AllergyPhase 2/3NCT00633919
Efficacy of SLITone in House Dust Mite Allergic Patients
A Phase 2/3 study testing SLITone(TM) Dermatophagoides mix, Salbutamol inhaler and Budesonide/formoterol inhaler in people with Allergy, run by ALK-Abelló A/S at 1 site in Spain.
Trial summary
This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- SLITone(TM) Dermatophagoides mix, Salbutamol inhaler and Budesonide/formoterol inhaler
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2006to Feb 2009
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical history of house dust mite induced persistent mild to moderate. asthma, with or without concurrent rhinoconjunctivitis, of at least 1 year of evolution.
- Demonstration of a positive specific serum IgE test to Dermatophagoides during the year prior to the screening visit (CAP Class 2 or higher or equivalent).
- Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Dermatophagoides mix.
- If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test.
- Willingness to comply with this protocol.
Who cannot join
- FEV1 < 70% of predicted value with appropriate medication.
- Asthma controlled at randomization without need of inhaled corticosteroids or with a dose higher than 1000 µg/day of beclometasone or equivalent.
- A clinical history of symptomatic perennial allergic asthma caused by allergens to which the subjects is regularly exposed (Alternaria, cat), other than house dust mites.
- Chronic sinusitis.
- Aspirin or sulfite intolerance.
- Chronic obstructive pulmonary disease.
Show all 17Show fewer
- Current severe atopic dermatitis.
- Severe asthma.
- Use of an investigational drug within 30 days prior to screening.
- Previous immunotherapy with house dust mite allergens for at least 2 years within the previous 10 years.
- At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (se-rous otitis media is not an exclusion criterion).
- Physical examination with clinically relevant findings.
- Any of the following underlying conditions known or suspected to be present: Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alco-holism, ischaemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other ma-jor systemic disease).
- Immunosuppressive treatment.
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
- Unlikely to be able to complete the trial.
- Unwillingness to comply with trial protocol regimen for asthma and/or rhinoconjunctivitis medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial Assessing the Efficacy of SLITone in House Dust Mite Allergic Patients
This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008).
Read the detailed description
This trial was conducted as a multi-centre, randomised, double-blind, parallel-group, placebo-controlled phase III trial, assessing the efficacy of SLITone Dermatophagoides mix in adults (18-65 years). 5 centres in Spain participated.
Subjects with house dust mite allergic asthma were randomised to receive either SLITone Dermatophagoides mix (active) or placebo treatment (1:1) for approximately 1 year. The trial duration was extended to 2 years. Administration was done sublingually (under the tongue) once daily preferably in the morning. A monodose container comprised the daily dose of 200 STU.
Subjects were kept in asthma control during the entire trial (2 years). Except for during 2 evaluation periods of 2 months in autumn 2007 and autumn 2008, subjects used the medications prescribed by their physician. During the 2 evaluation periods of 2 months in autumn 2007 and autumn 2008, subjects used provided and standardised rhinoconjunctivitis and asthma medications. The asthma medication use was to reflect the subject's asthma status. This was done by treatment with a low maintenance dose of control medication supplemented with rescue medication as needed.
Rhinoconjunctivitis medication during the 2 evaluation periods in autumn 2007 and autumn 2008; to standardise the medication used to relieve rhinoconjunctivitis symptoms, subjects were provided with the following free medications as needed:
- Desloratadine tablet (5 mg per tablet; anti-histamine; Aerus®)
- Budesonide nasal spray (64 µg per puff; inhaled corticosteroid)
- Prednisone tablet (5 mg per tablet; oral corticosteroid)
Subjects were instructed to use this medication instead of their usual medication during the 2 evaluation periods in autumn 2007 and autumn 2008, and to record the used medication and symptoms in the daily diary.
Asthma medication during the evaluation period in autumn 2007; prior to the 2 months evaluation period in autumn 2007, the asthma control medication use was interrupted to obtain a medication-free period. Subjects were provided with the following free medications to standardise the treatment used to relieve asthma symptoms:
- Salbutamol inhaler (200 µg per puff; a short acting β2-agonist; Ventilastin®).
- Budesonide/formoterol inhaler (80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting β2-agonist; Symbicort®).
- Prednisone tablet (5 mg per tablet; oral corticosteroid).
Subjects were instructed to use this medication instead of their usual medication during the evaluation period in autumn 2007 as follows:
They were to use salbutamol inhaler as asthma rescue medication until they either:
- needed more than 4 inhalations of salbutamol per day for 2 consecutive days
- suffered from nocturnal asthma forcing them to wake up
- suffered from exercise-induced dyspnoea doing ordinary tasks In these cases, subjects were to contact the investigator to determine the amount of budesonide/formoterol to use as daily asthma control medication. The budesonide/formoterol inhaler was thereafter to be used as rescue medication as needed instead of salbutamol. Prednisone could be used as a last option.
Asthma medication during the evaluation period in autumn 2008: At the 2 months evaluation period in autumn 2008, subjects were maintained at a low dose of budesonide/formoterol (daily asthma control medication) and they used the budesonide/formoterol inhaler as rescue medication as needed. Prednisone could be used as a last option.
Asthma medication used during the evaluation periods in autumn 2007 and autumn 2008 were recorded in a daily diary.
One primary efficacy endpoint and 16 secondary efficacy endpoints were assessed; the result of the primary efficacy endpoint, 3 secondary endpoints and adverse event reportings are posted here. None of the other secondary endpoints demonstrated a difference between treatment groups.
- Conditions
- Allergy
- Being tested
- SLITone(TM) Dermatophagoides mix, Placebo, Salbutamol inhaler, Budesonide/formoterol inhaler, Prednisone tablet
- Keywords
- House dust mites, Sublingual immunotherapy, Allergy, Allergic asthma
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLITone(TM) Dermatophagoides mixBiological
Sublingual immunotherapy with SLITone Dermatophagoides mix (200 STU) once daily for 2 years
PlaceboBiological
Sublingual immunotherapy once daily for 2 years
Salbutamol inhalerDrug
Also called Ventilastin
200 µg per puff; a short acting beta2-agonist (please refer to the 'detailed description' for details on the use)
Budesonide/formoterol inhalerDrug
Also called Symbicort
80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting beta2-agonist (please refer to the 'detailed description' for details on the use)
Prednisone tabletDrug
5 mg per tablet; oral corticosteroids (please refer to the 'detailed description' for details on the use)
Desloratadine tabletDrug
Also called Aerus
5 mg per tablet: anti-histamine (please refer to the 'detailed description' for details on the use)
Budesonide nasal sprayDrug
64 µg per puff; inhaled corticosteroid (please refer to the 'detailed description' for details on the use)
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | SLITone Dermatophagoides Mix Receives: Biological: SLITone(TM) Dermatophagoides mix; Drug: Salbutamol inhaler; Drug: Budesonide/formoterol inhaler; Drug: Prednisone tablet; Drug: Desloratadine tablet; Drug: Budesonide nasal spray |
| Placebo | Placebo comparator | SLITone Placebo Receives: Biological: Placebo; Drug: Salbutamol inhaler; Drug: Budesonide/formoterol inhaler; Drug: Prednisone tablet; Drug: Desloratadine tablet; Drug: Budesonide nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008
Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.
The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).
Measured: 8 weeks
Secondary outcomes (4)
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007
Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.
The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).
Measured: 8 weeks
Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008
The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: "much worse", "worse", "the same", "better", or "much better".
The categories "much better" or "better" were grouped as "improved". The categories "the same", "worse" or "much worse" were grouped as "not improved".
Measured: 8 weeks
Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008
The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: "much worse", "worse", "the same", "better", or "much better".
The categories "much better" or "better" were grouped as "improved". The categories "the same", "worse" or "much worse" were grouped as "not improved".
Measured: 8 weeks
Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007
The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: "much worse", "worse", "the same", "better", or "much better".
The categories "much better" or "better" were grouped as "improved". The categories "the same", "worse" or "much worse" were grouped as "not improved".
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionFeb 2009
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 AllergyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Santiago Martín, PhD, Study chair, Clinical Research Director, ALK-Abelló, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633919
- Sponsor's protocol ID
- E02/04/SLIT1-M
- Other IDs
- EudraCT - 2005-004731-21
- Status last verified
- Jun 2011
- First submitted
- 4 Mar 2008
- Last updated
- 8 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial Assessing the Efficacy of SLITone in House Dust Mite Allergic Patients
- ClinicalTrials.gov ID
- NCT00633919
- Acronym / sponsor ID
- E02/04/SLIT1-M
- Conditions
- Allergy
- Keywords
- House dust mites, Sublingual immunotherapy, Allergy, Allergic asthma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 21 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008).
Detailed description
This trial was conducted as a multi-centre, randomised, double-blind, parallel-group, placebo-controlled phase III trial, assessing the efficacy of SLITone Dermatophagoides mix in adults (18-65 years). 5 centres in Spain participated.
Subjects with house dust mite allergic asthma were randomised to receive either SLITone Dermatophagoides mix (active) or placebo treatment (1:1) for approximately 1 year. The trial duration was extended to 2 years. Administration was done sublingually (under the tongue) once daily preferably in the morning. A monodose container comprised the daily dose of 200 STU.
Subjects were kept in asthma control during the entire trial (2 years). Except for during 2 evaluation periods of 2 months in autumn 2007 and autumn 2008, subjects used the medications prescribed by their physician. During the 2 evaluation periods of 2 months in autumn 2007 and autumn 2008, subjects used provided and standardised rhinoconjunctivitis and asthma medications. The asthma medication use was to reflect the subject's asthma status. This was done by treatment with a low maintenance dose of control medication supplemented with rescue medication as needed.
Rhinoconjunctivitis medication during the 2 evaluation periods in autumn 2007 and autumn 2008; to standardise the medication used to relieve rhinoconjunctivitis symptoms, subjects were provided with the following free medications as needed:
- Desloratadine tablet (5 mg per tablet; anti-histamine; Aerus®)
- Budesonide nasal spray (64 µg per puff; inhaled corticosteroid)
- Prednisone tablet (5 mg per tablet; oral corticosteroid)
Subjects were instructed to use this medication instead of their usual medication during the 2 evaluation periods in autumn 2007 and autumn 2008, and to record the used medication and symptoms in the daily diary.
Asthma medication during the evaluation period in autumn 2007; prior to the 2 months evaluation period in autumn 2007, the asthma control medication use was interrupted to obtain a medication-free period. Subjects were provided with the following free medications to standardise the treatment used to relieve asthma symptoms:
- Salbutamol inhaler (200 µg per puff; a short acting β2-agonist; Ventilastin®).
- Budesonide/formoterol inhaler (80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting β2-agonist; Symbicort®).
- Prednisone tablet (5 mg per tablet; oral corticosteroid).
Subjects were instructed to use this medication instead of their usual medication during the evaluation period in autumn 2007 as follows:
They were to use salbutamol inhaler as asthma rescue medication until they either:
- needed more than 4 inhalations of salbutamol per day for 2 consecutive days
- suffered from nocturnal asthma forcing them to wake up
- suffered from exercise-induced dyspnoea doing ordinary tasks In these cases, subjects were to contact the investigator to determine the amount of budesonide/formoterol to use as daily asthma control medication. The budesonide/formoterol inhaler was thereafter to be used as rescue medication as needed instead of salbutamol. Prednisone could be used as a last option.
Asthma medication during the evaluation period in autumn 2008: At the 2 months evaluation period in autumn 2008, subjects were maintained at a low dose of budesonide/formoterol (daily asthma control medication) and they used the budesonide/formoterol inhaler as rescue medication as needed. Prednisone could be used as a last option.
Asthma medication used during the evaluation periods in autumn 2007 and autumn 2008 were recorded in a daily diary.
One primary efficacy endpoint and 16 secondary efficacy endpoints were assessed; the result of the primary efficacy endpoint, 3 secondary endpoints and adverse event reportings are posted here. None of the other secondary endpoints demonstrated a difference between treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Biological: SLITone(TM) Dermatophagoides mix, Drug: Salbutamol inhaler, Drug: Budesonide/formoterol inhaler, Drug: Prednisone tablet, Drug: Desloratadine tablet, Drug: Budesonide nasal spraySLITone Dermatophagoides Mix |
| Placebo | Placebo comparator | Biological: Placebo, Drug: Salbutamol inhaler, Drug: Budesonide/formoterol inhaler, Drug: Prednisone tablet, Drug: Desloratadine tablet, Drug: Budesonide nasal spraySLITone Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical history of house dust mite induced persistent mild to moderate. asthma, with or without concurrent rhinoconjunctivitis, of at least 1 year of evolution.
- Demonstration of a positive specific serum IgE test to Dermatophagoides during the year prior to the screening visit (CAP Class 2 or higher or equivalent).
- Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Dermatophagoides mix.
- If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test.
- Willingness to comply with this protocol.
Key exclusion criteria (17 listed)
- FEV1 < 70% of predicted value with appropriate medication.
- Asthma controlled at randomization without need of inhaled corticosteroids or with a dose higher than 1000 µg/day of beclometasone or equivalent.
- A clinical history of symptomatic perennial allergic asthma caused by allergens to which the subjects is regularly exposed (Alternaria, cat), other than house dust mites.
- Chronic sinusitis.
- Aspirin or sulfite intolerance.
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 |
|---|---|---|
| SLITone(TM) Dermatophagoides mixSublingual immunotherapy with SLITone Dermatophagoides mix (200 STU) once daily for 2 years | Biological | Active |
| PlaceboSublingual immunotherapy once daily for 2 years | Biological | Placebo |
| Salbutamol inhalerAlso: Ventilastin200 µg per puff; a short acting beta2-agonist (please refer to the 'detailed description' for details on the use) | Drug | Active, Placebo |
| Budesonide/formoterol inhalerAlso: Symbicort80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting beta2-agonist (please refer to the 'detailed description' for details on the use) | Drug | Active, Placebo |
| Prednisone tablet5 mg per tablet; oral corticosteroids (please refer to the 'detailed description' for details on the use) | Drug | Active, Placebo |
| Desloratadine tabletAlso: Aerus5 mg per tablet: anti-histamine (please refer to the 'detailed description' for details on the use) | Drug | Active, Placebo |
| Budesonide nasal spray64 µg per puff; inhaled corticosteroid (please refer to the 'detailed description' for details on the use) | Drug | Active, Placebo |
Primary outcome
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008
Time frame: 8 weeks
Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40. The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).
4 secondary outcomes
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007
Time frame: 8 weeks
Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008
Time frame: 8 weeks
Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008
Time frame: 8 weeks
Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- 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.
Santiago Martín, PhD study chair
Clinical Research Director, ALK-Abelló, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SLITone(TM) Dermatophagoides mix, Salbutamol inhaler and Budesonide/formoterol inhaler in people with Allergy, 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 5 inclusion and 17 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 8 Jun 2011. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Feb 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?
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008 (time frame: 8 weeks). 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 8 Jun 2011.