Allergic RhinitisPhase 2NCT00794144
Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
A Phase 2 study testing Olopatadine Hydrochloride Nasal Spray 0.6% in people with Allergic Rhinitis, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Olopatadine Hydrochloride Nasal Spray 0.6%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2008
- Phase
- Phase 2
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient must be at least 2 years of age and less than 6 years of age on Day 1;
- Parent/legal guardian must be willing and able to give written informed consent and must provide this consent for the study;
- Patient must have a positive case history of allergic rhinitis symptoms and at least one documented positive skin test within the 5 years prior to Day 1 of the following type: skin prick test, intradermal test or RAST test(radioallergosorbent test) for an allergen (≥ 3 mm wheal greater than diluent after skin prick testing; ≥ 7 mm wheal greater than the diluent after intradermal testing; or positive level 2 or greater after RAST testing);
- Patient and parent/caregiver must be willing and able to make required study visits;
- Patient and parent/caregiver must be able to follow instructions;
- Nasal exam must confirm absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations at Screening and prior to administration of test article at the Day 1 Visit. A finding of 'present' for any of these parameters disqualifies the patient from the study, regardless of clinical relevance.
Who cannot join
- The need for chronic or intermittent use of any prescription or over-the-counter nasal spray during the study period;
- Use of any form of olopatadine (e.g., PATANOL®, PATADAY™, PATANASE®) within 7 days of Day 1;
- Current or recent (within the last 14 days) use of any drugs/drug classes or combinations thereof that may prolong the QT interval;
- Patients with a history or evidence of nasolacrimal drainage system malfunction or abnormality that may interfere with the results of the study;
- Concurrent disease that might complicate or interfere with the investigation or evaluation of the study medications (such as rhinitis medicamentosa or large obstructive nasal polyps);
- Patients with syndromes associated with midfacial deformities or other anatomic nasal deformity that may interfere with the patient's participation in the study, as identified by physical or nasal examination at Screening or Day 1;
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- Diagnosis of acute sinusitis within 30 days of Day 1 or diagnosis of chronic rhinosinusitis within one year of Day 1;
- Congestion that would, in the opinion of the investigator, interfere with successful nasal drug administration/absorption (in either nostril);
- Upper or lower respiratory infection within 14 days of Day 1;
- Asthma, with the exception of intermittent asthma as outlined in Section 18.5, from the Stepwise Approach for Managing Asthma in Children 0-4 Years of Age, and Stepwise Approach for Managing Asthma in Children 5-11 Years of Age (5);
- Current or recent (< 6 months) history of severe, unstable, or uncontrolled neurological, cardiovascular, gastrointestinal, hematological, hepatic, and/or renal disease, or evidence of other diseases at the physical examination conducted at the Screening Visit, which in the opinion of the Investigator would preclude the safe participation of the patient in the study;
- Hypersensitivity to olopatadine, benzalkonium chloride, or any component of the test articles;
- History or current infection of HIV (Human Immunodeficiency Virus), hepatitis B or C or A, as indicated by the patient's parent or legal guardian response on the HIV/Hepatitis survey;
- Relatives of study site staff or other individuals who would have access to the clinical study protocol;
- A family member or any individual residing in the same household of a patient that is currently enrolled in the study;
- Participation in any other investigational study within 30 days before entry into this study (Day 1), or concomitantly with this study;
- Clinically relevant abnormal vital signs (pulse rate, average systolic and diastolic blood pressure) at Screening or Day 1. The ranges below have been designated as normal for the study. Inclusion of patients with values outside of these normal ranges is at the discretion of the study investigator;
- Normal Cardiovascular Ranges
- Systolic Blood Pressure - 86 to 116 mmHg (millimeters mercury)
- Diastolic Blood Pressure -50 to 78 mmHg
- Pulse - 75 to 130 bpm (beats per minute)
- In addition, the Alcon Medical Monitor and/or Principal Investigator may declare any patient ineligible for the study based upon sound medical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
- Conditions
- Allergic Rhinitis
- Being tested
- Olopatadine Hydrochloride Nasal Spray 0.6%, Olopatadine Hydrochloride Nasal Spray Vehicle
- Keywords
- Allergic Rhinitis, Pediatric, PATANASE
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine Hydrochloride Nasal Spray 0.6%Drug
one spray in each nostril twice daily for 2 weeks
Olopatadine Hydrochloride Nasal Spray VehicleDrug
one spray in each nostril twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olopatadine Hydrochloride Nasal Spray 0.6% Receives: Drug: Olopatadine Hydrochloride Nasal Spray 0.6% |
| 2 | Placebo comparator | Olopatadine Hydrochloride Nasal Spray Vehicle Receives: Drug: Olopatadine Hydrochloride Nasal Spray Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Anatomic Nasal Exam Abnormalities
The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa
Measured: Day 1 (Baseline) to Exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Niran Amar, MD, Principal investigatorSheri Byrd, MD, Principal investigator, Spartanburg Medical CenterAlbert Finn, MD, Principal investigator, National Allergy, Asthma, & UrticariaJoseph Flanagan, MD, Principal investigator, Health Sciences Research CenterBrad H Goodman, MD, Principal investigator, Aeroallergy Research LaboratoriesFrank Hampel, MD, Principal investigator, Central Texas Allergy and AsthmaYu-Luen Hsu, MD, Principal investigator, West Coast Clinical Trials Phase 2-4Neil Kao, MD, Principal investigator, Allergic Disease and Asthma Cente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794144
- Sponsor's protocol ID
- C-07-02
- Status last verified
- Feb 2010
- First submitted
- 17 Nov 2008
- Last updated
- 4 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 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
- ClinicalTrials.gov ID
- NCT00794144
- Acronym / sponsor ID
- C-07-02
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Pediatric, PATANASE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Posted 4 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Olopatadine Hydrochloride Nasal Spray 0.6%Olopatadine Hydrochloride Nasal Spray 0.6% |
| 2 | Placebo comparator | Drug: Olopatadine Hydrochloride Nasal Spray VehicleOlopatadine Hydrochloride Nasal Spray Vehicle |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patient must be at least 2 years of age and less than 6 years of age on Day 1;
- Parent/legal guardian must be willing and able to give written informed consent and must provide this consent for the study;
- Patient must have a positive case history of allergic rhinitis symptoms and at least one documented positive skin test within the 5 years prior to Day 1 of the following type: skin prick test, intradermal test or RAST test(radioallergosorbent test) for an allergen (≥ 3 mm wheal greater than diluent after skin prick testing; ≥ 7 mm wheal greater than the diluent after intradermal testing; or positive level 2 or greater after RAST testing);
- Patient and parent/caregiver must be willing and able to make required study visits;
- Patient and parent/caregiver must be able to follow instructions;
Key exclusion criteria (22 listed)
- The need for chronic or intermittent use of any prescription or over-the-counter nasal spray during the study period;
- Use of any form of olopatadine (e.g., PATANOL®, PATADAY™, PATANASE®) within 7 days of Day 1;
- Current or recent (within the last 14 days) use of any drugs/drug classes or combinations thereof that may prolong the QT interval;
- Patients with a history or evidence of nasolacrimal drainage system malfunction or abnormality that may interfere with the results of the study;
- Concurrent disease that might complicate or interfere with the investigation or evaluation of the study medications (such as rhinitis medicamentosa or large obstructive nasal polyps);
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 Nasal Spray 0.6%one spray in each nostril twice daily for 2 weeks | Drug | 1 |
| Olopatadine Hydrochloride Nasal Spray Vehicleone spray in each nostril twice daily for 2 weeks | Drug | 2 |
Primary outcome
Number of Participants With Anatomic Nasal Exam Abnormalities
Time frame: Day 1 (Baseline) to Exit
The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
Niran Amar, MD principal investigator
Sheri Byrd, MD principal investigator
Spartanburg Medical Center
Albert Finn, MD principal investigator
National Allergy, Asthma, & Urticaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olopatadine Hydrochloride Nasal Spray 0.6% 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 6 inclusion and 22 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 4 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 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?
Number of Participants With Anatomic Nasal Exam Abnormalities (time frame: Day 1 (Baseline) to Exit). 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 4 Mar 2010.