Allergic RhinoconjunctivitisPhase 3INSIDENCT01902992
Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch
A Phase 3 study testing Depiquick Birch (DPG103) in people with Allergic Rhinoconjunctivitis, run by Novartis at 35 sites in Germany.
Trial summary
This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Depiquick Birch (DPG103)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 35 sitesGermany
- Study dates
- Mar 2012to Jul 2012
- 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 must experience significant allergic symptoms on visit 2
- Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens
- Specific IgE against birch allergens (CAP RAST ≥ 2)
Who cannot join
- History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens
- FEV1 or PEF value ≤ 80 %
- Persistent asthma (GINA ≥ 2)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Germany35 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Augsburg, 86179
Novartis Investigative Site
Bad Wildbad, 75323
Novartis Investigative Site
Bad Wörishofen, 86825
Novartis Investigative Site
Bensheim, 64625
Novartis Investigative Site
Berlin, 13057
Novartis Investigative Site
Berlin, 13187
Novartis Investigative Site
Berlin, 14050
Novartis Investigative Site
Bochum, 44803
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Chemnitz, 09130
Novartis Investigative Site
Delitzsch, 04509
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Duisburg, 47051
Novartis Investigative Site
Dülmen, 48249
Novartis Investigative Site
Frankfurt, 60389
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Hanover, 30159
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04275
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Münster, 48143
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Neunkirchen, 66538
Novartis Investigative Site
Nidderau, 61130
Novartis Investigative Site
Oberhausen, 46145
Novartis Investigative Site
Osnabrück, 49074
Novartis Investigative Site
Rodgau, 63110
Novartis Investigative Site
Wallenhorst, 49134
Novartis Investigative Site
Wiesbaden, 64191
Novartis Investigative Site
Wiesbaden, 65183
Novartis Investigative Site
Witten, 58452
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Intraseasonal Specific Short-term Immunotherapy With Depigmented Glutaraldehyde Polymerized Birch Pollen Allergenic Extract (Depiquick® Birch) in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma
This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Depiquick Birch (DPG103), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depiquick Birch (DPG103)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Depiquick® Birch | Experimental | At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. Receives: Drug: Depiquick Birch (DPG103) |
| Placebo | Placebo comparator | At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Symptom and Medication Score (SMS)
The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The rescue medication score is defined as the mean of the daily rescue medication scores during the pollen season. A lower score indicates an improvement in the allergic condition. Minimum score of the SMS is "0", maximum score is dependent on intake of rescue medication.
Measured: From the start of treatment until the end of the relevant pollen exposition time.
Secondary outcomes (3)
Combined Symptom and Medication Score (SMS)
The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The overall severity rhinitis/rhinoconjunctivitis (including nasal itching, sneezing, rhinorrhea, nasal obstruction, ocular itching/grittiness/redness, and ocular tearing) and asthma (including chest tightness, shortness of breath, cough, wheezing) will be evaluated by the patient daily
Measured: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Onset of action (patient's assessment)
Patients will document the point in time when they experience onset of action of the therapy by answering the question "Do you have the feeling that your allergy symptoms are better or less due to SIT today?" with "Yes" or "No".
Measured: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)
The RQLQ is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinitis/rhinoconjunctivitis (Juniper and Guyatt 1991). It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions).
Measured: Visits 2, 4, 6, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 2012
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902992
- Sponsor's protocol ID
- CDPG103ADE01
- Other IDs
- 2011-004185-14
- Acronym
- INSIDE
- Status last verified
- Mar 2017
- First submitted
- 28 Oct 2011
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Intraseasonal Specific Short-term Immunotherapy With Depigmented Glutaraldehyde Polymerized Birch Pollen Allergenic Extract (Depiquick® Birch) in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma
- ClinicalTrials.gov ID
- NCT01902992
- Acronym / sponsor ID
- INSIDE / CDPG103ADE01
- Conditions
- Allergic Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Jul 2013 (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.
This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depiquick® Birch | Experimental | Drug: Depiquick Birch (DPG103)At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. |
| Placebo | Placebo comparator | Drug: PlaceboAt the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must experience significant allergic symptoms on visit 2
- Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens
- Specific IgE against birch allergens (CAP RAST ≥ 2)
Key exclusion criteria (4 listed)
- History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens
- FEV1 or PEF value ≤ 80 %
- Persistent asthma (GINA ≥ 2)
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Depiquick Birch (DPG103) | Drug | Depiquick® Birch |
| Placebo | Drug | Placebo |
Primary outcome
Combined Symptom and Medication Score (SMS)
Time frame: From the start of treatment until the end of the relevant pollen exposition time.
The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The rescue medication score is defined as the mean of the daily rescue medication scores during the pollen season. A lower score indicates an improvement in the allergic condition. Minimum score of the SMS is "0", maximum score is dependent on intake of rescue medication.
3 secondary outcomes
Combined Symptom and Medication Score (SMS)
Time frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Onset of action (patient's assessment)
Time frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)
Time frame: Visits 2, 4, 6, and 7
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 22 Mar 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depiquick Birch (DPG103) in people with Allergic Rhinoconjunctivitis, run by Novartis at 35 sites 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 3 inclusion and 4 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites 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?
Combined Symptom and Medication Score (SMS) (time frame: From the start of treatment until the end of the relevant pollen exposition time.). 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 22 Mar 2017.