Respiratory HypersensitivityPhase 3NCT00263640
Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma
A Phase 3 study testing Acaroid in people with Respiratory Hypersensitivity, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma. Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Respiratory Hypersensitivity
- What is being tested?
- Acaroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Aug 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 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Bronchial asthma
- Requirements for inhaled corticosteroid
- Positive skin prick test to house dust mite
- Positive radioallergosorbent test (RAST) to house dust mite
- Positive provocation test result to house dust mite
Who cannot join
- Serious chronic diseases
- Other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Alum.-Adsorbed Allergoid Preparation of House Dust Mite (D. Pteronyssinus) in Patients With Allergic Bronchial Asthma, Rhinitis, Rhinoconjunctivitis
The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.
Read the detailed description
The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.
- Conditions
- Respiratory Hypersensitivity
- Being tested
- Acaroid, Placebo
- Keywords
- House dust mite, Bronchial Asthma, Allergy, House Dust Mite Allergy
- Medical subject headings
- Respiratory Hypersensitivity, Asthma, Hypersensitivity, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcaroidBiological
Also called Specific Immunotherapy
The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.
PlaceboDrug
Also called Comparator
Placebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling. Receives: Drug: Placebo |
| Acaroid | Experimental | The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses. Receives: Biological: Acaroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhalative dose of fluticasone propionate
The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.
Measured: After 2 years
Secondary outcomes (1)
Pre-bronchodilator morning peak flow
Post treatment, the changes from baseline in the mean pre-bronchodilator morning peak flow during the last two weeks of the diary phases were determined.
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startMay 2005
- Primary completionApr 2009
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory HypersensitivityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annemie Narkus, M.D., Principal investigator, Allergopharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263640
- Sponsor's protocol ID
- Al0104av
- Other IDs
- 2004-003892-35, 2004
- Status last verified
- Jan 2015
- First submitted
- 8 Dec 2005
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10.
PubMed 20624650
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Alum.-Adsorbed Allergoid Preparation of House Dust Mite (D. Pteronyssinus) in Patients With Allergic Bronchial Asthma, Rhinitis, Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00263640
- Acronym / sponsor ID
- Al0104av
- Conditions
- Respiratory Hypersensitivity
- Keywords
- House dust mite, Bronchial Asthma, Allergy, House Dust Mite Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Dec 2005 (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 trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.
Detailed description
The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling. |
| Acaroid | Experimental | Biological: AcaroidThe drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Bronchial asthma
- Requirements for inhaled corticosteroid
- Positive skin prick test to house dust mite
- Positive radioallergosorbent test (RAST) to house dust mite
- Positive provocation test result to house dust mite
Key exclusion criteria (2 listed)
- Serious chronic diseases
- Other perennial allergies
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 |
|---|---|---|
| AcaroidAlso: Specific ImmunotherapyThe drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses. | Biological | Acaroid |
| PlaceboAlso: ComparatorPlacebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling. | Drug | Placebo |
Primary outcome
Inhalative dose of fluticasone propionate
Time frame: After 2 years
The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.
1 secondary outcome
Pre-bronchodilator morning peak flow
Time frame: After 2 years
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 15 Jan 2015.
- Results publication: PubMed 20624650Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10.
- Leader in specific allergy research and therapyLink provided by the sponsor.
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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.
Annemie Narkus, M.D. principal investigator
Allergopharma GmbH & Co. KG
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 Acaroid in people with Respiratory Hypersensitivity, run by Allergopharma GmbH & Co. KG 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 5 inclusion and 2 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 15 Jan 2015. 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. 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?
Inhalative dose of fluticasone propionate (time frame: After 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263640, which also lists 1 linked publication.
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 15 Jan 2015.