Safety and Efficacy of AL-53817 Nasal Spray Solution

NCT ID: NCT01454505

Last Updated: 2013-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Nasal Allergies; Allergies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stage B/AL-53817

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.

Group Type: EXPERIMENTAL

AL-53817 nasal spray solution

Intervention Type: DRUG

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.

Stage B/Vehicle

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.

Group Type: PLACEBO_COMPARATOR

Vehicle nasal spray

Intervention Type: OTHER

Inactive ingredients used as placebo comparator during Stage A and Stage B.

Interventions

AL-53817 nasal spray solution

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: DRUG

Vehicle nasal spray

Inactive ingredients used as placebo comparator during Stage A and Stage B.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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.

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

C-10-094

Identifier Type: -

Identifier Source: org_study_id