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CompletedNCT00772304Updated Mar 2, 2010Results posted

Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis

A Phase 4 interventional study of Olopatadine 0.6% / Azelastine 137 mcg in Allergic Rhinitis, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-02.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinitis

Keywords

  • rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 102 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
  2. 18 yrs of age or older
  3. Read and sign informed consent
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
  2. 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.
  3. Impairment of sense of tast or smell (self reported)
  4. Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
  5. Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
  6. Patients w/a severe impairment of nasal breathing
  7. Anatomic abnormalities of as identified by nasal examination
  8. History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
  9. History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    1

    Olopatadine 0.6% / Azelastine 137 mcg

    Drug: Olopatadine 0.6% / Azelastine 137 mcg

Interventions

  • DrugOlopatadine 0.6% / Azelastine 137 mcg

    single dose; 2 sprays per nostril

06

What researchers measure

Primary outcomes

  1. Product Preference Questionnaire for Immediate Taste

    Using a set of coded responses, subjects evaluated product preference in regards to immediate taste

    Time frame: 5 min post-dose

Secondary outcomes

  1. Taste and Aftertaste of Medication

    Time frame: 5 min, 45 min.

07

Results

Posted Feb 2, 2010
Limitations and caveats
Small sample size. The severity of symptoms experienced by patients may have masked their ability to detect taste and smell.

Participant flow

October 2008- November 2008

Participant flow — Overall Study
MilestoneOlopatadine 0.6% / Azelastine 137 Mcg
Started102
Completed102
Not completed0

Outcome measures

PrimaryProduct Preference Questionnaire for Immediate Taste

Using a set of coded responses, subjects evaluated product preference in regards to immediate taste

Time frame:
5 min post-dose
Reported as:
Number · Percentage of participants
Product Preference Questionnaire for Immediate Taste
Percentage of participantsOlopatadine 0.6% / Azelastine 137 Mcg
Preferred Azelastine Strongly26.47
Preferred Azelastine Somewhat10.78
Preferred Azelastine Slightly5.88
Same15.69
Preferred Olopatadine Slightly8.82
Preferred Olopatadine Somewhat8.82
Preferred Olopatadine Strongly23.53
SecondaryTaste and Aftertaste of Medication
Time frame:
5 min, 45 min.

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Olopatadine 0.6% / Azelastine 137 Mcg—0/102 (0%)0/102 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Olopatadine 0.6% / Azelastine 137 Mcg
<=18 years0
Between 18 and 65 years101
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Olopatadine 0.6% / Azelastine 137 Mcg
Female74
Male28
08

Study locations

1 site
  • Alcon Call Center for Trial Locations
    Fort Worth, Texas 76134, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00772304
Lead sponsor
Alcon Research
First posted
Oct 15, 2008
Start date
Oct 2008
Primary completion
Nov 2008
Results posted
Feb 2, 2010
Last update
Mar 2, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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