AsthmaPhase 2NCT01312961
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
A Phase 2 study testing Dupilumab, Fluticasone/Salmeterol combination therapy and Fluticasone monotherapy in people with Asthma, run by Sanofi at 50 sites in United States.
Trial summary
Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic 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?
- Dupilumab, Fluticasone/Salmeterol combination therapy and Fluticasone monotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 50 sitesUnited States
- Study dates
- Mar 2011to Oct 2012
- 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
- Medical diagnosis of persistent asthma for at least 12 months whose:
- airway inflammation likely to be eosinophilic,
- asthma partially controlled or uncontrolled on ICS plus LABA therapy.
- On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol, Mometasone/Formoterol combination therapy for at least 1 month prior to screening.
- Signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.
Who cannot join
- Less than 18 years or greater than 65 years of age.
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
- Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests.
- Beta-adrenergic receptor blockers required for any reason.
- Current smoker or cessation of smoking within the 6 months prior to screening.
- Previous smoking with a smoking history >10 cigarette pack/years.
Show all 14Show fewer
- Participation in another study within 6 months prior to screening if the study medication was an antibody or within 30 days prior to screening for all other study medications.
- Known or suspected non-compliance, alcohol or drug abuse.
- Inability to follow the procedures of the study (e.g, due to language problems, psychological disorders).
- Concomitant severe diseases or diseases for which the use of ICS or LABA were contraindicated.
- Known allergy to doxycycline or related compounds.
- Pregnancy or intention to become pregnant during the course of the study, breast feeding, or unwillingness to use a highly effective method of contraception throughout the study in women of childbearing potential.
- Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Investigational Site Number 840047
Anaheim, California, 92804
Investigational Site Number 840014
Baltimore, Maryland, 21287
Investigational Site Number 840022
Bozeman, Montana, 59718
Investigational Site Number 840027
Charleston, South Carolina, 29407
Investigational Site Number 840031
Colorado Springs, Colorado, 80907
Investigational Site Number 840011
Denver, Colorado, 80206
Investigational Site Number 840017
Denver, Colorado, 80230
Investigational Site Number 840030
El Paso, Texas, 79902
Investigational Site Number 840040
Hershey, Pennsylvania, 17033
Investigational Site Number 840028
Indianapolis, Indiana, 46208
Investigational Site Number 840038
Iowa City, Iowa, 52240
Investigational Site Number 840001
Lake Oswego, Oregon, 97035
Investigational Site Number 840046
Long Beach, California, 90806
Investigational Site Number 840032
Los Angeles, California, 90025
Investigational Site Number 840036
Los Angeles, California, 90048
Investigational Site Number 840034
Madison, Wisconsin, 53792
Investigational Site Number 840012
Medford, Oregon, 97504
Investigational Site Number 840003
Minneapolis, Minnesota, 55402
Investigational Site Number 840010
Minneapolis, Minnesota, 55402
Investigational Site Number 840005
Mission Viejo, California, 92691
Investigational Site Number 840026
New Haven, Connecticut, 06510
Investigational Site Number 840015
North Dartmouth, Massachusetts, 02747
Investigational Site Number 840045
Oklahoma City, Oklahoma, 73120
Investigational Site Number 840025
Omaha, Nebraska, 68131
Investigational Site Number 840007
Orange, California, 92868
Investigational Site Number 840021
Overland Park, Kansas, 66210
Investigational Site Number 840053
Owensboro, Kentucky, 42303
Investigational Site Number 840008
Papillion, Nebraska, 27103
Investigational Site Number 840037
Pittsburgh, Pennsylvania, 15213
Investigational Site Number 840016
Portland, Oregon, 97209
Investigational Site Number 840018
Princeton, New Jersey, 08540
Investigational Site Number 840049
Richmond, Virginia, 23229
Investigational Site Number 840048
Riverside, California, 92506
Investigational Site Number 840035
Rolling Hills Estates, California, 90274
Investigational Site Number 840050
San Antonio, Texas, 78229
Investigational Site Number 840041
San Francisco, California, 94143
Investigational Site Number 840042
San Francisco, California, 94143
Investigational Site Number 840039
San Jose, California, 95117
Investigational Site Number 840024
Santa Rosa, California, 95405
Investigational Site Number 840020
Seattle, Washington, 98105
Investigational Site Number 840052
South Burlington, Vermont, 05403
Investigational Site Number 840006
St Louis, Missouri, 63110
Investigational Site Number 840013
St Louis, Missouri, 63141
Investigational Site Number 840002
Stockton, California, 95207
Investigational Site Number 840023
Sylvania, Ohio, 43560
Investigational Site Number 840019
Tacoma, Washington, 98415-0299
Investigational Site Number 840044
Tallahassee, Florida, 32308
Investigational Site Number 840029
Tampa, Florida, 33612
Investigational Site Number 840009
Upland, Pennsylvania, 19013
Investigational Site Number 840004
Winston-Salem, North Carolina, 27157-1071
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy
Primary Objective:
To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma.
Secondary Objectives:
- To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
- To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
Read the detailed description
The total duration of the study period per participant was 20-22 weeks broken down as follows:
- Screening period: up to 14 days,
- Treatment period: 12 weeks,
- Follow-up period: 6-8 weeks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called SAR231893, REGN668
Solution for injection, one subcutaneous injection.
Placebo (for Dupilumab)Drug
Solution for injection, one subcutaneous injection.
Fluticasone/Salmeterol combination therapyDrug
Oral inhalation twice daily.
Fluticasone monotherapyDrug
Oral inhalation twice daily.
AlbuterolDrug
Oral inhalation as needed.
LevalbuterolDrug
Oral inhalation as needed.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (for Dupilumab) | Placebo comparator | Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. Receives: Drug: Placebo (for Dupilumab); Drug: Fluticasone/Salmeterol combination therapy; Drug: Fluticasone monotherapy; Drug: Albuterol; Drug: Levalbuterol |
| Dupilumab 300 mg qw | Experimental | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. Receives: Drug: Dupilumab; Drug: Fluticasone/Salmeterol combination therapy; Drug: Fluticasone monotherapy; Drug: Albuterol; Drug: Levalbuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Asthma Exacerbation
An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.
Measured: Baseline up to Week 12
Secondary outcomes (10)
Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12
The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.
Measured: Baseline up to Week 12
Percentage of Participants With Composite Asthma Events
Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.
Measured: Baseline up to Week 12
Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Baseline, Week 12
Change From Baseline in Peak Expiratory Flow (PEF) to Week 12
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Measured: Baseline, Week 12
Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12
ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.
Measured: Baseline, Week 12
Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12
The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Measured: Baseline, Week 12
Change From Baseline in Morning Asthma Symptom Scores to Week 12
AM (ante meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Measured: Baseline, Week 12
Change From Baseline in Evening Asthma Symptom Scores to Week 12
PM (post meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Measured: Baseline, Week 12
Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12
Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Measured: Baseline, Week 12
Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12
Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312961
- Sponsor's protocol ID
- ACT11457
- Other IDs
- U1111-1117-7826
- Status last verified
- Jun 2017
- First submitted
- 9 Mar 2011
- Last updated
- 8 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.
PubMed 23688323
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy
- ClinicalTrials.gov ID
- NCT01312961
- Acronym / sponsor ID
- ACT11457
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 8 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma.
Secondary Objectives:
- To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
- To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
Detailed description
The total duration of the study period per participant was 20-22 weeks broken down as follows:
- Screening period: up to 14 days,
- Treatment period: 12 weeks,
- Follow-up period: 6-8 weeks.
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 |
|---|---|---|
| Placebo (for Dupilumab) | Placebo comparator | Drug: Placebo (for Dupilumab), Drug: Fluticasone/Salmeterol combination therapy, Drug: Fluticasone monotherapy, Drug: Albuterol, Drug: LevalbuterolPlacebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
| Dupilumab 300 mg qw | Experimental | Drug: Dupilumab, Drug: Fluticasone/Salmeterol combination therapy, Drug: Fluticasone monotherapy, Drug: Albuterol, Drug: LevalbuterolDupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- airway inflammation likely to be eosinophilic,
- asthma partially controlled or uncontrolled on ICS plus LABA therapy.
- On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol, Mometasone/Formoterol combination therapy for at least 1 month prior to screening.
- Signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.
Key exclusion criteria (14 listed)
- Less than 18 years or greater than 65 years of age.
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
- Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests.
- Beta-adrenergic receptor blockers required for any reason.
- Current smoker or cessation of smoking within the 6 months prior to screening.
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 |
|---|---|---|
| DupilumabAlso: SAR231893, REGN668Solution for injection, one subcutaneous injection. | Drug | Dupilumab 300 mg qw |
| Placebo (for Dupilumab)Solution for injection, one subcutaneous injection. | Drug | Placebo (for Dupilumab) |
| Fluticasone/Salmeterol combination therapyOral inhalation twice daily. | Drug | Dupilumab 300 mg qw, Placebo (for Dupilumab) |
| Fluticasone monotherapyOral inhalation twice daily. | Drug | Dupilumab 300 mg qw, Placebo (for Dupilumab) |
| AlbuterolOral inhalation as needed. | Drug | Dupilumab 300 mg qw, Placebo (for Dupilumab) |
| LevalbuterolOral inhalation as needed. | Drug | Dupilumab 300 mg qw, Placebo (for Dupilumab) |
Primary outcome
Percentage of Participants With Asthma Exacerbation
Time frame: Baseline up to Week 12
An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.
10 secondary outcomes
Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12
Time frame: Baseline up to Week 12
Percentage of Participants With Composite Asthma Events
Time frame: Baseline up to Week 12
Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12
Time frame: Baseline, Week 12
Change From Baseline in Peak Expiratory Flow (PEF) to Week 12
Time frame: Baseline, Week 12
Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12
Time frame: Baseline, Week 12
Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12
Time frame: Baseline, Week 12
Change From Baseline in Morning Asthma Symptom Scores to Week 12
Time frame: Baseline, Week 12
Change From Baseline in Evening Asthma Symptom Scores to Week 12
Time frame: Baseline, Week 12
Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12
Time frame: Baseline, Week 12
Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23688323Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.
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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.
Clinical Sciences & Operations study director
Sanofi
50 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 Dupilumab, Fluticasone/Salmeterol combination therapy and Fluticasone monotherapy in people with Asthma, run by Sanofi at 50 sites in United States.
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 14 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 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. 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 8 Jun 2017). 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?
Percentage of Participants With Asthma Exacerbation (time frame: Baseline up to Week 12). 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 NCT01312961, 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 8 Jun 2017.