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

Primary Purpose

Rhinitis Allergic

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FEX60/PE10
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis Allergic

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Outpatients with a history of seasonal or perennial allergic rhinitis for at least 1 year confirmed by positive skin prick test to out or indoor allergens (wheal ≥3mm compared to control [diluent]) or positive specific IgE Antibody test (ie, radioallergosorbent test [RAST], etc.) on the day of provisional inclusion in the trial.
  • Patients who meet the following criteria of symptom score. (The symptom score is rated according to the 'Severity of nasal symptoms'):

    1. Nasal congestion score is consistently from 2 to 3 but not 4 for the last 3 days of the screening period.
    2. 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.

Exclusion criteria:

  • 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.
  • Patients who have taken any of the following medications that may affect the evaluation of the IP, Patients using intranasal or systemic decongestants if they are not stopped 3 days before the inclusion visit.

    1. 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).
    2. Within 2 weeks prior to the day of registration:

      o Steroids, immunosuppressant, and nonspecific alternative therapy (histamine-containing gamma-globulin preparations etc).

    3. Within 4 weeks prior to the day of registration:

      • Patients receiving oral, nasal, inhaled corticosteroids.
      • Depot steroid preparations.
  • Patients using sodium cromoglycate/nedocromil or leukotriene modifiers if they are not stopped 14 days before the inclusion.
  • 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 suffering from Upper Respiratory Tract Infection, sinusitis or acute otitis media within 30 days before the inclusion visit.
  • 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.
  • Patients who are considered by the Investigator/sub-investigator to be unsuitable for enrolment in the study for any other criterion or previously participated in this study.
  • Patients with a history of hypersensitivity to antihistamines or antiallergic agents including FEX.
  • 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).
  • Patients receiving monoamine oxidase (MAO) inhibitor therapy or within 2 weeks prior to the day of registration.
  • Women who are pregnant, possibly pregnant, or breast-feeding.
  • Patients with underlying hepatobiliary disease. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sanofi Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FEX60/PE10

Arm Description

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

Outcomes

Primary Outcome Measures

Number of adverse events (Solicited AE reporting)
Changes from baseline in the nasal congestion score based on the patient's symptom diary

Secondary Outcome Measures

Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
Change in the total score of 3 nasal symptoms on a daily basis
Change in the total score of 3 nasal symptoms during daytime
Change in the total score of 3 nasal symptoms during night-time
Change in the daily activity impairment score
Change in the daily activity impairment score on a daily basis
Change in the daily activity impairment score during daytime
Change in the daily activity impairment score during night-time
Change in nasal findings from baseline: color of inferior turbinate mucosa
Change in nasal findings from baseline: congestion of inferior turbinate mucosa
Change in nasal findings from baseline: consistency of discharge
Assessment of patient's impression after treatment based on patient's symptom diary

Full Information

First Posted
March 24, 2015
Last Updated
November 26, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02401191
Brief Title
A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis
Official Title
A Non-controlled, Open Study for Assessing the Safety and Effectiveness of a Twice-daily FEX 60 mg - PE 10 mg (FEX60/PE10) Fixed Combination Tablet in Patients With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
It will be 22 days at minimum and up to 32 days depending on screening, treatment, and post-treatment observation allowances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis Allergic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FEX60/PE10
Arm Type
Experimental
Arm Description
Internal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks
Intervention Type
Drug
Intervention Name(s)
FEX60/PE10
Intervention Description
Pharmaceutical form:tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Number of adverse events (Solicited AE reporting)
Time Frame
From intake of FEX60/PE10 up to approximately 2 weeks
Title
Changes from baseline in the nasal congestion score based on the patient's symptom diary
Time Frame
After 2 weeks treatment
Secondary Outcome Measure Information:
Title
Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
Time Frame
After 2 weeks treatment
Title
Change in the total score of 3 nasal symptoms on a daily basis
Time Frame
After 2 weeks treatment
Title
Change in the total score of 3 nasal symptoms during daytime
Time Frame
After 2 weeks treatment
Title
Change in the total score of 3 nasal symptoms during night-time
Time Frame
After 2 weeks treatment
Title
Change in the daily activity impairment score
Time Frame
After 2 weeks treatment
Title
Change in the daily activity impairment score on a daily basis
Time Frame
After 2 weeks treatment
Title
Change in the daily activity impairment score during daytime
Time Frame
After 2 weeks treatment
Title
Change in the daily activity impairment score during night-time
Time Frame
After 2 weeks treatment
Title
Change in nasal findings from baseline: color of inferior turbinate mucosa
Time Frame
After 2 weeks treatment
Title
Change in nasal findings from baseline: congestion of inferior turbinate mucosa
Time Frame
After 2 weeks treatment
Title
Change in nasal findings from baseline: consistency of discharge
Time Frame
After 2 weeks treatment
Title
Assessment of patient's impression after treatment based on patient's symptom diary
Time Frame
After 2 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Outpatients with a history of seasonal or perennial allergic rhinitis for at least 1 year confirmed by positive skin prick test to out or indoor allergens (wheal ≥3mm compared to control [diluent]) or positive specific IgE Antibody test (ie, radioallergosorbent test [RAST], etc.) on the day of provisional inclusion in the trial. 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. Exclusion criteria: 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. Patients who have taken any of the following medications that may affect the evaluation of the IP, Patients using intranasal or systemic decongestants if they are not stopped 3 days before the inclusion visit. 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 using sodium cromoglycate/nedocromil or leukotriene modifiers if they are not stopped 14 days before the inclusion. 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 suffering from Upper Respiratory Tract Infection, sinusitis or acute otitis media within 30 days before the inclusion visit. 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. Patients who are considered by the Investigator/sub-investigator to be unsuitable for enrolment in the study for any other criterion or previously participated in this study. Patients with a history of hypersensitivity to antihistamines or antiallergic agents including FEX. 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). Patients receiving monoamine oxidase (MAO) inhibitor therapy or within 2 weeks prior to the day of registration. Women who are pregnant, possibly pregnant, or breast-feeding. Patients with underlying hepatobiliary disease. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi Administrative Office
City
Tokyo
Country
Japan

12. IPD Sharing Statement

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

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