Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00789555
Other study ID # C-08-32
Secondary ID
Status Completed
Phase Phase 4
First received November 11, 2008
Last updated January 12, 2018
Start date November 2008
Est. completion date January 2011

Study information

Verified date January 2018
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 1260
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

1. Sign informed consent;

2. Normal nasal exam;

3. History of perennial allergic rhinitis;

4. Allergy to perennial allergen documented by allergy testing;

5. Age 12 years and older;

6. Must follow instructions;

7. Must make required study visits;

8. Negative pregnancy test and adequate birth control methods for females of childbearing potential;

9. Refrain from certain allergy medications during the study;

10. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Nasal disorders;

2. Use of substances that affect the nasal septum;

3. Exposure to industrial metal plating solutions;

4. Uncontrolled, severe, or unstable diseases;

5. Hypersensitivity to the study drug or nasal spray components;

6. Relative of site staff with access to the protocol;

7. Participation in another investigational study within 30 days or at the same time as this study;

8. Medical Monitor decision;

9. Other protocol-defined exclusion criteria may apply.

Study Design


Intervention

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

Locations

Country Name City State
United States Contact Alcon Call Center For Trial Locations Fort Worth Texas

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (Day 0), Exit (Month 12 or sooner)
Primary 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." Day 30
Secondary 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. Baseline (Day 0), Exit (Month 12 or sooner)
Secondary 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. Baseline (Day 0), Exit (Month 12 or sooner)
Secondary 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. Baseline (Day 0), Exit (Month 12 or sooner)
Secondary 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. Baseline (Day 0), Exit (Month 12 or sooner)
See also
  Status Clinical Trial Phase
Completed NCT01654536 - A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR) Phase 4
Completed NCT01221285 - Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium Phase 1
Completed NCT01539304 - Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis Phase 3
Terminated NCT00491374 - Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED) Phase 4
Completed NCT00783224 - A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512) Phase 3
Completed NCT04324918 - Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis Phase 3
Completed NCT02532179 - Subcutaneous Immunotherapy for Mouse in Adults Phase 1/Phase 2
Completed NCT01451541 - A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). Phase 3
Enrolling by invitation NCT01062139 - Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy Phase 4
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT01549340 - Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022) N/A
Completed NCT01018862 - A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00261287 - Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416) Phase 3
Completed NCT00974571 - Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) Phase 3
Completed NCT04654702 - Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
Completed NCT05122143 - Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers N/A
Completed NCT01380327 - Biomarkers of Cockroach Sublingual Immunotherapy 2 Phase 1/Phase 2
Completed NCT01116778 - the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00359216 - The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726) Phase 4
Completed NCT00163514 - Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403) Phase 3