Back to resultsEfficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bilastine
Cetirizine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Allergic Rhinoconjunctivitis, Persistent allergic rhinitis, Hay fever, Allergic Rhinitis, Sneezing, Nasal congestion, Rhinorrhea, Nasal itching, Ocular itching, Ocular tearing, Antihistamine
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Bilastine
Cetirizine
Placebo
Arm Description
20 mg encapsulated tablets
10 mg encapsulated tablets
Encapsulated tablets
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms.
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)
Change in Nasal Symptoms Score (NSS)
Change in Nasal Symptoms Score (NSS) on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Change in Non Nasal Symptoms Score (NNSS)
Change in Non Nasal Symptoms Score (NNSS) on symptom scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Change in individual nasal and non nasal symptoms
Change in each of the NSS or NNSS on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)
AUC of NSS, NNSS and each individual nasal andn non nasal symptom
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on reflective symptoms
AUC of NSS, NNSS and each individual symptom according to patient's instantaneous assessment
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on instantaneous symptoms. Time to maximum relief of symptoms
Overall assessment of discomfort
Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D14 and D28 visits
Investigator's clinical global impression
Quality of Life change from baseline
Responders rate
Responders were classified based on their total symptom score decrease to baseline: <25%, 25%-50%, 50%-75%, >75% and were described by treatment group with their percentage and 95% confidence interval.
Time to maximum response
Time to maximum response was described using Kaplan-Meier estimates and was compared (Log-rank test) between treatment groups.
Safety and tolerability
The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study, ECGs on D0 and D28 visits and routine laboratory analyses (haematology and biochemistry) performed at D0 and D28 visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01127620
Brief Title
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faes Farma, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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%)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
Allergic Rhinoconjunctivitis, Persistent allergic rhinitis, Hay fever, Allergic Rhinitis, Sneezing, Nasal congestion, Rhinorrhea, Nasal itching, Ocular itching, Ocular tearing, Antihistamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
650 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilastine
Arm Type
Experimental
Arm Description
20 mg encapsulated tablets
Arm Title
Cetirizine
Arm Type
Active Comparator
Arm Description
10 mg encapsulated tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Encapsulated tablets
Intervention Type
Drug
Intervention Name(s)
Bilastine
Intervention Description
20 mg encapsulated tablets
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Other Intervention Name(s)
Zyrtec
Intervention Description
10 mg encapsulated tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
encapsulated tablets
Primary Outcome Measure Information:
Title
Double-blind phase: AUC of TSS throughout the study
Description
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.
Time Frame
28 days
Title
Open-label phase: Long-term safety
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms.
Time Frame
28 days
Title
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)
Time Frame
Day 14 and day 28
Title
Change in Nasal Symptoms Score (NSS)
Description
Change in Nasal Symptoms Score (NSS) on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Time Frame
Day 14 and day 28
Title
Change in Non Nasal Symptoms Score (NNSS)
Description
Change in Non Nasal Symptoms Score (NNSS) on symptom scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Time Frame
Day 14 and day 28
Title
Change in individual nasal and non nasal symptoms
Description
Change in each of the NSS or NNSS on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)
Time Frame
Day 14 and day 28
Title
AUC of NSS, NNSS and each individual nasal andn non nasal symptom
Description
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on reflective symptoms
Time Frame
28 days
Title
AUC of NSS, NNSS and each individual symptom according to patient's instantaneous assessment
Description
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on instantaneous symptoms. Time to maximum relief of symptoms
Time Frame
28 days
Title
Overall assessment of discomfort
Description
Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D14 and D28 visits
Time Frame
Day 14 and day 28
Title
Investigator's clinical global impression
Time Frame
28 days
Title
Quality of Life change from baseline
Time Frame
28 days
Title
Responders rate
Description
Responders were classified based on their total symptom score decrease to baseline: <25%, 25%-50%, 50%-75%, >75% and were described by treatment group with their percentage and 95% confidence interval.
Time Frame
28 days
Title
Time to maximum response
Description
Time to maximum response was described using Kaplan-Meier estimates and was compared (Log-rank test) between treatment groups.
Time Frame
48 hours
Title
Safety and tolerability
Description
The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study, ECGs on D0 and D28 visits and routine laboratory analyses (haematology and biochemistry) performed at D0 and D28 visits.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Kuna, Prof. MD.
Organizational Affiliation
Barlicki University Hospital, Medical University of Lodz (Poland)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22149770
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.
Results Reference
background
PubMed Identifier
22077106
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.
Results Reference
result
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Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
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