Perennial Allergic RhinitisPhase 4NCT00789555

Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

A Phase 4 study testing Olopatadine hydrochloride 0.6% nasal spray (PATANASE) in people with Perennial Allergic Rhinitis, run by Alcon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR). 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 hydrochloride 0.6% nasal spray (PATANASE)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,260 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Jan 2011
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Sign informed consent;
Normal nasal exam;
History of perennial allergic rhinitis;
Allergy to perennial allergen documented by allergy testing;
Age 12 years and older;
Must follow instructions;

Show all 10Show fewer

Must make required study visits;
Negative pregnancy test and adequate birth control methods for females of childbearing potential;
Refrain from certain allergy medications during the study;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Nasal disorders;
Use of substances that affect the nasal septum;
Exposure to industrial metal plating solutions;
Uncontrolled, severe, or unstable diseases;
Hypersensitivity to the study drug or nasal spray components;
Relative of site staff with access to the protocol;

Show all 9Show fewer

Participation in another investigational study within 30 days or at the same time as this study;
Medical Monitor decision;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis

Conditions: Perennial Allergic Rhinitis
Being tested: Olopatadine hydrochloride 0.6% nasal spray (PATANASE), Olopatadine nasal spray vehicle, pH 3.7, Olopatadine nasal spray vehicle, pH 7.0
Keywords: nasal allergy, nasal spray, seasonal allergy, perennial allergy
Medical subject headings: Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olopatadine hydrochloride 0.6% nasal spray (PATANASE)Drug
Also called PATANASE®
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 3.7Other
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 7.0Other
Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Study groups in NCT00789555
Study group	Role	What they receive
PATANASE	Experimental	Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months Receives: Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
Patanase Vehicle, pH 3.7	Placebo comparator	Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months Receives: Other: Olopatadine nasal spray vehicle, pH 3.7
Patanase Vehicle, pH 7.0	Placebo comparator	Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months Receives: Other: Olopatadine nasal spray vehicle, pH 7.0

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.
Measured: Baseline (Day 0), Exit (Month 12 or sooner)
Self-Rated Relief Assessment at Day 30
Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: "I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."
Measured: Day 30

Secondary outcomes (4)

Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)
Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes.
Measured: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)
Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure.
Measured: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)
Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure.
Measured: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.
Measured: Baseline (Day 0), Exit (Month 12 or sooner)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Jan 2011

First posted13 Nov 2008 (estimated)
Study startNov 2008
Primary completionJan 2011
Study completionJan 2011

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789555
Sponsor's protocol ID: C-08-32
Status last verified: Jan 2018
First submitted: 11 Nov 2008
Last updated: 8 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Perennial Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
ClinicalTrials.gov ID: NCT00789555
Acronym / sponsor ID: C-08-32
Conditions: Perennial Allergic Rhinitis
Keywords: nasal allergy, nasal spray, seasonal allergy, perennial allergy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,260 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 13 Nov 2008 (estimated)
Results: Posted 7 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
PATANASE	Experimental	Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE)Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months
Patanase Vehicle, pH 3.7	Placebo comparator	Other: Olopatadine nasal spray vehicle, pH 3.7Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Patanase Vehicle, pH 7.0	Placebo comparator	Other: Olopatadine nasal spray vehicle, pH 7.0Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

Sign informed consent;
Normal nasal exam;
History of perennial allergic rhinitis;
Allergy to perennial allergen documented by allergy testing;
Age 12 years and older;

Key exclusion criteria (9 listed)

Nasal disorders;
Use of substances that affect the nasal septum;
Exposure to industrial metal plating solutions;
Uncontrolled, severe, or unstable diseases;
Hypersensitivity to the study drug or nasal spray components;

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 0.6% nasal spray (PATANASE)Also: PATANASE®Two sprays in each nostril twice a day (morning and evening) for up to 12 months	Drug	PATANASE
Olopatadine nasal spray vehicle, pH 3.7Two sprays in each nostril twice a day (morning and evening) for up to 12 months	Other	Patanase Vehicle, pH 3.7
Olopatadine nasal spray vehicle, pH 7.0Two sprays in each nostril twice a day (morning and evening) for up to 12 months	Other	Patanase Vehicle, pH 7.0

Primary outcome

Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.
Self-Rated Relief Assessment at Day 30
Time frame: Day 30
Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: "I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."

4 secondary outcomes

Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)

Results and safety

Results posted to the registry on 7 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PATANASE	421	262
Patanase Vehicle, pH 3.7	417	278
Patanase Vehicle, pH 7.0	422	263

Primary outcome: Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)

Time frame: Baseline (Day 0), Exit (Month 12 or sooner). Number. Unit: Percentage of subjects

Measure	PATANASE n = 386	Patanase Vehicle, pH 3.7 n = 386	Patanase Vehicle, pH 7.0 n = 381
Anatomic Abnormalities	0.8	1.3	0.3
Bleeding	0.8	1.0	2.6
Infection	0.3	1.0	0.0
Possible Ulcerations	0.5	0.5	1.6

Population analysed: This analysis population includes all subjects who received study drug (Safety Analysis Set), minus any missing data.

Primary outcome: Self-Rated Relief Assessment at Day 30

Time frame: Day 30. Mean (Standard Deviation). Unit: Units on a scale

Measure	PATANASE n = 328	Patanase Vehicle, pH 3.7 n = 331	Patanase Vehicle, pH 7.0 n = 330
Value	2.4 (0.9)	2.7 (1.0)	2.7 (0.9)

Population analysed: Analysis population included all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT). The LOCF (last observation carried forward method) was used to impute missing data.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 2 years, 1 month, 16 days. Adverse events were defined as any untoward (unfavorable and unintended) medical occurrence in a subject administered a test article.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PATANASE	8 of 421 (1.9%)	220 of 421 (52.3%)	Not reported
Patanase Vehicle, pH 3.7	7 of 417 (1.7%)	213 of 417 (51.1%)	Not reported
Patanase Vehicle, pH 7.0	14 of 422 (3.3%)	214 of 422 (50.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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.

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 hydrochloride 0.6% nasal spray (PATANASE) 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 10 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 8 Feb 2018. 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 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 7 Sep 2012). 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?

Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) (time frame: Baseline (Day 0), Exit (Month 12 or sooner)). The study lists 2 primary outcomes in all. 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 NCT00789555.

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 8 Feb 2018.