Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension

NCT01127620 | Completed Phase 3

• 1 other identifier: BILA 1503/RAP
• Study Type: interventional
• Target: 650
• Locations: 0 countries
• Sites: N/A

Brief Summary

Double-blind phase: The objective of the study was to evaluate the efficacy and safety of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic rhinitis. Open-label Phase: The objective of this extension was to evaluate the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis

Conditions

Perennial Allergic Rhinitis

Keywords

Allergic Rhinoconjunctivitis; Persistent allergic rhinitis; Hay fever; Allergic Rhinitis; Sneezing; Nasal congestion; Rhinorrhea; Nasal itching; Ocular itching; Ocular tearing; Antihistamine

Outcome Measures

Primary Outcomes (2)

• Double-blind phase: AUC of TSS throughout the study

  Area under curve (AUC) of total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the patients' diary before randomization) to D28 visit according to the patient's assessment on reflective symptoms.

  28 days

• Open-label phase: Long-term safety

  Evaluation of the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis. The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study), ECGs on M3, M6, M9 and M12 visits and routine laboratory analyses (haematology and biochemistry) performed at M3, M6, M9 and M12 visits.

  12 months

Secondary Outcomes (13)

• AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms.

  28 days

• Change in the TSS on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)

  Day 14 and day 28

• Change in Nasal Symptoms Score (NSS)

  Day 14 and day 28

• Change in Non Nasal Symptoms Score (NNSS)

  Day 14 and day 28

• Change in individual nasal and non nasal symptoms

  Day 14 and day 28

Study Arms (3)

Bilastine

EXPERIMENTAL

20 mg encapsulated tablets

Drug: Bilastine

Cetirizine

ACTIVE COMPARATOR

10 mg encapsulated tablets

Drug: Cetirizine

Placebo

PLACEBO COMPARATOR

Encapsulated tablets

Drug: Placebo

Interventions

Bilastine DRUG

20 mg encapsulated tablets

Bilastine

Cetirizine DRUG

10 mg encapsulated tablets

Also known as: Zyrtec

Cetirizine

Placebo DRUG

encapsulated tablets

Placebo

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex aged from 12 to 70 years of age
• Positive skin prick test for at least one of the following perennial allergens (house-dust mites, Dermatophagoides pteronyssinus or D. farinae, animal danders, dogs or cats, molds, etc.)
• Patients had to have a sum in the previous 6 assessments of the reflective nasal symptoms score equal to or greater than 30 (≥30 over 72). Additionally, at the time of randomization patients had to have positive symptomatology in instantaneous nasal symptoms equal or greater than 5 (≥5 over 12).
• Women of childbearing potential had to have a negative pregnancy test and had to use an effective contraceptive method.
• Provision of written informed consent to participate and willing to attend the required visits scheduled in the protocol
• The criteria to continue with the open label period included previous participation in the double blind period, eligibility for a long-term symptomatic treatment according to the investigator assessment and patient willingness to follow the treatment for one year.

You may not qualify if:

• 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.
• Immunotherapy (6 months): In case of patients under immunotherapy the treatment had to have started more than 6 months prior to the start of the study, the doses could not be modified during the study, and any doses could not be administered 24 hours before any study visit..
• Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period
• Severe concomitant disease that could interfere with treatment response (hepatic, renal, cardiovascular), electrocardiographic abnormalities, arrhythmia, recent acute myocardial infarction or neoplastic diseases

Sponsors & Collaborators

• Faes Farma, S.A.: lead

Related Publications (2)

• Bousquet J, Ansotegui I, Canonica GW, Zuberbier T, Baena-Cagnani CE, Bachert C, Cruz AA, Gonzalez SN, Kuna P, Morais-Almeida M, Mullol J, Ryan DP, Sanchez-Borges M, Valiente R, Church MK. Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: evidence review. Curr Med Res Opin. 2012 Jan;28(1):131-9. doi: 10.1185/03007995.2011.648263. Epub 2011 Dec 22.

  PMID: 22149770 BACKGROUND

• Sastre J, Mullol J, Valero A, Valiente R; Bilastine Study Group. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo in the treatment of perennial allergic rhinitis. Curr Med Res Opin. 2012 Jan;28(1):121-30. doi: 10.1185/03007995.2011.640667. Epub 2011 Nov 30.

  PMID: 22077106 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic; Sneezing; Nasal Obstruction; Rhinorrhea

Interventions

bilastine; Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Piotr Kuna, Prof. MD.

  Barlicki University Hospital, Medical University of Lodz (Poland)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 21, 2010
• Study Start: May 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: November 1, 2006
• Last Updated: September 26, 2012

Record last verified: 2012-09