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Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis
This study has been completed.
Sponsor:
Faes Farma, S.A.
Information provided by (Responsible Party):
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00504933
First received: July 19, 2007
Last updated: April 4, 2012
Last verified: April 2012
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Purpose
The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.
| Condition | Intervention | Phase |
|---|---|---|
| Seasonal Allergic Rhinitis | Drug: bilastine Drug: Cetirizine Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Cetirizine 10 mg for the Treatment of Seasonal Allergic Rhinitis. |
Resource links provided by NLM:
Further study details as provided by Faes Farma, S.A.:
Primary Outcome Measures:
- Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms. [ Time Frame: 14 days ]
Secondary Outcome Measures:
- AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms. [ Time Frame: 14 days ]
- Change from baseline at day 7 and day 14 for the following: Patient-rated (reflective and instantaneous) and Investigator-rated (instantaneous; assessed during study visit) TSS, NSS, NNSS and change for each individual symptom. [ Time Frame: 14 days ]
- Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.
- Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14
- Responders Rate: responders will be classified based on their TSS decrease from baseline: no responders (<25%), >25%<50%, >50%<75%, >75% and will be described by treatment group with their percentage
| Enrollment: | 683 |
| Study Start Date: | May 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Bilastine
|
Drug: bilastine
20 mg (encapsulated) tablets QD/14days
|
|
Active Comparator: B
Cetirizine
|
Drug: Cetirizine
10 mg (encapsulated) tablets. QD/14 days
Other Name: Zyrtec
|
|
Placebo Comparator: C
Placebo
|
Drug: Placebo
(encapsulated) Tablets QD/14 days
|
Detailed Description:
In this pivotal, multicentre, international, randomized, double-blind, placebo and active-comparator controlled, parallel study, 683 patients with SAR will be enrolled. Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test, total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.
Eligibility| Ages Eligible for Study: | 12 Years to 70 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients of either sex between 12 and 70 years of age.
- Patients with documented clinical history of SAR, for at least 2 years prior to the study inclusion.
- Positive skin prick test for at least one of the seasonal allergen specific of the geographical area.
- A previous positive Prick test, or a positive IgE Test (RAST) may also be accepted for inclusion, if performed within 12 months prior to the inclusion.
Exclusion Criteria:
- Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.).
- Negative skin prick test (as defined in point 6.1.1.).
- Patients with nasal polyps or a significant deviation of the nasal septum as judged by the investigator as well as nasal intervention in the previous 6 months. Any other nasal illness that can interfere with the aim of the study.
- Patients who have acute or chronic sinusitis as judged by the investigator.
- Patients who have received anti-allergy immunotherapy in the previous two years or are still receiving this kind of therapy.
- Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00504933
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504933
Sponsors and Collaborators
Faes Farma, S.A.
Investigators
| Principal Investigator: | Piotr Kuna, Prof. Dr | Barlicki University Hospital, Medical University of Lodz (Poland) |
More Information
Publications:
| Responsible Party: | Faes Farma, S.A. |
| ClinicalTrials.gov Identifier: | NCT00504933 History of Changes |
| Other Study ID Numbers: |
BILA 1704/RAE 2004-004586-14 ( EudraCT Number ) |
| Study First Received: | July 19, 2007 |
| Last Updated: | April 4, 2012 |
Keywords provided by Faes Farma, S.A.:
|
Rhinitis Allergic Seasonal Hay Fever |
Pollen Allergy Pollinosis Rhinoconjunctivitis |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Cetirizine Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 17, 2017