Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

• ClinicalTrials.gov Identifier: NCT00789555
• Recruitment Status: Completed
• First Posted: November 13, 2008
• Results First Posted: September 7, 2012
• Last Update Posted: February 8, 2018
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Perennial Allergic Rhinitis	Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE); Other: Olopatadine nasal spray vehicle, pH 3.7; Other: Olopatadine nasal spray vehicle, pH 7.0	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
• Study Start Date: November 2008
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: PATANASE; Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months	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 Name: PATANASE®
Placebo Comparator: Patanase Vehicle, pH 3.7; Olopatadine nasal spray vehicle, pH 3.7, 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
Placebo Comparator: Patanase Vehicle, pH 7.0; Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months	Other: Olopatadine nasal spray vehicle, pH 7.0; Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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."

Secondary Outcome Measures :

1. 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 in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes.
2. 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 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.
3. 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 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.
4. 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) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Texas

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00789555
• Other Study ID Numbers: C-08-32
• First Posted: November 13, 2008
• Results First Posted: September 7, 2012
• Last Update Posted: February 8, 2018
• Last Verified: January 2018

Keywords provided by Alcon Research:

nasal allergy; nasal spray; seasonal allergy; perennial allergy

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Olopatadine Hydrochloride; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action