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Trial record 1 of 1 for:    fexhyl06934
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Evaluation of Efficacy of Dellegra in Exposure Unit

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ClinicalTrials.gov Identifier: NCT02175485
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Rhinitis Allergic Drug: Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg Phase 4

Detailed Description:
It will be 8 days at minimum and up to 17 days depending on screening visit and post-treatment observation allowances.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen Exposure in Japanese Population. Open Label Study
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fexofenadine HCl
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
Pharmaceutical form:tablet Route of administration: oral




Primary Outcome Measures :
  1. Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose [ Time Frame: From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra ]

Secondary Outcome Measures :
  1. Mean change of Total Symptom Score (sneezing, nasal discharge, nasal congestion, itchy nose, lacrimation, and eye itching [ Time Frame: Prior to exposure, and every 15 minutes for 5 hours after exposure start ]
  2. Overall patients' impression about efficacy of Dellegra after Dellegra internal use (Score 1 [none] to 7 [very severe]) [ Time Frame: From intake of Dellegra up to 17 days ]
  3. Number of patients who experienced adverse events [ Time Frame: From intake of Dellegra up to 17 days ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175485


Locations
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Japan
Investigational Site Number 392-001
Shinjuku-ku, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02175485     History of Changes
Other Study ID Numbers: FEXHYL06934
U1111-1152-0373 ( Other Identifier: UTN )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pseudoephedrine
Ephedrine
Fexofenadine
Terfenadine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists