Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis
This study has been completed.
Sponsor:
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00504933
First Posted: July 20, 2007
Last Update Posted: April 5, 2012
Information provided by (Responsible Party):
Faes Farma, S.A.
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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
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| 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
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): 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 ) |
| First Submitted: | July 19, 2007 |
| First Posted: | July 20, 2007 |
| Last Update Posted: | April 5, 2012 |
| Last Verified: | April 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 |