Clinical trial NCT01127620: Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
Official title: A Phase III, Comparative Study for the Efficacy and Safety of Bilastine 20 mg Versus Cetirizine 10 mg and Placebo in the Treatment of Perennial Allergic Rhinitis During 4 Weeks, Followed by a Long-term Safety Extension With Bilastine 20 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 650
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Double-blind, randomized, placebo-controlled, parallel-group, international, multicenter study followed by an open label extension. Duration of the double-blind period was 28 days and the duration of the open label period was 12 additional months.

The primary efficacy variable of the double-blind period was the 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. 650 patients were included in the study and 614 completed the double-blind phase. Out of the 614 patients who completed the double blind period, a total of 513 patients started the open label period with Bilastine 20 mg (83.6%)

Eligibility criteria: Inclusion Criteria:

* Patients of either sex aged from 12 to 70 years of age
* Patients with a documented clinical history of PAR for at least 2 years prior to the study inclusion
* 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.

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 are also diagnosed with SAR (seasonal allergic rhinitis), and the inclusion and follow-up during the double-blind phase in this study is concurrent with the pollen season.
* 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

Primary outcomes:
measure: Double-blind phase: AUC of TSS throughout the study
timeFrame: 28 days
measure: Open-label phase: Long-term safety
timeFrame: 12 months
Secondary outcomes:
measure: AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms.
timeFrame: 28 days
measure: 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)
timeFrame: Day 14 and day 28
measure: Change in Nasal Symptoms Score (NSS)
timeFrame: Day 14 and day 28
measure: Change in Non Nasal Symptoms Score (NNSS)
timeFrame: Day 14 and day 28
measure: Change in individual nasal and non nasal symptoms
timeFrame: Day 14 and day 28
measure: AUC of NSS, NNSS and each individual nasal andn non nasal symptom
timeFrame: 28 days
measure: AUC of NSS, NNSS and each individual symptom according to patient's instantaneous assessment
timeFrame: 28 days
measure: Overall assessment of discomfort
timeFrame: Day 14 and day 28
measure: Investigator's clinical global impression
timeFrame: 28 days
measure: Quality of Life change from baseline
timeFrame: 28 days
measure: Responders rate
timeFrame: 28 days
measure: Time to maximum response
timeFrame: 48 hours
measure: Safety and tolerability
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Barlicki University Hospital, Medical University of Lodz (Poland)
name: Piotr Kuna, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.