Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis

NCT02402465 | Completed Phase 4 Results

• 1 other identifier: IRB14-1199
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Dymista, a combined product containing the antihistamine azelastine and the intranasal steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of efficacy not only occurs at the initiation of treatment, but persists for its duration. The mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on examining the effects of Dymista on the dynamics of the allergic response in man using nasal provocation with antigen. The investigators will study the relationship between symptoms, physiology, cells and mediators.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Response in Albumin Levels in Nasal Lavage Following Each Challenge

  Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (albumin amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).

  3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.

Secondary Outcomes (1)

• Sneezes After Allergen Challenge

  3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.

Other Outcomes (6)

• Total Nasal Symptom Score

  3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.

• Change From Baseline Response in Lactoferrin Levels in Nasal Lavage Following Each Challenge

  3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.

• Eosinophils

  3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo nasal spray that is similar to Dymista in all respects except the active ingredient

Drug: Placebo; Procedure: Nasal Allergen Challenge

Fluticasone propionate

EXPERIMENTAL

Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista

Drug: Fluticasone propionate; Procedure: Nasal Allergen Challenge

Dymista (fluticasone/azelastine)

EXPERIMENTAL

Dymista is also provided as a nasal spray in bottles similar to the other two agents

Drug: Fluticasone/Azelastine nasal spray; Procedure: Nasal Allergen Challenge

Interventions

Placebo DRUG

Patients will be treated by placebo

Also known as: saline

Placebo

Fluticasone propionate DRUG

Patients will receive fluticasone nasal spray

Also known as: Flonase

Fluticasone propionate

Fluticasone/Azelastine nasal spray DRUG

Patients will receive Dymista nasal spray

Also known as: Dymista

Dymista (fluticasone/azelastine)

Nasal Allergen Challenge PROCEDURE

All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration

Also known as: Nasal provocation

Dymista (fluticasone/azelastine); Fluticasone propionate; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females between 18 and 55 years of age.
• History of grass and/or ragweed allergic rhinitis.
• Positive skin test to grass and/or ragweed antigen.
• Positive response to screening nasal challenge.
• Off all anti-allergic medications for a minimum of 2 weeks.

You may not qualify if:

• Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
• Pregnant or lactating women.
• Upper respiratory infection within 14 days of study start.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sodium Chloride; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Fuad Baroody, MD
• Organization: University of Chicago

fbaroody@surgery.bsd.uchicago.edu

773-702-4790

Study Officials

• Fuad M Baroody, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 30, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: February 1, 2020
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-02

Locations

US (1)