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Allergic RhinoconjunctivitisPhase 3NCT00812799

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

A Phase 3 study testing Oralgen in people with Allergic Rhinoconjunctivitis, run by Artu Biologicals at 60 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Allergic Rhinoconjunctivitis
What is being tested?
Oralgen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
60 sitesin 6 countries
Study dates
Dec 2008to Dec 2011
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • asthma requiring treatment other than beta-2 agonists
  • oral steroids within 12 weeks before screening
  • regular contraindications for use of immunotherapy

Trial locations and contacts

60 sites in 6 countries.

60 sites in 6 countries

United Kingdom18 sites

  • Atherstone Surgery

    Atherstone, Warwickshire, CV9 1EU

  • Sea Road Surgery

    Bexhill-on-Sea, Past Sussex, TN40 1JJ

  • Layton Medical Centre

    Blackpool, Lancashire, FY3 7EN

  • Brighton General Hospital

    Brighton, BN2 3 EW

  • Hathaway Medical Centre

    Chippenham, SN14 6GT

  • The Porch Surgery

    Corsham, Wiltshire, SN13 9DL

  • House Surgery

    Crownhill, Plymouth, PL5 3JB

  • Fowey River Practice

    Fowey, Cornwal, Pl23 1DT

  • Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • St. Mary's Hospital

    London, W2 1NY

  • Royal National Throat, Nose & Ear Hospital

    London, WC1X 8DA

  • QMC Notthingham, Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • The Alverton Practice

    Penzance, Cornwall, TR18 4JH

  • Brannel Surgery

    Saint Stephen, Saint Austell, PL26 7RL

  • Saltash Health Centre

    Saltash, Cornwall, PL12 6DL

  • Northern General Hospital

    Sheffield, S5 7AU

  • Cape Cornwall Surgery

    St Just, Cornwall, TR19 7HX

  • Avenue Surgery

    Warminster, BA12 9AA

Other trials in United Kingdom

Poland11 sites

  • Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny

    Bialystok, 15-084

  • SP-ZOZ Osrodek Zdrowia w Bienkowce

    Bieńkówka, 34-212

  • SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela

    Bydgoszcz, 85-168

  • Slaskie Centrum Osteoporozy

    Katowice, 40-084

  • SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1

    Lodz, 90-153

  • NZOZ Centrum Alergologii Prof. Buczylko

    Lodz, 90-553

  • SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

    Lublin, 20-718

  • Centrum Alergologii Teresa Hofman

    Poznan, 60-214

  • NZOZ Lekarze Specjalisci

    Wroclaw, 54-239

  • Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

    Zabrze, 41-800

  • Samodzielny Publiczny Szpital Kliniczny nr 3

    Zabrze, 41-803

Other trials in Poland

Germany10 sites

  • Allergie-Centrum-Charité

    Berlin, 10117

  • Berufsgen. kliniken Bergmannsheil

    Bochum

  • Universitätsklinik Bonn

    Bonn, 53105

  • Uniklinikum Carl Gustav Carus

    Dresden, 01307

  • Uniklinikum Frankfurt

    Frankfurt am Main, 60590

  • MedicoKIT

    Goch

  • Universitätsklinikum Halle (Saale)

    Halle, 06112

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum der Universität München

    München, 80337

  • Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

France9 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33000

  • Gael Taburet

    Brest, 29200

  • Francois Durand Perdriel

    Nantes, 44000

  • Francois Wessel

    Nantes, 44000

  • Michel Anton

    Nantes, 44000

  • Françoise Sanquer

    Quimper, 29000

  • Bruno Lebeaupin

    Rezé, 44400

  • CHRU de Strasbourg

    Strasbourg, 67091

  • Mathieu Larrousse

    Toulon, 83000

Other trials in France

Belgium6 sites

  • AZ St Jan, Campus Sint-Jan

    Bruges, B-8000

  • Clinique Saint Luc

    Brussels, B-1200

  • U.Z. St Raphael

    Leuven, B-3000

  • University Hospital Leuven

    Leuven, B-3000

  • CHR de la Citadelle

    Liège, B-4000

  • Clinique UCL de Mont-Godinne

    Yvoir, B-5530

Other trials in Belgium

Netherlands6 sites

  • Rijnland Ziekenhuis, Location Alphen - Poli KNO

    Alphen aan den Rijn, 2402 WC

  • Wilhelmina ziekenhuis

    Assen

  • Ampha De Bilt

    De Bilt, 3731 DN

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • AMPHA Nijmegen

    Nijmegen, 6525EC

  • Sint Elisabeth Ziekenhuis

    Tilburg, 5022 GC

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Oralgen, placebo control
Keywords
randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, allergy, rhinoconjunctivitis, immunotherapy, grass pollen extract
Medical subject headings
Hypersensitivity

What participants receive

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

  • OralgenDrug

    Also called Grass pollen extract

    19.000 BU daily

  • placebo controlOther

    placebo control

Study groups in NCT00812799
Study groupRoleWhat they receive
Grass pollen extractActive comparatorSubjects will receive 19.000 BU grass pollen extract daily sublingually
Receives: Drug: Oralgen
Placebo controlPlacebo comparatorSubjects will receive matching placebo control daily sublingually
Receives: Other: placebo control

What is being measured

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

  1. Difference between active and placebo-group based on combined RTSS and RMS score

    Measured: third season

Secondary outcomes (1)

  1. Difference between active and placebo based on RTSS score

    Measured: third season

Timeline

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

  1. First posted22 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionAug 2011 (estimated)
  4. Study completionDec 2011 (estimated)

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00812799
Sponsor's protocol ID
AB0801
Status last verified
Apr 2010
First submitted
19 Dec 2008
Last updated
30 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oralgen in people with Allergic Rhinoconjunctivitis, run by Artu Biologicals at 60 sites in 6 countries.

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 4 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: status not confirmed, as of the sponsor's last update on 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United Kingdom, Poland, Germany, France, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

Difference between active and placebo-group based on combined RTSS and RMS score (time frame: third season). 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 NCT00812799.

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 30 Apr 2010.

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