Allergic AsthmaPhase 4NCT00492076
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
A Phase 4 study testing Pangramin Plus D. pteronyssinus 100% in people with Allergic Asthma, run by ALK-Abelló A/S at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Pangramin Plus D. pteronyssinus 100%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2006to May 2008
- 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 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild/moderate persistent asthma
- Positive skin prick test or specific IgE to mites
- Age: 14-55 years old
Who cannot join
- Immunotherapy contraindications
- Allergy to other inhalant allergens
- Previous immunotherapy (5 years)with mites
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Virgen del Camino, Allergology Service
Pamplona, Navarre, 31002
About this study
Official title: A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma
The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.
Read the detailed description
The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.
- Conditions
- Allergic Asthma
- Being tested
- Pangramin Plus D. pteronyssinus 100%
- Keywords
- Specific immunotherapy, Mite, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pangramin Plus D. pteronyssinus 100%Biological
- Active. Pangramin Plus D. pteronyssinus 100%
- Placebo. Pangramin Plus placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pangramin Plus Dermatophagoides pteronyssinus 100% Receives: Biological: Pangramin Plus D. pteronyssinus 100% |
| 2 | Placebo comparator | Pangramin Plus placebo Receives: Biological: Pangramin Plus D. pteronyssinus 100% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in inhaled corticosteroids
Measured: 4 months
Secondary outcomes (1)
Reduction in symptoms and rescue medication Tolerability
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ana I Tabar, MD PhD, Principal investigator, Hospital Virgen del Camino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492076
- Sponsor's protocol ID
- E04/05/PP-M
- Status last verified
- Oct 2008
- First submitted
- 26 Jun 2007
- Last updated
- 16 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma
- ClinicalTrials.gov ID
- NCT00492076
- Acronym / sponsor ID
- E04/05/PP-M
- Conditions
- Allergic Asthma
- Keywords
- Specific immunotherapy, Mite, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Jun 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 purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.
Detailed description
The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Pangramin Plus D. pteronyssinus 100%Pangramin Plus Dermatophagoides pteronyssinus 100% |
| 2 | Placebo comparator | Biological: Pangramin Plus D. pteronyssinus 100%Pangramin Plus placebo |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Mild/moderate persistent asthma
- Positive skin prick test or specific IgE to mites
- Age: 14-55 years old
Key exclusion criteria (3 listed)
- Immunotherapy contraindications
- Allergy to other inhalant allergens
- Previous immunotherapy (5 years)with mites
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 |
|---|---|---|
| Pangramin Plus D. pteronyssinus 100%1. Active. Pangramin Plus D. pteronyssinus 100% 2. Placebo. Pangramin Plus placebo | Biological | 1, 2 |
Primary outcome
Reduction in inhaled corticosteroids
Time frame: 4 months
1 secondary outcome
Reduction in symptoms and rescue medication Tolerability
Time frame: 4 months
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 16 Oct 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.
Ana I Tabar, MD PhD principal investigator
Hospital Virgen del Camino
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 Pangramin Plus D. pteronyssinus 100% in people with Allergic Asthma, run by ALK-Abelló A/S at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 16 Oct 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 Spain. 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 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?
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?
Reduction in inhaled corticosteroids (time frame: 4 months). 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 16 Oct 2008.