AzTrials
AzTrials

Perennial Allergic RhinitisPhase 3NCT01127620

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

A Phase 3 study testing Bilastine and Cetirizine in people with Perennial Allergic Rhinitis, run by Faes Farma, S.A..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 70 years
Conditions the study is for
Perennial Allergic Rhinitis
What is being tested?
Bilastine and Cetirizine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
No sites listed yet
Study dates
May 2004to Nov 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

About this study

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

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

Read the 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%)

Being tested
Bilastine, Cetirizine, Placebo
Keywords
Allergic Rhinoconjunctivitis, Persistent allergic rhinitis, Hay fever, Allergic Rhinitis, Sneezing, Nasal congestion, Rhinorrhea, Nasal itching, Ocular itching, Ocular tearing, Antihistamine
Medical subject headings
Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Sneezing, Nasal Obstruction, Rhinorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BilastineDrug

    20 mg encapsulated tablets

  • CetirizineDrug

    Also called Zyrtec

    10 mg encapsulated tablets

  • PlaceboDrug

    encapsulated tablets

Study groups in NCT01127620
Study groupRoleWhat they receive
BilastineExperimental20 mg encapsulated tablets
Receives: Drug: Bilastine
CetirizineActive comparator10 mg encapsulated tablets
Receives: Drug: Cetirizine
PlaceboPlacebo comparatorEncapsulated tablets
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

  2. 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.

    Measured: 12 months

Secondary outcomes (13)

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

    Measured: 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)

    Measured: Day 14 and day 28

  3. 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)

    Measured: Day 14 and day 28

  4. 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)

    Measured: Day 14 and day 28

  5. 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)

    Measured: Day 14 and day 28

  6. 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

    Measured: 28 days

  7. 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

    Measured: 28 days

  8. Overall assessment of discomfort

    Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D14 and D28 visits

    Measured: Day 14 and day 28

  9. Investigator's clinical global impression

    Measured: 28 days

  10. Quality of Life change from baseline

    Measured: 28 days

  11. 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.

    Measured: 28 days

  12. Time to maximum response

    Time to maximum response was described using Kaplan-Meier estimates and was compared (Log-rank test) between treatment groups.

    Measured: 48 hours

  13. 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.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2010 (estimated)
  2. Study startMay 2004
  3. Primary completionMar 2006
  4. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127620
Sponsor's protocol ID
BILA 1503/RAP
Status last verified
Sep 2012
First submitted
19 May 2010
Last updated
26 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22149770

  • 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.

    PubMed 22077106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bilastine and Cetirizine in people with Perennial Allergic Rhinitis, run by Faes Farma, S.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double-blind phase: AUC of TSS throughout the study (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01127620, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in