Allergic RhinoconjunctivitisPhase 3GT-19NCT01740284
A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine
A Phase 3 study testing Grazax + Aerius in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in Germany.
Trial summary
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Grazax + Aerius
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Jan 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18-65 years of age
- Written informed consent obtained before any clinical trial procedures are performed
- A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- Reporting of treatment related allergic AEs (local reactions in mouth and throat) after intake of Grazax at screening (visit 1)
- Positive skin prick test (SPT) response (wheal diameter ≥ 3 mm larger than the negative control with a flare) to Phleum pratense
- Female subjects had to be non-pregnant and non-lactating.
- Subject willing and able to comply with the protocol
Who cannot join
- Uncontrolled asthma in the past 12 months
- FEV1 < 70% of predicted value (calculated according to ECCS (20))
- A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen which might have caused symptoms during the conduct of this trial
- A clinical history of significant symptomatic perennial rhinitis or allergic rhinitis/asthma caused by an allergen to which the subject was regularly exposed
- At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion)
- History of emergency visit or admission for asthma in the previous 12 months
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- Use of an investigational drug within 30 days prior to screening
- History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
- History of chronic urticaria within the last year
- History of angioedema
- Any of the following underlying conditions known or suspected to be present:
- Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal, or hepatic insufficiency, chronic infection, drug dependency or alcoholism
- Any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric and ongoing long term treatment with tranquilizer or psychoactive drugs, endocrine, or other major systemic disease or malignancies (including auto-immune diseases, tuberculosis and HIV)).
- Immunosuppressive treatment
- History of allergy, hypersensitivity or intolerance to IMPs (except for Phleum pratense) or desloratadine
- Unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the trial, which in the opinion of the investigator will compromise the data
- Being the investigator, trial staff or their immediate families, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild or being the 2nd member of a family (living in the same household)
- Use of any prohibited drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment.
The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.
Read the detailed description
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The adverse events are considered consistent with the introduction of allergens in sensitised subjects. The majority are local allergic reactions within the mouth and/or throat. Most of these reactions are mild or moderate in intensity, have an onset almost immediately after taking a tablet, and last from minutes to hours after intake. Appearance of adverse events in relation to tablet intake tends to subside spontaneously within 1 to 7 days. Thus, initiation of treatment with Grazax may be associated with discomfort. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. Therefore, the rationale for this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Grazax + Aerius, Grazax + placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grazax + AeriusDrug
Grazax + placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Grazax + Aerius | Active comparator | 1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (desloratidine) 2.5 mg Receives: Drug: Grazax + Aerius |
| Grazax + Placebo | Placebo comparator | 1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (Placebo) Receives: Drug: Grazax + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether intake of antihistamine in connection with Grazax treatment results in a reduction in number of subjects reporting treatment related AEs the first day of Grazax exposure
Measured: 28 days following the first dosing
Secondary outcomes (2)
Other safety endpoint
Vitals signs measured three times (Day 0, Day 14 and Day 28)
Measured: 28 days following first dosing
Other safety endpoint
FEV1 measured three times (Day 0, Day 14 and Day 28)
Measured: 28 Days following the first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740284
- Sponsor's protocol ID
- GT-19
- Acronym
- GT-19
- Status last verified
- Feb 2013
- First submitted
- 14 Nov 2012
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01740284
- Acronym / sponsor ID
- GT-19 / GT-19
- Conditions
- Allergic Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment.
The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.
Detailed description
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The adverse events are considered consistent with the introduction of allergens in sensitised subjects. The majority are local allergic reactions within the mouth and/or throat. Most of these reactions are mild or moderate in intensity, have an onset almost immediately after taking a tablet, and last from minutes to hours after intake. Appearance of adverse events in relation to tablet intake tends to subside spontaneously within 1 to 7 days. Thus, initiation of treatment with Grazax may be associated with discomfort. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. Therefore, the rationale for this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grazax + Aerius | Active comparator | Drug: Grazax + Aerius1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (desloratidine) 2.5 mg |
| Grazax + Placebo | Placebo comparator | Drug: Grazax + placebo1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (Placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 18-65 years of age
- Written informed consent obtained before any clinical trial procedures are performed
- A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- Reporting of treatment related allergic AEs (local reactions in mouth and throat) after intake of Grazax at screening (visit 1)
- Positive skin prick test (SPT) response (wheal diameter ≥ 3 mm larger than the negative control with a flare) to Phleum pratense
Key exclusion criteria (18 listed)
- Uncontrolled asthma in the past 12 months
- FEV1 < 70% of predicted value (calculated according to ECCS (20))
- A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen which might have caused symptoms during the conduct of this trial
- A clinical history of significant symptomatic perennial rhinitis or allergic rhinitis/asthma caused by an allergen to which the subject was regularly exposed
- At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grazax + Aerius | Drug | Grazax + Aerius |
| Grazax + placebo | Drug | Grazax + Placebo |
Primary outcome
To evaluate whether intake of antihistamine in connection with Grazax treatment results in a reduction in number of subjects reporting treatment related AEs the first day of Grazax exposure
Time frame: 28 days following the first dosing
2 secondary outcomes
Other safety endpoint
Time frame: 28 days following first dosing
Other safety endpoint
Time frame: 28 Days following the first dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grazax + Aerius in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in Germany.
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 18 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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
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?
To evaluate whether intake of antihistamine in connection with Grazax treatment results in a reduction in number of subjects reporting treatment related AEs the first day of Grazax exposure (time frame: 28 days following the first dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2013.