AsthmaPhase 3NCT00504946
Pharmacological Modulations of Allergen-Specific Immunotherapy
A Phase 3 study testing prednisone, lactose, prednisone, colecalciferol, lactose and lactose in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- prednisone, lactose, prednisone, colecalciferol, lactose and lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2005to Mar 2007
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- allergic asthma with regular symptoms requiring long-term treatment with inhaled corticosteroids
- disease duration of at least 2 years
- sensitisation only to house dust mites
- resting FEV1 of more or equal 70%
Who cannot join
- sensitization to allergens other than house dust mites
- discontinuation of SIT from any reasons
- need of a daily dose below 200 or above 800 mcg of budesonide or equivalent
- other chronic disease including vitamin D3 deficiency and/or resistance which 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: inhaled long acting β2-agonist, leukotriene modifiers, β-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study visit.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, 93-513
About this study
Official title: The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy
Read the detailed description
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Since corticosteroids directly induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this effect can be greatly increased with vitamin D3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.
- Conditions
- Asthma
- Being tested
- prednisone, lactose, prednisone, colecalciferol, lactose, lactose, montelukast sodium
- Keywords
- allergen immunotherapy premedication
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisone, lactoseDrug
Also called Miflonide, Pulmicort
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
20mg prednisone+ 0.3mg lactose
prednisone, colecalciferol, lactoseDrug
Also called Miflonide, Pulmicort
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
20mg prednisone + 1000j colecalciferol + 0.3mg lactose
lactoseDrug
Also called Miflonide, Pulmicort
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
0.3mg lactose
montelukast sodiumDrug
Also called Miflonide, Pulmicort
Allergen immunotherapy (build-up phase)premedication with montelukast sodium. Children 6-14 years received 5 mg of montelukast and children > 14 years old received 10mg oral tablet once daily at bedtime
lactoseDrug
Also called Miflonide, Pulmicort
Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Not described Receives: Drug: prednisone, lactose |
| II | Active comparator | Not described Receives: Drug: prednisone, colecalciferol, lactose |
| III | Placebo comparator | Not described Receives: Drug: lactose |
| A | Active comparator | Not described Receives: Drug: montelukast sodium |
| B | Placebo comparator | Not described Receives: Drug: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells
Measured: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
Secondary outcomes (2)
Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture.
Measured: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose
Measured: Visit first and third visit (after 12 months of immunotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startSep 2005
- Primary completionMar 2007
- Study completionMar 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Paweł Majak, MD, PhD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, PolandIwona Stelmach, MD, PhD, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504946
- Sponsor's protocol ID
- RNN-168-05-KE
- Status last verified
- Apr 2008
- First submitted
- 19 Jul 2007
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00504946
- Acronym / sponsor ID
- RNN-168-05-KE
- Conditions
- Asthma
- Keywords
- allergen immunotherapy premedication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 20 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.
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy
Detailed description
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Since corticosteroids directly induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this effect can be greatly increased with vitamin D3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: prednisone, lactose |
| II | Active comparator | Drug: prednisone, colecalciferol, lactose |
| III | Placebo comparator | Drug: lactose |
| A | Active comparator | Drug: montelukast sodium |
| B | Placebo comparator | Drug: lactose |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- allergic asthma with regular symptoms requiring long-term treatment with inhaled corticosteroids
- disease duration of at least 2 years
- sensitisation only to house dust mites
- resting FEV1 of more or equal 70%
Key exclusion criteria (5 listed)
- sensitization to allergens other than house dust mites
- discontinuation of SIT from any reasons
- need of a daily dose below 200 or above 800 mcg of budesonide or equivalent
- other chronic disease including vitamin D3 deficiency and/or resistance which 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: inhaled long acting β2-agonist, leukotriene modifiers, β-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study 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 |
|---|---|---|
| prednisone, lactoseAlso: Miflonide, PulmicortAllergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone+ 0.3mg lactose | Drug | I |
| prednisone, colecalciferol, lactoseAlso: Miflonide, PulmicortAllergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone + 1000j colecalciferol + 0.3mg lactose | Drug | II |
| lactoseAlso: Miflonide, PulmicortAllergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 0.3mg lactose | Drug | III |
| montelukast sodiumAlso: Miflonide, PulmicortAllergen immunotherapy (build-up phase)premedication with montelukast sodium. Children 6-14 years received 5 mg of montelukast and children > 14 years old received 10mg oral tablet once daily at bedtime | Drug | A |
| lactoseAlso: Miflonide, PulmicortAllergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime | Drug | B |
Primary outcome
Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells
Time frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
2 secondary outcomes
Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture.
Time frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose
Time frame: Visit first and third visit (after 12 months of immunotherapy)
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 11 Apr 2008.
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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.
Paweł Majak, MD, PhD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD study chair
Department of Pediatrics and Allergy, Medical University of 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 3 study testing prednisone, lactose, prednisone, colecalciferol, lactose and lactose 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 4 inclusion and 5 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 11 Apr 2008. 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. 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?
Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells (time frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)). 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 11 Apr 2008.