Evaluation of Efficacy of Dellegra in Exposure Unit

NCT02175485 | Completed Phase 4

• 2 other identifiers: FEXHYL06934U1111-1152-0373
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure. Secondary Objective: To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.

Conditions

Rhinitis Allergic

Outcome Measures

Primary Outcomes (1)

• Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose

  From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra

Secondary Outcomes (3)

• Mean change of Total Symptom Score (sneezing, nasal discharge, nasal congestion, itchy nose, lacrimation, and eye itching

  Prior to exposure, and every 15 minutes for 5 hours after exposure start

• Overall patients' impression about efficacy of Dellegra after Dellegra internal use (Score 1 [none] to 7 [very severe])

  From intake of Dellegra up to 17 days

• Number of patients who experienced adverse events

  From intake of Dellegra up to 17 days

Study Arms (1)

Fexofenadine HCl

EXPERIMENTAL

2 tablets of Dellegra Combination Tablets (Fexofenadine Hydrochloride 30 mg+Pseudoephedrine Hydrochloride 60 mg/tablet), oral, administrated 2 hours after start of exposure with 8,000 grains/cubic meter of Japanese cedar pollen

Drug: Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg

Interventions

Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg DRUG

Pharmaceutical form:tablet Route of administration: oral

Fexofenadine HCl

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with seasonal allergic rhinitis.
• Patients with a history of symptoms of Japanese cedar pollinosis for at least 2 years.
• Positive radioallergosorbent test (RAST) for Japanese cedar pollen antigen (CAP-RAST class \>=2) within 1.5 years before the exposure test.
• Patients with Total Nasal Symptom Score of 8 or more, and nasal congestion scores of 2 (moderate) or more at least 1 assessment point of 90 to 150 minutes after the start of the screening exposure.
• Age ≥20 and ≤65 years.
• Patients written informed consent.

You may not qualify if:

• Patients with symptoms of perennial allergic rhinitis.
• Patients with severe asthma, bronchiectasis, severe hepatic, renal, or cardiac dysfunction, hematological, endocrine disease, and other serious complications.
• Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, deviation of the nasal septum, etc.) or eye diseases that could interfere with judgment of the efficacy of Dellegra Combination Tablets.
• Patients with evidence of upper and/or lower respiratory tract inflammation (acute rhinitis, chronic rhinitis, congestive rhinitis, atrophic rhinitis, purulent nasal discharge, sinusitis in the presence of cold-like, etc.) on the day of treatment exposure.
• Patients who have taken any of the following medications that may affect the evaluation of Dellegra Combination Tablets (except for the use of topical preparation in which investigator/sub-investigator judged them not to affect the efficacy evaluation; the treated site is different, etc.):
• Within 2 weeks prior to the day of the screening exposure test: Antiallergic drugs, antihistamines (H1 and H2 blockers: oral administration, nose drops, eye drops, injection, and topical use), anticholinergic agents, vasoconstrictor nose drops, 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, and eye itching etc.). Steroids (oral, inhaled, nose drops, eye drops, or topical use), immunosuppressants (oral, topical use, or injected), azole fungicides, and histamine containing gamma-globulin preparations.
• Within 4 weeks prior to the day of the screening exposure test: Depot steroid preparations.
• Patients who are considered by the investigator/sub-investigator to be unsuitable for enrollment in the study for any other criterion.
• Patients with a history of hypersensitivity to antihistamines or antihistaminic agent (fexofenadine HCI is included), and the pseudoephedrine hydrochloride.
• Patients with severe hypertension or severe coronary artery disease, narrow angle glaucoma, urinary retention, or those who have shown sensitivity to adrenergic agents (manifestations include insomnia, dizziness, weakness, tremor, or arrhythmias).
• Women who are pregnant, may be pregnant, or currently breast-feeding.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 392-001

Shinjuku-ku, Japan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

fexofenadine

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

JP (1)