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

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ClinicalTrials.gov Identifier: NCT01127620
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.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


Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Drug: Bilastine Drug: Cetirizine Drug: Placebo Phase 3

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%)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bilastine
20 mg encapsulated tablets
Drug: Bilastine
20 mg encapsulated tablets

Active Comparator: Cetirizine
10 mg encapsulated tablets
Drug: Cetirizine
10 mg encapsulated tablets
Other Name: Zyrtec

Placebo Comparator: Placebo
Encapsulated tablets
Drug: Placebo
encapsulated tablets




Primary Outcome Measures :
  1. Double-blind phase: AUC of TSS throughout the study [ Time Frame: 28 days ]
    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.

  2. Open-label phase: Long-term safety [ Time Frame: 12 months ]
    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 :
  1. AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms. [ Time Frame: 28 days ]
  2. 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 ]
  3. Change in Nasal Symptoms Score (NSS) [ Time Frame: Day 14 and day 28 ]
    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)

  4. Change in Non Nasal Symptoms Score (NNSS) [ Time Frame: Day 14 and day 28 ]
    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)

  5. Change in individual nasal and non nasal symptoms [ Time Frame: Day 14 and day 28 ]
    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)

  6. AUC of NSS, NNSS and each individual nasal andn non nasal symptom [ Time Frame: 28 days ]
    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

  7. AUC of NSS, NNSS and each individual symptom according to patient's instantaneous assessment [ Time Frame: 28 days ]
    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

  8. Overall assessment of discomfort [ Time Frame: Day 14 and day 28 ]
    Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D14 and D28 visits

  9. Investigator's clinical global impression [ Time Frame: 28 days ]
  10. Quality of Life change from baseline [ Time Frame: 28 days ]
  11. Responders rate [ Time Frame: 28 days ]
    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.

  12. Time to maximum response [ Time Frame: 48 hours ]
    Time to maximum response was described using Kaplan-Meier estimates and was compared (Log-rank test) between treatment groups.

  13. Safety and tolerability [ Time Frame: 28 days ]
    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.



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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01127620


Sponsors and Collaborators
Faes Farma, S.A.
Investigators
Principal Investigator: Piotr Kuna, Prof. MD. Barlicki University Hospital, Medical University of Lodz (Poland)

Publications of Results:
Other Publications:
Responsible Party: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT01127620     History of Changes
Other Study ID Numbers: BILA 1503/RAP
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by Faes Farma, S.A.:
Allergic Rhinoconjunctivitis
Persistent allergic rhinitis
Hay fever
Allergic Rhinitis
Sneezing
Nasal congestion
Rhinorrhea
Nasal itching
Ocular itching
Ocular tearing
Antihistamine

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
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