadine 0.6% / Azelastine 137 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Preference Questionnaire for Immediate Taste
Using a set of coded responses, subjects evaluated product preference in regards to immediate taste
Measured: 5 min post-dose
Secondary outcomes (1)
Taste and Aftertaste of Medication
Measured: 5 min, 45 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2008
- 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.
- Other trials for 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772304
- Sponsor's protocol ID
- SMA-08-21
- Status last verified
- Feb 2010
- First submitted
- 13 Oct 2008
- Last updated
- 2 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 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00772304
- Acronym / sponsor ID
- SMA-08-21
- Conditions
- Allergic Rhinitis
- Keywords
- rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 2 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Olopatadine 0.6% / Azelastine 137 mcgOlopatadine 0.6% / Azelastine 137 mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
- 18 yrs of age or older
- Read and sign informed consent
- Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.
Key exclusion criteria (9 listed)
- History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
- Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection.
- Impairment of sense of tast or smell (self reported)
- Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
- Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
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% / Azelastine 137 mcgsingle dose; 2 sprays per nostril | Drug | 1 |
Primary outcome
Product Preference Questionnaire for Immediate Taste
Time frame: 5 min post-dose
Using a set of coded responses, subjects evaluated product preference in regards to immediate taste
1 secondary outcome
Taste and Aftertaste of Medication
Time frame: 5 min, 45 min.
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.
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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 0.6% / Azelastine 137 mcg in people with 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 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. 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 2 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?
Product Preference Questionnaire for Immediate Taste (time frame: 5 min post-dose). 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 2 Mar 2010.