AsthmaPhase 4NCT00496574
Evaluation of Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma
A Phase 4 study testing Novo Helisen Depot, Phostal in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Novo Helisen Depot, Phostal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- May 2006to Dec 2013
- Phase
- Phase 4
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients allergic to house dust mites
- patients with moderate bronchial asthma
- patients with controlled asthma
- patients who were qualified for immunotherapy and gave written informed consent for immunotherapy (active treatment group)
- patients who were qualified for immunotherapy and did not agree with this kind of treatment - did not give written informed consent for immunotherapy (control group)
Who cannot join
- patients allergic for other perennial and seasonal allergens
- patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
- medications that resulted in patient exclusion included:anti-parasites or oral corticosteroids within 6 months before the first visit.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, 93-513
Agnieszka Sobocińska, MD, 00 48 42 6895972, alergol@kopernik.lodz.pl
Iwona Stelmach, MD PhD Prof
About this study
Official title: Evaluation of Long-term Clinical Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.
Read the detailed description
According to Global Initiative for Asthma treatment of asthma is based on avoidance of allergens, pharmacological treatment, and specific immunotherapy.
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.
- Conditions
- Asthma
- Being tested
- Novo Helisen Depot, Phostal
- Keywords
- asthma, immunotherapy, efficacy, children, symptoms score, quality of life, spirometry, PC20M
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novo Helisen Depot, PhostalBiological
Also called Novo Helisen Depot
subcutaneous immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Biological: Novo Helisen Depot, Phostal |
| 2 | No intervention | no intevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function
Measured: baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit)
Secondary outcomes (1)
bronchial hyperreactivity with methacholine, and presence and type of allergy after tree years of SIT in children with asthma.
Measured: after 36 months (fourth visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startMay 2006
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Stelmach, Medical University of Lodz
- Investigators
- Agnieszka Sobocińska, MD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, PolandIwona Stelmach, MD PhD Prof, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496574
- Sponsor's protocol ID
- RNN-102-06-KE
- Status last verified
- Feb 2013
- First submitted
- 3 Jul 2007
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Clinical Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma
- ClinicalTrials.gov ID
- NCT00496574
- Acronym / sponsor ID
- RNN-102-06-KE
- Conditions
- Asthma
- Keywords
- asthma, immunotherapy, efficacy, children, symptoms score, quality of life, spirometry, PC20M
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Jul 2007 (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.
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.
Detailed description
According to Global Initiative for Asthma treatment of asthma is based on avoidance of allergens, pharmacological treatment, and specific immunotherapy.
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Novo Helisen Depot, Phostal |
| 2 | No intervention | –no intevention |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- patients allergic to house dust mites
- patients with moderate bronchial asthma
- patients with controlled asthma
- patients who were qualified for immunotherapy and gave written informed consent for immunotherapy (active treatment group)
- patients who were qualified for immunotherapy and did not agree with this kind of treatment - did not give written informed consent for immunotherapy (control group)
Key exclusion criteria (3 listed)
- patients allergic for other perennial and seasonal allergens
- patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
- medications that resulted in patient exclusion included:anti-parasites or oral corticosteroids within 6 months before the first visit.
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 |
|---|---|---|
| Novo Helisen Depot, PhostalAlso: Novo Helisen Depotsubcutaneous immunotherapy | Biological | 1 |
Primary outcome
clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function
Time frame: baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit)
1 secondary outcome
bronchial hyperreactivity with methacholine, and presence and type of allergy after tree years of SIT in children with asthma.
Time frame: after 36 months (fourth visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Agnieszka Sobocińska, MD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
Iwona Stelmach, MD PhD Prof study chair
Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Novo Helisen Depot, Phostal in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
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 5 inclusion and 3 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 7 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 Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Agnieszka Sobocińska, MD (00 48 42 6895972, alergol@kopernik.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function (time frame: baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit)). 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 7 Feb 2013.