AsthmaPhase 2NCT01743768
Safety, Efficacy, PK, and PD Characteristics of Orally Inhaled SB010 in Male Patients With Mild Asthma (Multiple Dose)
A Phase 2 study testing SB010 in people with Asthma, run by Sterna Biologicals GmbH & Co. KG at 7 sites in Germany.
Trial summary
Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent airway obstruction. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Asthma
- What is being tested?
- SB010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 7 sitesGermany
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 2
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adult male Caucasian patients aged ≥ 18 and ≤ 60 years.
- Clinical diagnosis of mild asthma (according to GINA guidelines 2008 update) for at least 6 months prior to screening. No concomitant asthma treatment. except inhaled short-acting bronchodilators.
- Screening FEV1 value of FEV1 ≥ 70 % of the predicted normal value (ECSC) after a wash out of at least 6 hours for inhaled short-acting bronchodilators,
- Patient must demonstrate sufficient induced sputum production.
- Positive skin prick test (skin reactivity) to common aeroallergens (e.g. animal epithelia, dust mite).
- Patient must demonstrate positive allergen-induced early- and late-phase airway bronchoconstriction.
Show all 13Show fewer
- At all timepoints before AC and MCh, patients must show FEV1 not below 65 % predicted.
- Presence of sputum eosinophils either before or after screening allergen challenge (first or second induced sputum).
- Patient has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure.
- Patient is able to understand and give written informed consent and has signed a written informed consent form approved by the Investigator's Research Ethics Board.
- Non-smokers or ex-smokers who had stopped smoking for at least 1 year prior to start of the clinical study with < 10 pack years.
- Ability to inhale in an appropriate manner (patients will be trained to inhale from the AKITA2 APIXNEB® device with a placebo medication at the screening visit).
- Only men who do not want to father children for six months after the last dose of SB010 will be included into this study.
Who cannot join
- Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient's ability to take part in it.
- Presence of relevant pulmonary diseases or history of thoracic surgery, such as:
- known active tuberculosis,
- History of interstitial lung or pulmonary thromboembolic disease,
- Pulmonary resection during the past 12 months,
- History of status asthmaticus,
Show all 37Show fewer
- History of bronchiectasis secondary to respiratory diseases (e.g. cystic fibrosis, Kartagener's syndrome, etc.),
- History of chronic bronchitis, emphysema, allergic bronchopulmonary aspergillosis or respiratory infection within the 4 preceding weeks of the first morning IMP administration.
- Patients on concomitant treatments, except for inhaled short-acting bronchodilators as judged by the investigator.
- Use of short-acting ß2-agonists 6 hours before study visits 2, 3, 4, 5, 11, and 12.
- Hospitalisation or emergency room treatment for acute asthma in the 6 months prior to screening, between screening and the start of the treatment period.
- Intubation (ever) or hospitalisation for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 months of the screening visit.
- History or current evidence of clinically relevant allergies or idiosyncrasy to drugs.
- History of allergic reactions to any active or inactive ingredients of the nebuliser solution.
- ECG abnormalities of clinical relevance.
- Subjects with a resting heart rate < 45 bpm, systolic blood pressure < 100 mmHg, diastolic blood pressure < 60 mmHg.
- Proneness to orthostatic dysregulation, fainting, or blackouts.
- History of malignancy within the past 5 years, except excised basaliomas.
- Clinically relevant abnormalities in clinical chemical, haematological or in any other laboratory variables as judged by the investigator.
- Clinically relevant acute infections in the last 4 weeks preceding AC.
- Clinically relevant chronic infections.
- Positive results in any of the virology tests of acute or chronic infectious human immunodeficiency virus (HIV) and hepatitis B/C virus infections.
- Positive drug screen.
- Abuse of alcohol or drugs.
- Positive cotinine test.
- Treatment with any known enzyme inducing or inhibiting agents (St. John's Wort (Johanniskraut), barbiturates, phenothiazines, cimetidine, ketoconazole etc.) within 30 days before first administration of trial medication or during treatment period of the trial.
- Use of any prohibited concomitant medication within 2 weeks (for biologics: 6 months or 10 times the elimination half-life of the respective drug) before first trial medication administration or within < 10 times the elimination half-life of the respective drug, or the duration of the pharmacodynamic effect, whatever is longer, or anticipated concomitant medication during the treatment period.
- Consumption of any enzyme inducing or inhibiting aliments and beverages (e.g. broccoli, Brussels sprout, grapefruit, grapefruit juice, star fruit etc.) within 14 days prior to the first trial medication administration and during the treatment period of the trial.
- Consumption of any caffeine-containing product 6 hours before first procedure at each study visit.
- Surgery of the gastrointestinal tract which may interfere with drug absorption of swallowed fraction (Note: this is not applicable for minor abdominal surgery such as appendectomy or herniotomy).
- Blood donation within the last 30 days before screening.
- Planned donation of germ cells, blood, organs or bone marrow during the course of the trial or within 6 months thereafter.
- Participation in another clinical trial with an investigational drug or device within the last month or within 10 times the half-life of the respective drug. For biologics the minimum period is at least 6 months or the time of duration of the pharmacodynamic effect or 10 times the half-life of the respective drug before inclusion in this trial.
- Lack of ability or willingness to give informed consent or inability to cooperate adequately.
- Anticipated non-availability for trial visits/procedures.
- Vulnerable subjects (e.g., persons kept in detention).
- Employee at the investigational site, relative or spouse of the investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Charité Research Organisation GmbH
Berlin, D-10117
Clinical Research Centre RespiratoryMedicine (IKF)
Frankfurt, D-60596
Inamed GmbH
Gauting, D-82131
Pulmonary Research Institute (PRI)
Großhansdorf, D-22927
Clinical Airway Research Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Hanover, D-30625
Johannes Gutenberg University Medical Clinic III for Hematology, Oncology and Pneumology
Mainz, D-55131
insaf - Respiratory Research Institute GmbH
Wiesbaden, D-65187
About this study
Official title: Clinical Study to Investigate Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Multiple Doses of the Human GATA-3-specific DNAzyme Solution SB010 in Patients With Mild Allergic Asthma. A Randomised, Double-blind, Parallel, Multicentre, Phase-IIa Study
Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent airway obstruction. One of the characteristics of the disease is an inflammatory reaction of the immune system caused by cytokine production. A substantial number of asthma patients do not satisfactorily respond to steroid therapy and consequently have an unmet medical need for novel targeted therapies with improved specificity, tolerability, and compliance.
Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting early disease-causing mechanisms are a promising approach for the treatment of asthma. The transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and has been shown to be necessary and sufficient for the production of cytokines interleukin (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).
Read more
DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and thereby reduces key features of allergic airway inflammation. DNAzymes are generated completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by use of any living organism including cell culture or bacteria. The molecules are highly water-soluble and will be applied as solution directly in their synthesized form.
This proof-of-concept study will evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of inhaled SB010 in male patients with mild asthma.
- Conditions
- Asthma
- Being tested
- SB010, Placebo
- Keywords
- Antisense oligonucleotide, Asthma, Healthy subjects, Phase 1, Transcription factor GATA-3, Oral inhalation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB010Drug
Also called Active drug substance is hgd40
Treatment group (n=19), receiving the active drug substance.
PlaceboDrug
Also called Phosphate-buffered saline
Treatment group (n=19), receiving placebo.
| Study group | Role | What they receive |
|---|---|---|
| SB010 | Experimental | The drug will be administered in phosphate-buffered saline solution, inhaled over 5 - 10 min, using inhalation device.
Administered dose: 10 mg hgd40 in 2 mL solution (5.0 mg/mL).
Initial dose on Day 1 (single-dose PK profile); once daily dose for 28 consecutive days (Days 1 to 28); last inhalation on Day 28 (steady state PK profile). Receives: Drug: SB010 |
| Placebo | Placebo comparator | The placebo (phosphate-buffered saline) is administered as a solution, inhaled over 5 - 10 min, using inhalation device.
Initial dose on Day 1 (single-dose PK profile); once daily dose for 28 consecutive days (Days 1 to 28); last inhalation on Day 28 (steady state PK profile). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in late phase response after allergen challenge (AC), following multiple doses of inhaled SB010
After 28 days of treatment with SB010 or placebo, patients will undergo allergen bronchoprovocation [allergen challenge (AC)]. The results from AC on Day 28 will be compared to results obtained on Enrolment (Day -1).
Allergen for AC will be selected based on skin prick test performed at Screening. The dose of selected allergen will be determined based on skin prick dilution test.
After the AC, serial spirometry will be used to assess the influence of inhaled SB010 on the area under the Forced Expiratory Volume in 1 second (FEV1) curve during the late asthma response (LAR, 4 - 7 hours); measurement time points will be at 4, 5, 6, and 7 hours after AC.
The spirometric parameters FEV1 and forced vital capacity (FVC), obtained during pulmonary function testing, will be used to derive the primary efficacy variable AUC4-7 FEV1.
Measured: Day -1 and Day 28 (monitoring for 7 h after AC).
Secondary outcomes (5)
Number of patients with adverse events after multiple doses of inhaled SB010
Investigate occurrence of adverse events.
Measured: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in vital signs after multiple doses of inhaled SB010
Investigate any change in vital signs.
Measured: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in electrocardiogram (ECG) after multiple doses of inhaled SB010
Investigate any change in electrocardiogram (ECG).
Measured: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in safety laboratory tests after multiple doses of inhaled SB010
Investigate any change in safety laboratory tests (clinical chemistry, coagulation, immune monitoring, hematology, urine analysis).
Measured: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in spirometry laboratory tests (FEV1, FVC) after multiple doses of inhaled SB010
Investigate the number of patients with changes in spirometry laboratory tests [Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC)], after multiple doses of inhaled SB010.
Measured: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionDec 2013
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sterna Biologicals GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norbert Krug, Prof MD, Principal investigator, Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743768
- Sponsor's protocol ID
- SB010/04/2012
- Other IDs
- 2012-003570-77
- Status last verified
- Mar 2014
- First submitted
- 28 Nov 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krug N, Hohlfeld JM, Kirsten AM, Kornmann O, Beeh KM, Kappeler D, Korn S, Ignatenko S, Timmer W, Rogon C, Zeitvogel J, Zhang N, Bille J, Homburg U, Turowska A, Bachert C, Werfel T, Buhl R, Renz J, Garn H, Renz H. Allergen-induced asthmatic responses modified by a GATA3-specific DNAzyme. N Engl J Med. 2015 May 21;372(21):1987-95. doi: 10.1056/NEJMoa1411776. Epub 2015 May 17.
PubMed 25981191
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Multiple Doses of the Human GATA-3-specific DNAzyme Solution SB010 in Patients With Mild Allergic Asthma. A Randomised, Double-blind, Parallel, Multicentre, Phase-IIa Study
- ClinicalTrials.gov ID
- NCT01743768
- Acronym / sponsor ID
- SB010/04/2012
- Conditions
- Asthma
- Keywords
- Antisense oligonucleotide, Asthma, Healthy subjects, Phase 1, Transcription factor GATA-3, Oral inhalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sterna Biologicals GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Dec 2012 (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.
Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent airway obstruction. One of the characteristics of the disease is an inflammatory reaction of the immune system caused by cytokine production. A substantial number of asthma patients do not satisfactorily respond to steroid therapy and consequently have an unmet medical need for novel targeted therapies with improved specificity, tolerability, and compliance.
Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting early disease-causing mechanisms are a promising approach for the treatment of asthma. The transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and has been shown to be necessary and sufficient for the production of cytokines interleukin (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).
DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and thereby reduces key features of allergic airway inflammation. DNAzymes are generated completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by use of any living organism including cell culture or bacteria. The molecules are highly water-soluble and will be applied as solution directly in their synthesized form.
This proof-of-concept study will evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of inhaled SB010 in male patients with mild asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB010 | Experimental | Drug: SB010The drug will be administered in phosphate-buffered saline solution, inhaled over 5 - 10 min, using inhalation device. Administered dose: 10 mg hgd40 in 2 mL solution (5.0 mg/mL). Initial dose on Day 1 (single-dose PK profile); once daily dose for 28 consecutive days (Days 1 to 28); last inhalation on Day 28 (steady state PK profile). |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo (phosphate-buffered saline) is administered as a solution, inhaled over 5 - 10 min, using inhalation device. Initial dose on Day 1 (single-dose PK profile); once daily dose for 28 consecutive days (Days 1 to 28); last inhalation on Day 28 (steady state PK profile). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adult male Caucasian patients aged ≥ 18 and ≤ 60 years.
- Clinical diagnosis of mild asthma (according to GINA guidelines 2008 update) for at least 6 months prior to screening. No concomitant asthma treatment. except inhaled short-acting bronchodilators.
- Screening FEV1 value of FEV1 ≥ 70 % of the predicted normal value (ECSC) after a wash out of at least 6 hours for inhaled short-acting bronchodilators,
- Patient must demonstrate sufficient induced sputum production.
- Positive skin prick test (skin reactivity) to common aeroallergens (e.g. animal epithelia, dust mite).
Key exclusion criteria (37 listed)
- Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient's ability to take part in it.
- Presence of relevant pulmonary diseases or history of thoracic surgery, such as:
- Patients on concomitant treatments, except for inhaled short-acting bronchodilators as judged by the investigator.
- Use of short-acting ß2-agonists 6 hours before study visits 2, 3, 4, 5, 11, and 12.
- Hospitalisation or emergency room treatment for acute asthma in the 6 months prior to screening, between screening and the start of the treatment period.
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 |
|---|---|---|
| SB010Also: Active drug substance is hgd40Treatment group (n=19), receiving the active drug substance. | Drug | SB010 |
| PlaceboAlso: Phosphate-buffered salineTreatment group (n=19), receiving placebo. | Drug | Placebo |
Primary outcome
Change in late phase response after allergen challenge (AC), following multiple doses of inhaled SB010
Time frame: Day -1 and Day 28 (monitoring for 7 h after AC).
After 28 days of treatment with SB010 or placebo, patients will undergo allergen bronchoprovocation [allergen challenge (AC)]. The results from AC on Day 28 will be compared to results obtained on Enrolment (Day -1). Allergen for AC will be selected based on skin prick test performed at Screening. The dose of selected allergen will be determined based on skin prick dilution test. After the AC, serial spirometry will be used to assess the influence of inhaled SB010 on the area under the Forced Expiratory Volume in 1 second (FEV1) curve during the late asthma response (LAR, 4 - 7 hours); measurement time points will be at 4, 5, 6, and 7 hours after AC. The spirometric parameters FEV1 and forced vital capacity (FVC), obtained during pulmonary function testing, will be used to derive the primary efficacy variable AUC4-7 FEV1.
5 secondary outcomes
Number of patients with adverse events after multiple doses of inhaled SB010
Time frame: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in vital signs after multiple doses of inhaled SB010
Time frame: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in electrocardiogram (ECG) after multiple doses of inhaled SB010
Time frame: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in safety laboratory tests after multiple doses of inhaled SB010
Time frame: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
Number of patients with changes in spirometry laboratory tests (FEV1, FVC) after multiple doses of inhaled SB010
Time frame: Screening examination (Day -56 to -14 before first drug administration); Study period (Day 1 to 28); Follow-up visit (Day 88±4); Maximum of 149 days for a particular subject.
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 20 May 2015.
- Derived from this study: PubMed 25981191Krug N, Hohlfeld JM, Kirsten AM, Kornmann O, Beeh KM, Kappeler D, Korn S, Ignatenko S, Timmer W, Rogon C, Zeitvogel J, Zhang N, Bille J, Homburg U, Turowska A, Bachert C, Werfel T, Buhl R, Renz J, Garn H, Renz H. Allergen-induced asthmatic responses modified by a GATA3-specific DNAzyme. N Engl J Med. 2015 May 21;372(21):1987-95. doi: 10.1056/NEJMoa1411776. Epub 2015 May 17.
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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.
Norbert Krug, Prof MD principal investigator
Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB010 in people with Asthma, run by Sterna Biologicals GmbH & Co. KG at 7 sites 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 13 inclusion and 37 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in late phase response after allergen challenge (AC), following multiple doses of inhaled SB010 (time frame: Day -1 and Day 28 (monitoring for 7 h after AC).). 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 NCT01743768, 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 20 May 2015.