AsthmaPhase 2NCT00394654
A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma
A Phase 2 study testing MEDI-528 9 mg/kg in people with Asthma, run by MedImmune LLC at 3 sites in Canada.
Trial summary
This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- MEDI-528 9 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2006to Jan 2008
- Phase
- Phase 2
- 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
- Male or female adults, age 18 through 65 years of age at the time of screening;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
- Previously documented diagnosis of asthma of > 1 year duration, based on episodic symptoms of airflow obstruction, at least partial reversibility of airflow obstruction, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
- AHR in the methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) ≤ 16 mg/mL (Crapo, 2000);
- Have dual response of EAR, defined as a decrease in FEV1 ≥ 20% at 0 to 3 hours after inhalation, and LAR, defined as a decrease in FEV1 ≥ 15% 3 to 7 hours after inhalation, to inhaled allergen;
- Asthma symptoms are adequately controlled on short-acting β2 agonists (e.g., albuterol) alone;
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- Have had no significant changes in regular asthma medications and no acute asthma exacerbations requiring corticosteroid rescue, hospitalization, or emergency department visits for at least 4 weeks prior to screening and up through the time of the first dose of study drug on Study Day 0.
- Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug on Study Day 0, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 126;
- Able to complete the follow-up period through Study Day 126, as required by the protocol.
- Willing to forego other forms of experimental treatment and study procedures during the study; and
- Able to provide spirometric readings that meet American Thoracic Society (ATS) standards (ATS, 1995).
Who cannot join
- Receipt of MEDI-528 in any previous clinical study;
- History of allergy or adverse reactions to any component of the MEDI-528 formulation;
- Lung disease other than allergic asthma (e.g. chronic bronchitis);
- Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting β2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting β2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0.
- Current use of any β-adrenergic antagonist (e.g. propranolol).
- Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
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- Acute illnesses or evidence of clinically significant active infection, such as fever ³ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0;
- Current allergy-vaccination therapy (i.e., desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline allergen inhalation challenge;
- Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
- Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
- Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
- Is a nursing mother at the time of study enrollment;
- Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A;
- History of significant systemic disease (e.g., cancer; infection; coronary artery disease or other cardiovascular disease; or hematological, renal, hepatic, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
- History of cancer other than nonmelanoma skin cancer or cervical carcinoma-in-situ that have been treated successfully with curative therapy;
- History of primary immunodeficiency;
- History of pancreatitis;
- History of use of tobacco products within 2 years of baseline or history of smoking >= 10 pack-years;
- Elective surgery planned from the time of screening through Study Day 126;
- Clinically significant abnormalities (other than asthma) upon physical examination prior to study drug administration on Study Day 0;
- Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at the time of screening;
- At the time of screening, any of the following abnormalities: aspartate transaminase (AST), alanine transaminase (ALT), or amylase > 1.5 × above the upper limits of normal (ULN); or serum creatinine > 1.3 × ULN; or any other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator (PI), are judged to be clinically significant; or
- Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the PI or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University
Hamilton, Ontario, L8N 3Z5
Hopital Laval
Québec, Quebec, G1V 4G5
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy of MEDI-528, a Humanized Anti-Interleukin-9 Monoclonal Antibody, on Late Asthmatic Response Induced By Allergen Inhalation In Adults With Atopic Asthma
This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.
Read the detailed description
This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.
- Conditions
- Asthma
- Being tested
- MEDI-528 9 mg/kg, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-528 9 mg/kgBiological
MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion
PlaceboOther
Placebo administered as a single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| MEDI528 9 mg/kg | Experimental | MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion Receives: Biological: MEDI-528 9 mg/kg |
| PLACEBO | Placebo comparator | Placebo administered as a single intravenous infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7
Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.
Measured: Day 7
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Measured: Day 28
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Measured: Day 56
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7
Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Measured: Day 7
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Measured: Day 28
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Measured: Day 56
Secondary outcomes (23)
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Measured: Days 0 - 126
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Measured: Days 0 - 126
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants with ADA to MEDI-528
Measured: Days 0, 27, 55, 84, and 126
Time to Observed Maximum Serum Concentration (Tmax)
Tmax of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Time to Observed Maximum Sputum Concentration (Tmax)
Tmax of MEDI-528 in sputum
Measured: Days -21 to -7, 7, 28, and 56
Time to Observed Maximum Nasal Lavage Concentration (Tmax)
Tmax of MEDI-528 in nasal lavage
Measured: Days -6 to -1, 8, 29, and 57
Observed Maximum Serum Concentration (Cmax)
Cmax of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Observed Maximum Sputum Concentration (Cmax)
Cmax of MEDI-528 in sputum
Measured: Days -21 to -7, 7, 28, and 56
Observed Maximum Nasal Lavage Concentration (Cmax)
Cmax of MEDI-528 in nasal lavage
Measured: Days -6 to -1, 8, 29, and 57
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in sputum
Measured: Days -21 to -7, 7, 28, and 56
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in nasal lavage
Measured: Days -6 to -1, 8, 29, and 57
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in sputum
Measured: Days -21 to -7, 7, 28, and 56
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in nasal lavage
Measured: Days -6 to -1, 8, 29, and 57
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in sputum
Measured: Days -21 to -7, 7, 28, and 56
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in nasal lavage
Measured: Days -6 to -1, 8, 29, and 57
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in sputum
Measured: Days -21 to -7, 7, 28, and 56
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in nasal lavage
Measured: Days -6 to -1, 8, 29, and 57
Total Body Clearance (CL)
CL of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Terminal Phase Volume of Distribution (Vz)
Vz of MEDI-528 in serum
Measured: Days 0, 6, 7, 27, 55, 84, and 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionAug 2007
- Study completionJan 2008
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nestor Molfino, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394654
- Sponsor's protocol ID
- MI-CP138
- Other IDs
- NCT00394654
- Status last verified
- Oct 2013
- First submitted
- 31 Oct 2006
- Last updated
- 11 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy of MEDI-528, a Humanized Anti-Interleukin-9 Monoclonal Antibody, on Late Asthmatic Response Induced By Allergen Inhalation In Adults With Atopic Asthma
- ClinicalTrials.gov ID
- NCT00394654
- Acronym / sponsor ID
- MI-CP138
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 1 Nov 2006 (estimated)
- Results
- Posted 11 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.
Detailed description
This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI528 9 mg/kg | Experimental | Biological: MEDI-528 9 mg/kgMEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion |
| PLACEBO | Placebo comparator | Other: PlaceboPlacebo administered as a single intravenous infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female adults, age 18 through 65 years of age at the time of screening;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
- Previously documented diagnosis of asthma of > 1 year duration, based on episodic symptoms of airflow obstruction, at least partial reversibility of airflow obstruction, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
- AHR in the methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) ≤ 16 mg/mL (Crapo, 2000);
- Have dual response of EAR, defined as a decrease in FEV1 ≥ 20% at 0 to 3 hours after inhalation, and LAR, defined as a decrease in FEV1 ≥ 15% 3 to 7 hours after inhalation, to inhaled allergen;
Key exclusion criteria (23 listed)
- Receipt of MEDI-528 in any previous clinical study;
- History of allergy or adverse reactions to any component of the MEDI-528 formulation;
- Lung disease other than allergic asthma (e.g. chronic bronchitis);
- Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting β2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting β2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0.
- Current use of any β-adrenergic antagonist (e.g. propranolol).
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 |
|---|---|---|
| MEDI-528 9 mg/kgMEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion | Biological | MEDI528 9 mg/kg |
| PlaceboPlacebo administered as a single intravenous infusion | Other | PLACEBO |
Primary outcome
Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7
Time frame: Day 7
Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Time frame: Day 28
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Time frame: Day 56
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7
Time frame: Day 7
Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Time frame: Day 28
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Time frame: Day 56
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
23 secondary outcomes
Incidence of Adverse Events
Time frame: Days 0 - 126
Incidence of Serious Adverse Events
Time frame: Days 0 - 126
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Time frame: Days 0, 27, 55, 84, and 126
Time to Observed Maximum Serum Concentration (Tmax)
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Time to Observed Maximum Sputum Concentration (Tmax)
Time frame: Days -21 to -7, 7, 28, and 56
Time to Observed Maximum Nasal Lavage Concentration (Tmax)
Time frame: Days -6 to -1, 8, 29, and 57
Observed Maximum Serum Concentration (Cmax)
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Observed Maximum Sputum Concentration (Cmax)
Time frame: Days -21 to -7, 7, 28, and 56
Observed Maximum Nasal Lavage Concentration (Cmax)
Time frame: Days -6 to -1, 8, 29, and 57
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Time frame: Days -21 to -7, 7, 28, and 56
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Time frame: Days -6 to -1, 8, 29, and 57
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Time frame: Days -21 to -7, 7, 28, and 56
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Time frame: Days -6 to -1, 8, 29, and 57
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
Time frame: Days -21 to -7, 7, 28, and 56
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
Time frame: Days -6 to -1, 8, 29, and 57
Terminal Phase Half-Life (T1/2)
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Terminal Phase Half-Life (T1/2)
Time frame: Days -21 to -7, 7, 28, and 56
Terminal Phase Half-Life (T1/2)
Time frame: Days -6 to -1, 8, 29, and 57
Total Body Clearance (CL)
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Terminal Phase Volume of Distribution (Vz)
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- 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.
Nestor Molfino, M.D. study director
MedImmune LLC
3 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 MEDI-528 9 mg/kg in people with Asthma, run by MedImmune LLC at 3 sites in Canada.
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 11 inclusion and 23 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 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2013). 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?
Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7 (time frame: Day 7). The study lists 6 primary outcomes in all. 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 Dec 2013.