Safety and Efficacy of AL-53817 Nasal Spray Solution

NCT01454505 | Completed Phase 1 Results

• 1 other identifier: C-10-094
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasal Allergies; Allergies

Keywords

Healthy subjects; Nasal allergies; Allergies; Environmental Exposure Chamber; EEC; Ragweed

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events in Stage A

  Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.

  Day 1

• 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.

  Baseline (pretreatment), Day 5

Secondary Outcomes (1)

• Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5

  Baseline (pretreatment), Day 5

Study Arms (2)

Stage B/AL-53817

EXPERIMENTAL

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.

Drug: AL-53817 nasal spray solution

Stage B/Vehicle

PLACEBO COMPARATOR

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.

Other: Vehicle nasal spray

Interventions

AL-53817 nasal spray solution 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/AL-53817

Vehicle nasal spray OTHER

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

Stage B/Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Terri Pasquine, Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 19, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 20, 2013
• Results First Posted: May 20, 2013

Record last verified: 2013-03

Locations

US (1)