A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis

April 29, 2010 updated by: Artu Biologicals

A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, B-8000
        • AZ St Jan, Campus Sint-Jan
      • Bruxelles, Belgium, B-1200
        • Clinique Saint Luc
      • Leuven, Belgium, B-3000
        • University Hospital Leuven
      • Leuven, Belgium, B-3000
        • U.Z. St Raphael
      • Liege, Belgium, B-4000
        • CHR de la Citadelle
      • Yvoir, Belgium, B-5530
        • Clinique UCL de Mont-Godinne
  • France
      • Bordeaux, France, 33000
        • Groupe Hospitalier Pellegrin
      • Brest, France, 29200
        • Gael Taburet
      • Nantes, France, 44000
        • Francois Durand Perdriel
      • Nantes, France, 44000
        • Francois Wessel
      • Nantes, France, 44000
        • Michel Anton
      • Quimper, France, 29000
        • Françoise Sanquer
      • Reze, France, 44400
        • Bruno Lebeaupin
      • Strasbourg cedex, France, 67091
        • CHRU de Strasbourg
      • Toulon, France, 83000
        • Mathieu Larrousse
  • Germany
      • Berlin, Germany, 10117
        • Allergie-Centrum-Charité
      • Bochum, Germany
        • Berufsgen. kliniken Bergmannsheil
      • Bonn, Germany, 53105
        • Universitätsklinik Bonn
      • Dresden, Germany, 01307
        • Uniklinikum Carl Gustav Carus
      • Frankfurt am Main, Germany, 60590
        • Uniklinikum Frankfurt
      • Goch, Germany
        • medicoKIT
      • Halle, Germany, 06112
        • Universitätsklinikum Halle (Saale)
      • Lübeck, Germany, 23538
        • Universitatsklinikum Schleswig-Holstein
      • München, Germany, 80337
        • Klinikum der Universität München
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
  • Netherlands
      • Alphen aan de Rijn, Netherlands, 2402 WC
        • Rijnland Ziekenhuis, Location Alphen - Poli KNO
      • Assen, Netherlands
        • Wilhelmina ziekenhuis
      • De Bilt, Netherlands, 3731 DN
        • Ampha De Bilt
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Nijmegen, Netherlands, 6525EC
        • AMPHA Nijmegen
      • Tilburg, Netherlands, 5022 GC
        • Sint Elisabeth Ziekenhuis
  • Poland
      • Bialystok, Poland, 15-084
        • Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny
      • Bienkowka, Poland, 34-212
        • SP-ZOZ Osrodek Zdrowia w Bienkowce
      • Bydgoszcz, Poland, 85-168
        • SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela
      • Katowice, Poland, 40-084
        • Slaskie Centrum Osteoporozy
      • Lodz, Poland, 90-153
        • SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1
      • Lodz, Poland, 90-553
        • NZOZ Centrum Alergologii Prof. Buczylko
      • Lublin, Poland, 20-718
        • SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
      • Poznan, Poland, 60-214
        • Centrum Alergologii Teresa Hofman
      • Wroclaw, Poland, 54-239
        • NZOZ Lekarze Specjalisci
      • Zabrze, Poland, 41-800
        • Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
      • Zabrze, Poland, 41-803
        • Samodzielny Publiczny Szpital Kliniczny nr 3
  • United Kingdom
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
        • Layton Medical Centre
      • Brighton, United Kingdom, BN2 3 EW
        • Brighton General Hospital
      • Chippenham, United Kingdom, SN14 6GT
        • Hathaway Medical Centre
      • Crownhill, Plymouth, United Kingdom, PL5 3JB
        • House Surgery
      • London, United Kingdom, W2 1NY
        • St. Mary's Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, WC1X 8DA
        • Royal National Throat, Nose & Ear Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • QMC Notthingham, Nottingham University Hospitals NHS Trust
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • St Stephen, St Austell, United Kingdom, PL26 7RL
        • Brannel Surgery
      • Warminster, United Kingdom, BA12 9AA
        • Avenue Surgery
    • Cornwal
      • Fowey, Cornwal, United Kingdom, Pl23 1DT
        • Fowey River Practice
    • Cornwall
      • Penzance, Cornwall, United Kingdom, TR18 4JH
        • The Alverton Practice
      • Saltash, Cornwall, United Kingdom, PL12 6DL
        • Saltash Health Centre
      • St Just, Cornwall, United Kingdom, TR19 7HX
        • Cape Cornwall Surgery
    • Past Sussex
      • Bexhill-on-Sea, Past Sussex, United Kingdom, TN40 1JJ
        • Sea Road Surgery
    • Warwickshire
      • Atherstone, Warwickshire, United Kingdom, CV9 1EU
        • Atherstone Surgery
    • Wiltshire
      • Corsham, Wiltshire, United Kingdom, SN13 9DL
        • The Porch Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female
  • grass pollen related rhinoconjunctivitis symptoms for at least the last 2 pollen seasons
  • positive skin prick test RRTSS greater or equal to 12 during the 2008 season
  • signed informed consent

Exclusion Criteria:

  • positive skin prick test for other environmental allergens and suffering from serious allergic symptoms
  • clinical history of significant symptomatic allergic rhinitis due to tree/weed pollen which potentially overlap the grass pollen season
  • clinical history of symptomatic perennial allergic rhinitis caused by an allergen to which the patient is regularly exposed
  • lacking of good health
  • abnormal spirometry
  • lower respiratory tract infection
  • asthma requiring treatment other than beta-2 agonists
  • oral steroids within 12 weeks before screening
  • regular contraindications for use of immunotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Grass pollen extract
Subjects will receive 19.000 BU grass pollen extract daily sublingually
Drug: Oralgen
19.000 BU daily
Other Names:
  • Grass pollen extract
Placebo Comparator: Placebo control
Subjects will receive matching placebo control daily sublingually
Other: placebo control
placebo control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Difference between active and placebo-group based on combined RTSS and RMS score
Time Frame: third season
third season

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Difference between active and placebo based on RTSS score
Time Frame: third season
third season

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Artu Biologicals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Folkert Roossien, Artu-Biologicals Europe B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AB0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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