AsthmaPhase 3NCT01444430

A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

A Phase 3 study testing Symbicort pMDI and budesonide pMDI in people with Asthma, run by AstraZeneca at 340 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma Read more about this study

Who is it for?: Ages 12 to 130 years
Conditions the study is for: Asthma
What is being tested?: Symbicort pMDI and budesonide pMDI
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12,460 participants
Where: 340 sitesin 26 countries
Study dates: Dec 2011to Oct 2015
Phase: Phase 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 12 to 130 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
Male or Female, ≥12 years of age
Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
Patient must have history of at least 1 asthma exacerbation including one of the following:
requiring treatment with systemic corticosteroids
an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Who cannot join

Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
Patient must not meet unstable asthma severity criteria as listed in the protocol
Peak expiratory flow must not be below 50% o predicted normal
Pregnancy, breast-feeding or planned pregnancy during the study

Trial locations and contacts

340 sites in 26 countries.

Country

City, postcode or hospital

340 sites in 26 countries

United States160 sites

Research Site
Abington, Pennsylvania
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Alhambra, California
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Altamonte Springs, Florida
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Ames, Iowa
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Anaheim, California
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Anchorage, Alaska
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Anderson, Indiana
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Arvin, California
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Austin, Texas
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Baltimore, Maryland
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Baytown, Texas
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Bellevue, Nebraska
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Bellflower, California
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Bend, Oregon
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Biloxi, Mississippi
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Birmingham, Alabama
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Bridgeton, Missouri
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Bryn Mawr, Pennsylvania
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Buena Park, California
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Calhoun, Georgia
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Cary, North Carolina
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Charleston, South Carolina
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Charlotte, North Carolina
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Chesterfield, Missouri
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Cincinnati, Ohio
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Clearwater, Florida
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Conyers, Georgia
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Costa Mesa, California
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Council Bluffs, Iowa
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Dallas, Texas
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Danville, Virginia
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Decatur, Georgia
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DeLand, Florida
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Denver, Colorado
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Doylestown, Pennsylvania
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Duluth, Minnesota
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Edina, Minnesota
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Encinitas, California
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Escondido, California
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Evansville, Indiana
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Fargo, North Dakota
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Fort Lauderdale, Florida
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Fort Mitchell, Kentucky
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Fort Myers, Florida
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Fort Smith, Arkansas
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Fort Worth, Texas
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Fountain Valley, California
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Gainesville, Florida
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Gainesville, Georgia
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Georgetown, Texas
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Gilbert, Arizona
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Glendale, Arizona
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Glendale, California
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Grand Island, Nebraska
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Great Neck, New York
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Greeneville, South Carolina
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Greensboro, North Carolina
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Greenville, South Carolina
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Greer, South Carolina
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Hayden Lake, Idaho
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Hialeah, Florida
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Hopewell Jct, New York
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Houston, Texas
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Huntsville, Alabama
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Jackson, Mississippi
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Jacksonville, Florida
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Kalamazoo, Michigan
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Kansas City, Missouri
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Kenilworth, Illinois
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Killeen, Texas
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Kissimmee, Florida
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Knoxville, Tennessee
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La Crosse, Wisconsin
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Lafayette, Louisiana
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Lake Charles, Louisiana
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Lanham, Maryland
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Layton, Utah
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Leesburg, Florida
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Lehigh Acres, Florida
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Lexington, Kentucky
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Little Rock, Arkansas
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Long Beach, California
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Los Angeles, California
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Lynn Haven, Florida
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Madison Hgts, Michigan
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McKinney, Texas
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Meridan, Idaho
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Mesa, Arizona
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Miami, Florida
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Miami Beach, Florida
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Miamishburg, Ohio
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Michigan City, Indiana
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Milwaukee, Wisconsin
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Nashville, Tennessee
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New York, New York
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Newport Beach, California
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Northridge, California
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Norwalk, Connecticut
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Ocoee, Florida
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Oklahoma City, Oklahoma
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Old Point Station, South Carolina
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Omaha, Nebraska
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Opa-locka, Florida
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Orlando, Florida
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Owensboro, Kentucky
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Palmdale, California
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Pasadena, California
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Pembroke Pines, Florida
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Pharr, Texas
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Phoenixville, Pennsylvania
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Pittsburgh, Pennsylvania
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Plano, Texas
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Port Huron, Michigan
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Poway, California
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Riverside, California
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Rochester, New York
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Rockville Centre, New York
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Roseville, California
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Royal Palm Beach, Florida
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Salisbury, North Carolina
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San Antonio, Texas
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San Diego, California
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San Jose, California
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Santa Ana, California
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Savannah, Georgia
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Seattle, Washington
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Shreveport, Louisiana
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South Burlington, Vermont
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Southfield, Michigan
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Spokane, Washington
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Spring, Texas
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Springfield, Illinois
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Springfield, Missouri
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St Louis, Missouri
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Sterling Heights, Michigan
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Stockton, California
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Stow, Ohio
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Sugar Land, Texas
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Sugarland, Texas
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Summerville, South Carolina
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Tacoma, Washington
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Tampa, Florida
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The Bronx, New York
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Thornton, Colorado
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Tucson, Arizona
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Tustin, California
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Verona, New Jersey
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Vicksburg, Mississippi
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Vienna, Virginia
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Virginia Beach, Virginia
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Waco, Texas
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Walnut Creek, California
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Warwick, Rhode Island
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Waterbury, Connecticut
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Watertown, Massachusetts
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Watertown, New York
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Wilmington, North Carolina
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Winston-Salem, North Carolina
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Wyomissing, Pennsylvania
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Ypsilanti, Michigan

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Poland14 sites

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About this study

Official title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

Read the detailed description

A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

Conditions: Asthma
Being tested: Symbicort pMDI, budesonide pMDI
Keywords: Symbicort pMDI, Asthma, safety, budesonide
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Symbicort pMDIDrug
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.
budesonide pMDIDrug
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.

Study groups in NCT01444430
Study group	Role	What they receive
1	Experimental	Symbicort Receives: Drug: Symbicort pMDI
2	Active comparator	budesonide Receives: Drug: budesonide pMDI

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Measured: Up to 27 weeks
Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Measured: Up to 26 weeks

Secondary outcomes (6)

Percent of Days With no Asthma Symptoms
Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Measured: Daily up to 26 weeks
Percent of Days With Activity Limitation Due to Asthma
Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Measured: Daily up to 26 weeks
Mean Number of Puffs of Rescue Medication Per 24 Hours
Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Measured: Daily up to 26 weeks
Asthma Control Questionnaire (ACQ6)
The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide.
The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions.
Measured: baseline, day 28, day 84, day 182
Percent of Nights With Awakening(s) Due to Asthma
Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Measured: Daily up to 26 weeks
Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation
Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Measured: Up to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Oct 2015

First posted30 Sep 2011 (estimated)
Study startDec 2011
Primary completionOct 2015
Study completionOct 2015

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 AstraZenecaThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12,460 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01444430
Sponsor's protocol ID: D5896C00027
Other IDs: 2011-002790-28
Status last verified: Nov 2016
First submitted: 23 Sep 2011
Last updated: 15 Dec 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Peters SP, Bleecker ER, Canonica GW, Park YB, Ramirez R, Hollis S, Fjallbrant H, Jorup C, Martin UJ. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. N Engl J Med. 2016 Sep 1;375(9):850-60. doi: 10.1056/NEJMoa1511190.
PubMed 27579635

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
ClinicalTrials.gov ID: NCT01444430
Acronym / sponsor ID: D5896C00027
Conditions: Asthma
Keywords: Symbicort pMDI, Asthma, safety, budesonide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 12,460 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 30 Sep 2011 (estimated)
Results: Posted 15 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Symbicort pMDISymbicort
2	Active comparator	Drug: budesonide pMDIbudesonide

Who may qualify

Ages: 12 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
Male or Female, ≥12 years of age
Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
Patient must have history of at least 1 asthma exacerbation including one of the following:
Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Key exclusion criteria (8 listed)

Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function

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
Symbicort pMDIPatients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.	Drug	1
budesonide pMDIPatients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.	Drug	2

Primary outcome

Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
Time frame: Up to 27 weeks
Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
Time frame: Up to 26 weeks
Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.

6 secondary outcomes

Percent of Days With no Asthma Symptoms
Time frame: Daily up to 26 weeks
Percent of Days With Activity Limitation Due to Asthma
Time frame: Daily up to 26 weeks
Mean Number of Puffs of Rescue Medication Per 24 Hours
Time frame: Daily up to 26 weeks
Asthma Control Questionnaire (ACQ6)
Time frame: baseline, day 28, day 84, day 182
Percent of Nights With Awakening(s) Due to Asthma
Time frame: Daily up to 26 weeks
Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation
Time frame: Up to 26 weeks

Results and safety

Results posted to the registry on 15 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbicort	5,846	5,785
Budesonide	5,847	5,766

Primary outcome: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)

Time frame: Up to 27 weeks. Number. Unit: Participants

Measure	Symbicort n = 5846	Budesonide n = 5847
Value	43	40

Symbicort vs Budesonide: Hazard Ratio (HR): 1.073 (95% CI 0.698 to 1.650), Regression, Cox

Population analysed: Full analysis set (FAS) population comprised of all patients randomized to study drug.

Primary outcome: Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation

Time frame: Up to 26 weeks. Number. Unit: Participants

Measure	Symbicort n = 5846	Budesonide n = 5847
Value	539	633

Symbicort vs Budesonide: Hazard Ratio (HR): 0.835 (95% CI 0.745 to 0.937), p = 0.002, Regression, Cox

Population analysed: The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient's period of exposure to study drug plus 7 days after the last date of study drug treatment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort	125 of 5,846 (2.1%)	0 of 5,846 (0%)	Not reported
Budesonide	123 of 5,847 (2.1%)	0 of 5,847 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27579635Peters SP, Bleecker ER, Canonica GW, Park YB, Ramirez R, Hollis S, Fjallbrant H, Jorup C, Martin UJ. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. N Engl J Med. 2016 Sep 1;375(9):850-60. doi: 10.1056/NEJMoa1511190.
D5896C00027\_Protocol\_redacted.pdfLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carin Jorup study director

AstraZeneca Pepparedsleden 1, 431 83 Mölndal

340 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Symbicort pMDI and budesonide pMDI in people with Asthma, run by AstraZeneca at 340 sites in 26 countries.

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 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 340 sites in United States, Poland, Bulgaria, United Kingdom, Slovakia and 21 more countries. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2016). 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?

Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (time frame: Up to 27 weeks). The study lists 2 primary outcomes in all. 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 NCT01444430, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.