A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis

NCT02401191 | Completed Phase 3

• 1 other identifier: FEXHYL07477
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis. Secondary Objective: To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.

Conditions

Rhinitis Allergic

Outcome Measures

Primary Outcomes (2)

• Number of adverse events (Solicited AE reporting)

  From intake of FEX60/PE10 up to approximately 2 weeks

• Changes from baseline in the nasal congestion score based on the patient's symptom diary

  After 2 weeks treatment

Secondary Outcomes (12)

• Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)

  After 2 weeks treatment

• Change in the total score of 3 nasal symptoms on a daily basis

  After 2 weeks treatment

• Change in the total score of 3 nasal symptoms during daytime

  After 2 weeks treatment

• Change in the total score of 3 nasal symptoms during night-time

  After 2 weeks treatment

• Change in the daily activity impairment score

  After 2 weeks treatment

Study Arms (1)

FEX60/PE10

EXPERIMENTAL

Internal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks

Drug: FEX60/PE10

Interventions

FEX60/PE10 DRUG

Pharmaceutical form:tablet Route of administration: oral

FEX60/PE10

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the following criteria of symptom score. (The symptom score is rated according to the 'Severity of nasal symptoms'):
• Nasal congestion score is consistently from 2 to 3 but not 4 for the last 3 days of the screening period.
• Score of sneezing or rhinorrhea is consistently 2 or 3 but not 4 throughout the last 3 days of the screening period.
• Patients aged 15 years or older, with no restriction on gender.
• Patients written informed consent.
• Females with childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug and adequate contraception during the study.

You may not qualify if:

• Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.) that could interfere with judgment of the efficacy of the investigational product (IP) and patients developing cold-like symptoms during screening period.
• Patients with severe asthma, bronchiectasis, severe hepatic, renal, or cardiac dysfunction, hematological, endocrine disease, and other serious complications.
• Patients with unstable medical conditions like diabetes mellitus, heart failure, hepatic and renal impairment.
• Patients with a history of epilepsy or with organic brain disease, which may cause epilepsy.
• Within 1 week prior to the day of registration:
• Intranasal or oral:
• Antiallergic drugs, antihistamines, anticholinergic agents, vasoconstrictor, antihistamine-containing cold remedies, agents that can be expected to have an antiallergic/antihistaminic effect (including Chinese medicines and glycyrrhizin), and other agents that are indicated for allergic symptoms (sneezing, rhinorrhea, nasal congestion, etc.).
• Agents that may affect the blood concentration of Fexofenadine (FEX) (macrolide antibiotics, azole fungicides, and preparations containing aluminum hydroxide/magnesium hydroxide).
• Within 2 weeks prior to the day of registration:
• o Steroids, immunosuppressant, and nonspecific alternative therapy (histamine-containing gamma-globulin preparations etc).
• Within 4 weeks prior to the day of registration:
• Patients receiving oral, nasal, inhaled corticosteroids.
• Depot steroid preparations.
• Patients under immunotherapy if specific immunotherapy has been started or dose changed approximately 1 month preceding enrolment in the study, (doses should maintain the same dose throughout the trial).
• Patients who are participating in another study or who have previously participated in another study within the previous 6 months prior to the day of registration.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

JP (1)