Allergic AsthmaPhase 3NCT00396409
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
A Phase 3 study testing Depigoid and Omalizumab in people with Allergic Asthma, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Depigoid and Omalizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing)
- Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within > 2 previous seasons
- patients with a positive RAST (>CAP2) result for grass pollen (and/or rye pollen) specific IgE at screening (Visit 1 (V1) or within the previous 12 months.
- Patients with FEV1 > 80% of the predicted normal value for the patient at screening [V1](demostrable at least 6 hours after last short acting B-2 agonist use or 12 hours after last long B-2 acting agonist use).
Who cannot join
- Females of childbearing potential: pregnancy, birth control,breast-feeding
- Concurrent diseases/conditions and history of other diseases/conditions
- patients who have a positive history of significant clinical manifestations of allergy as a result of sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite).
- patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
- Ingredient hypersensitivity
- patients with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication, any immunotherapy, or drugs related to Omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
- patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, 20 Week, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Combination With Depigoid, Versus Depigoid Only, in Adult and Adolescent Patients With Seasonal Allergic Asthma and Comorbid Seasonal Allergic Rhinoconjunctivitis - Open-label Depigoid Monotherapy Extension Periods 2007 and 2008-
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.
Read the detailed description
This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.
This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.
- Conditions
- Allergic Asthma
- Being tested
- Depigoid, Omalizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepigoidDrug
Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)
OmalizumabDrug
Also called Xolair
anti-IgE (Omalizumab) given during the 2006 core study
PlaceboDrug
Placebo given during the 2006 core study
| Study group | Role | What they receive |
|---|---|---|
| Depigold+Omalizumab | Experimental | Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) Receives: Drug: Depigoid; Drug: Omalizumab |
| Depigoid+Placebo | Experimental | Depigoid® (grass/rye pollen 50/50) + Placebo Receives: Drug: Depigoid; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Symptom Load
The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.
Measured: Recorded daily during the 2007 and 2008 pollen season
Secondary outcomes (11)
Asthma/Rhinoconjunctivitis Symptom Severity Score
The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome.
Measured: Recorded daily during the 2007 and 2008 pollen season
Asthma/Rhinoconjunctivitis Rescue Medication Score
Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient's entries in their diaries.
Measured: Recorded daily during the 2007 and 2008 pollen season
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing').
Measured: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing').
Measured: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Asthma Control Questionnaire (ACQ)
The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively.
Measured: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life.
Measured: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life.
Measured: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
Measured: Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Work Productivity and Activity Impairment
The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner.
Measured: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)
The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid.
Measured: Assist during 2007 and 2008 pollen season
Lung Function as Assessed by Peak Expiratory Flow (PEF)
The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced.
Measured: Assist during 2007 and 2008 pollen season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startFeb 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals, Basel +41 61 324 1111.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396409
- Sponsor's protocol ID
- CIGE025ADE03
- Status last verified
- Feb 2017
- First submitted
- 6 Nov 2006
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 20 Week, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Combination With Depigoid, Versus Depigoid Only, in Adult and Adolescent Patients With Seasonal Allergic Asthma and Comorbid Seasonal Allergic Rhinoconjunctivitis - Open-label Depigoid Monotherapy Extension Periods 2007 and 2008-
- ClinicalTrials.gov ID
- NCT00396409
- Acronym / sponsor ID
- CIGE025ADE03
- Conditions
- Allergic Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Nov 2006 (estimated)
- Results
- Posted 3 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.
Detailed description
This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.
This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depigold+Omalizumab | Experimental | Drug: Depigoid, Drug: OmalizumabXolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) |
| Depigoid+Placebo | Experimental | Drug: Depigoid, Drug: PlaceboDepigoid® (grass/rye pollen 50/50) + Placebo |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing)
- Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within > 2 previous seasons
- patients with a positive RAST (>CAP2) result for grass pollen (and/or rye pollen) specific IgE at screening (Visit 1 (V1) or within the previous 12 months.
- Patients with FEV1 > 80% of the predicted normal value for the patient at screening [V1](demostrable at least 6 hours after last short acting B-2 agonist use or 12 hours after last long B-2 acting agonist use).
Key exclusion criteria (7 listed)
- Females of childbearing potential: pregnancy, birth control,breast-feeding
- Concurrent diseases/conditions and history of other diseases/conditions
- Ingredient hypersensitivity
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 |
|---|---|---|
| DepigoidAdministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL) | Drug | Depigoid+Placebo, Depigold+Omalizumab |
| OmalizumabAlso: Xolairanti-IgE (Omalizumab) given during the 2006 core study | Drug | Depigold+Omalizumab |
| PlaceboPlacebo given during the 2006 core study | Drug | Depigoid+Placebo |
Primary outcome
Daily Symptom Load
Time frame: Recorded daily during the 2007 and 2008 pollen season
The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.
11 secondary outcomes
Asthma/Rhinoconjunctivitis Symptom Severity Score
Time frame: Recorded daily during the 2007 and 2008 pollen season
Asthma/Rhinoconjunctivitis Rescue Medication Score
Time frame: Recorded daily during the 2007 and 2008 pollen season
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
Time frame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
Time frame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Asthma Control Questionnaire (ACQ)
Time frame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
Time frame: Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Work Productivity and Activity Impairment
Time frame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)
Time frame: Assist during 2007 and 2008 pollen season
Lung Function as Assessed by Peak Expiratory Flow (PEF)
Time frame: Assist during 2007 and 2008 pollen season
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 chair
Novartis Pharmaceuticals, Basel +41 61 324 1111.
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 Depigoid and Omalizumab in people with Allergic Asthma, run by Novartis Pharmaceuticals 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 4 inclusion and 7 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 30 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 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. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daily Symptom Load (time frame: Recorded daily during the 2007 and 2008 pollen season). 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 30 Mar 2017.