Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™

NCT02249663 | Unknown Phase 3

• 1 other identifier: 71336006
• Study Type: interventional
• Target: 1,535
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.

Conditions

Seasonal Allergic Rhinitis

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS).

  Days 1 to 14

Secondary Outcomes (4)

• Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS).

  Days 1 to 14

• Change from baseline in average reflective Total Ocular Symptom Score (iTOSS).

  Days 1 to 14

• Change from baseline in average instantaneous Total Ocular Symptom Score (iTOSS).

  Days 1 to 14

• Onset of Action

  4 hours post dose

Study Arms (3)

Investigational Test Product

EXPERIMENTAL

Azelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg

Drug: Azelastine hydrochloride and Fluticasone propionate

Reference Listed Drug

ACTIVE COMPARATOR

Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg

Drug: Dymista™

Placebo

PLACEBO COMPARATOR

Placebo Nasal Spray

Other: Placebo

Interventions

Azelastine hydrochloride and Fluticasone propionate DRUG

137/50 mcg Nasal Spray

Investigational Test Product

Dymista™ DRUG

137/50 mcg Nasal Spray

Also known as: Azelastine hydrochloride and Fluticasone propionate (generic name)

Reference Listed Drug

Placebo OTHER

Nasal spray with no pharmaceutically active content

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female 12 years of age or older.
• Signed informed consent form, which meets all criteria of current FDA regulations. For patients under the age of majority in the state the study is being conducted (18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form that will be written in such a way to be understandable to a child.
• Documented positive allergic skin test, performed within the previous 12 months, to one or more of the allergens in season at the time the study is being conducted.
• A minimum of two consecutive years of previous history of Seasonal Allergic Rhinitis (SAR) to the pollen/allergen in season at the time the study is being conducted.
• Eligibility requirements for placebo lead-in period: A total (composite) score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms and total (composite) score of at least 4 on the reflective Total Ocular Symptom Score (rTOSS). These scores represent the 12 hours before the screening visit.
• In addition to requirements above, patients should have the following at the end of the placebo lead-in period and before randomization: 1) average composite score of at least 6 on the rTNSS with a minimum average score of at least 2 for "nasal congestion" and a minimum average score of at least 2 for one of the remaining 3 symptoms, and 2) average composite score of at least 4 on the rTOSS. These scores represent the 3 days of the 7 day placebo run-in period before the Randomization visit and the morning of the first day of the Randomization visit.

You may not qualify if:

• Under 12 years of age.
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• Negative or lack of documented skin allergen test (performed within the previous 12 months) to at least one of the allergens in season at the time the study is being conducted. The results of all positive skin allergen test results should be reported.
• Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis (PAR) should be excluded from the study unless the Investigator assesses that the patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic Rhinitis (SAR) rather than the chronic PAR.
• Patients who suffer only from PAR or SAR to a different allergen than that in season at the time the study is conducted.
• Previous history of less than 2 years of SAR to the pollen/allergen in season at the time the study is conducted.
• Before the placebo lead-in period, the patient has a total score of less than 6 on the rTNSS or a score less than 2 for "nasal congestion". Any patient who meets the minimum individual nasal symptom score requirements at the start of the placebo lead-in period but no longer meets the requirements prior to the randomized active treatment period of the study cannot continue in the active treatment period.
• At the end of the placebo lead-in period and before randomization, the patient has an average composite score of less than 6 on the rTNSS and an average composite score of less than 4 on the rTOSS.
• History of asthma over the previous 2 years that required chronic therapy. Occasional acute or mild exercise induced asthma will be allowable on the condition that the treatment of the attacks is restricted to beta-agonists only.
• Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa, or atrophic rhinitis.
• Clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.
• Sinus infection within the previous 30 days or history or re-occurring sinus infections.
• Patient has started immunotherapy or changed their dose of immunotherapy within 30 days of the first placebo lead-in dose or is likely to have to start immunotherapy, or change their current dose during the study.
• Treatment for oral Candidiasis within 30 days of starting the study or a current oral Candidiasis infection.
• Upper respiratory tract infection within the previous 30 days.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, 15206, United States

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

azelastine; Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Darin Brimhall, DO, FACP

  Novum Pharmaceutical Research Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darin Brimhall, DO, FACP

CONTACT

(702) 435-3739; dbrimhall@novumprs.som

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

US (1)