Back to resultsSafety and Efficacy of AL-53817 Nasal Spray Solution
Primary Purpose
Nasal Allergies, Allergies
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AL-53817 nasal spray solution
Vehicle nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Allergies focused on measuring Healthy subjects, Nasal allergies, Allergies, Environmental Exposure Chamber, EEC, Ragweed
Eligibility Criteria
Stage A Inclusion Criteria:
- Willing and able to give written informed consent.
- In good health in the opinion of an appropriately qualified physician.
- Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have a negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
- Other protocol-defined inclusion criteria may apply.
Stage B Inclusion Criteria:
- History of non-recalcitrant seasonal allergic rhinitis during the fall allergy season.
- Allergy to short ragweed allergen, defined by positive skin prick test for short ragweed allergen within the 12 months prior to Visit 1.
- Be in good health in the opinion of an appropriately qualified physician.
- Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
- Other protocol-defined inclusion criteria may apply.
Stage A Exclusion Criteria:
- Hypersensitivity to the study drug or any component of the test articles, including benzalkonium chloride.
- Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of < 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
- Current or recent history of severe, unstable, or uncontrolled conditions based upon a review of medical history and/or physical examination.
- Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
- History of HIV, hepatitis B or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
- Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
- Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
- Other protocol-defined exclusion criteria may apply.
Stage B Exclusion Criteria:
- Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
- Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of < 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
- History of HIV, hepatitis B or C or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
- Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
- Confirmed diagnosis of chronic rhinosinusitis within 12 months of Visit.
- Confirmed diagnosis of severe rhinitis or rhinosinusitis prior to Visit 1 that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Current or recent history of any severe, unstable, or uncontrolled condition that, in the opinion of the Investigator, would preclude safe participation in the study.
- Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Stage B/AL-53817
Stage B/Vehicle
Arm Description
Stage B: AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
Stage B: Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
Outcomes
Primary Outcome Measures
Number of Adverse Events in Stage A
Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Secondary Outcome Measures
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01454505
Brief Title
Safety and Efficacy of AL-53817 Nasal Spray Solution
Official Title
Safety and Efficacy of AL-53817 Nasal Spray Solution in Ragweed Sensitive Subjects in an Environmental Exposure Chamber (EEC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A) and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis (Stage B).
Detailed Description
Stage A was a 1-day, single ascending dose study utilizing 7 separate cohorts of unique subjects (healthy normal volunteers). Each cohort was administered a different dose of AL-53817 Nasal Spray Solution in order to determine the maximum tolerated dose (MTD).
In Stage B, 2 different cohorts of unique, ragweed-sensitive subjects were administered the MTD for up to 5 days twice a day to determine the safety and efficacy of AL-53817 Nasal Spray Solution for the treatment of allergic rhinitis. Subjects were required to meet minimum allergic rhinitis scores at two qualifying EEC visits to participate in the study. Subjects were continually housed in clinic during the 5-day treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Allergies, Allergies
Keywords
Healthy subjects, Nasal allergies, Allergies, Environmental Exposure Chamber, EEC, Ragweed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stage B/AL-53817
Arm Type
Experimental
Arm Description
Stage B: AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
Arm Title
Stage B/Vehicle
Arm Type
Placebo Comparator
Arm Description
Stage B: Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
Intervention Type
Drug
Intervention Name(s)
AL-53817 nasal spray solution
Intervention Description
Active ingredients administered in 1 of 3 concentrations during Stage A to determine maximum tolerated dose (MTD), and administered at maximum tolerated dose during Stage B.
Intervention Type
Other
Intervention Name(s)
Vehicle nasal spray
Intervention Description
Inactive ingredients used as placebo comparator during Stage A and Stage B.
Primary Outcome Measure Information:
Title
Number of Adverse Events in Stage A
Description
Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
Time Frame
Day 1
Title
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
Description
Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Time Frame
Baseline (pretreatment), Day 5
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
Description
Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Time Frame
Baseline (pretreatment), Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Stage A Inclusion Criteria:
Willing and able to give written informed consent.
In good health in the opinion of an appropriately qualified physician.
Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have a negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
Other protocol-defined inclusion criteria may apply.
Stage B Inclusion Criteria:
History of non-recalcitrant seasonal allergic rhinitis during the fall allergy season.
Allergy to short ragweed allergen, defined by positive skin prick test for short ragweed allergen within the 12 months prior to Visit 1.
Be in good health in the opinion of an appropriately qualified physician.
Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
Other protocol-defined inclusion criteria may apply.
Stage A Exclusion Criteria:
Hypersensitivity to the study drug or any component of the test articles, including benzalkonium chloride.
Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of < 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
Current or recent history of severe, unstable, or uncontrolled conditions based upon a review of medical history and/or physical examination.
Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
History of HIV, hepatitis B or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
Other protocol-defined exclusion criteria may apply.
Stage B Exclusion Criteria:
Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of < 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
History of HIV, hepatitis B or C or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
Confirmed diagnosis of chronic rhinosinusitis within 12 months of Visit.
Confirmed diagnosis of severe rhinitis or rhinosinusitis prior to Visit 1 that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Current or recent history of any severe, unstable, or uncontrolled condition that, in the opinion of the Investigator, would preclude safe participation in the study.
Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy of AL-53817 Nasal Spray Solution
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