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

November 29, 2016 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Mar del Plata, Argentina
        • Research Site
      • Monte Grande, Argentina
        • Research Site
      • Quilmes, Argentina
        • Research Site
      • Ranelagh, Argentina
        • Research Site
      • San Miguel de Tucuman, Argentina
        • Research Site
      • San Miguel de Tucumán, Argentina
        • Research Site
  • Brazil
      • Barueri, Brazil
        • Research Site
      • Botucatu, Brazil
        • Research Site
      • Goiania, Brazil
        • Research Site
      • Juiz de Fora, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Santo André, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Bulgaria
      • Gotse Delchev, Bulgaria
        • Research Site
      • Kozloduy, Bulgaria
        • Research Site
      • Petrich, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Razgrad, Bulgaria
        • Research Site
      • Razlog, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Sandanski, Bulgaria
        • Research Site
      • Sevlievo, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
      • Vidin, Bulgaria
        • Research Site
  • Chile
      • Quillota, Chile
        • Research Site
      • Santiago, Chile
        • Research Site
      • Vina del Mar, Chile
        • Research Site
  • Colombia
      • Bogotá, Colombia
        • Research Site
      • Cali, Colombia
        • Research Site
      • Manizales, Colombia
        • Research Site
  • Czech Republic
      • Beroun, Czech Republic
        • Research Site
      • Breclav, Czech Republic
        • Research Site
      • Krnov, Czech Republic
        • Research Site
      • Kutna Hora, Czech Republic
        • Research Site
      • Litomerice, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
      • Praha 10, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
      • Praha 8, Czech Republic
        • Research Site
      • Rokycany, Czech Republic
        • Research Site
  • France
      • Angers, France
        • Research Site
      • Perpignan, France
        • Research Site
      • Tierce, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Calicut, India
        • Research Site
      • Coimbatore, India
        • Research Site
      • Goa, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Mangalore, India
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      • Mysore, India
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      • Nagpur, India
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      • New Delhi, India
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      • Trivandrum, India
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  • Italy
      • Benevento, Italy
        • Research Site
      • Bologna, Italy
        • Research Site
      • Catanzaro, Italy
        • Research Site
      • Ferrara, Italy
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      • Genova, Italy
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      • Napoli, Italy
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      • Padova, Italy
        • Research Site
      • Palermo, Italy
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      • Roma, Italy
        • Research Site
  • Korea, Republic of
      • Ansan-si, Korea, Republic of
        • Research Site
      • Cheonan-si, Korea, Republic of
        • Research Site
      • Cheongju-si, Korea, Republic of
        • Research Site
      • Jinju-si, Korea, Republic of
        • Research Site
      • Seongnam-si, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
  • Mexico
      • Durango, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Mexico, Mexico
        • Research Site
      • Monterey, Mexico
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      • Monterrey, Mexico
        • Research Site
      • Morelia, Mexico
        • Research Site
      • México, Mexico
        • Research Site
      • Santiago de Querétaro, Mexico
        • Research Site
      • Villahermosa, Mexico
        • Research Site
      • Zapopan, Mexico
        • Research Site
  • Panama
      • Ciudad de Panama, Panama
        • Research Site
  • Peru
      • Cusco, Peru
        • Research Site
      • Lima, Peru
        • Research Site
  • Philippines
      • Iloilo City, Philippines
        • Research Site
      • Lipa City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Pasig City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Białystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Chęciny, Poland
        • Research Site
      • Gorzów Wlkp, Poland
        • Research Site
      • Karpacz, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Ostrów Wielkopolski, Poland
        • Research Site
      • Skarżysko Kamienna, Poland
        • Research Site
      • Strzelce Opolskie, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Tarnów, Poland
        • Research Site
      • Turek, Poland
        • Research Site
      • Urszulin, Poland
        • Research Site
      • Wrocław, Poland
        • Research Site
  • Puerto Rico
      • Caguas, Puerto Rico
        • Research Site
      • San Juan, Puerto Rico
        • Research Site
      • Toa Baja, Puerto Rico
        • Research Site
  • Romania
      • Bragadiru, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj Napoca, Romania
        • Research Site
      • Constanta, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Deva, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Tg. Mures, Romania
        • Research Site
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Research Site
      • Kazan, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Penza, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Saint-Petersburg, Russian Federation
        • Research Site
      • Saratov, Russian Federation
        • Research Site
      • St-Petersburg, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • StPetersburg, Russian Federation
        • Research Site
      • Vladikavkaz, Russian Federation
        • Research Site
      • Volgograd, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
      • Yekaterinburg, Russian Federation
        • Research Site
  • Slovakia
      • Bardejov, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Dunajska Streda, Slovakia
        • Research Site
      • Komarno, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Liptovsky Mikulas, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
      • Skalica, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
      • Zvolen, Slovakia
        • Research Site
  • South Africa
      • Boksburg North, South Africa
        • Research Site
      • Breyton, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Lenasia, South Africa
        • Research Site
      • Lyttleton, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
      • Umkomaas, South Africa
        • Research Site
      • Verulam, South Africa
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Hat Yai, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
      • Muang,, Thailand
        • Research Site
      • Naimuang, Thailand
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Odesa, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
      • Vinnitsa, Ukraine
        • Research Site
      • Zaporozye, Ukraine
        • Research Site
  • United Kingdom
      • Bath, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Blackpool, United Kingdom
        • Research Site
      • Canterbury, United Kingdom
        • Research Site
      • Chippenham, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Crawley, United Kingdom
        • Research Site
      • Leamington Spa, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Stockport, United Kingdom
        • Research Site
      • Trowbridge, United Kingdom
        • Research Site
      • Watford, United Kingdom
        • Research Site
      • Westbury, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
      • Huntsville, Alabama, United States
        • Research Site
    • Alaska
      • Anchorage, Alaska, United States
        • Research Site
    • Arizona
      • Gilbert, Arizona, United States
        • Research Site
      • Glendale, Arizona, United States
        • Research Site
      • Mesa, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Fort Smith, Arkansas, United States
        • Research Site
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Alhambra, California, United States
        • Research Site
      • Anaheim, California, United States
        • Research Site
      • Arvin, California, United States
        • Research Site
      • Bellflower, California, United States
        • Research Site
      • Buena Park, California, United States
        • Research Site
      • Costa Mesa, California, United States
        • Research Site
      • Encinitas, California, United States
        • Research Site
      • Escondido, California, United States
        • Research Site
      • Fountain Valley, California, United States
        • Research Site
      • Glendale, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Newport Beach, California, United States
        • Research Site
      • Northridge, California, United States
        • Research Site
      • Palmdale, California, United States
        • Research Site
      • Pasadena, California, United States
        • Research Site
      • Poway, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • Roseville, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Jose, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
      • Stockton, California, United States
        • Research Site
      • Tustin, California, United States
        • Research Site
      • Walnut Creek, California, United States
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    • Colorado
      • Denver, Colorado, United States
        • Research Site
      • Thornton, Colorado, United States
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, United States
        • Research Site
      • Waterbury, Connecticut, United States
        • Research Site
    • Florida
      • Altamonte Springs, Florida, United States
        • Research Site
      • Clearwater, Florida, United States
        • Research Site
      • DeLand, Florida, United States
        • Research Site
      • Fort Lauderdale, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Gainesville, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Kissimmee, Florida, United States
        • Research Site
      • Leesburg, Florida, United States
        • Research Site
      • Lehigh Acres, Florida, United States
        • Research Site
      • Lynn Haven, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Miami Beach, Florida, United States
        • Research Site
      • Ocoee, Florida, United States
        • Research Site
      • Opalocka, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Pembroke Pines, Florida, United States
        • Research Site
      • Royal Palm Beach, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
    • Georgia
      • Calhoun, Georgia, United States
        • Research Site
      • Conyers, Georgia, United States
        • Research Site
      • Decatur, Georgia, United States
        • Research Site
      • Gainesville, Georgia, United States
        • Research Site
      • Savannah, Georgia, United States
        • Research Site
    • Idaho
      • Hayden Lake, Idaho, United States
        • Research Site
      • Meridan, Idaho, United States
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    • Illinois
      • Kenilworth, Illinois, United States
        • Research Site
      • Springfield, Illinois, United States
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    • Indiana
      • Anderson, Indiana, United States
        • Research Site
      • Evansville, Indiana, United States
        • Research Site
      • Michigan City, Indiana, United States
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    • Iowa
      • Ames, Iowa, United States
        • Research Site
      • Council Bluffs, Iowa, United States
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, United States
        • Research Site
      • Lexington, Kentucky, United States
        • Research Site
      • Owensboro, Kentucky, United States
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    • Louisiana
      • Lafayette, Louisiana, United States
        • Research Site
      • Lake Charles, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
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    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Lanham, Maryland, United States
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    • Massachusetts
      • Watertown, Massachusetts, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
      • Madison Hgts, Michigan, United States
        • Research Site
      • Port Huron, Michigan, United States
        • Research Site
      • Southfield, Michigan, United States
        • Research Site
      • Sterling Heights, Michigan, United States
        • Research Site
      • Ypsilanti, Michigan, United States
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States
        • Research Site
      • Edina, Minnesota, United States
        • Research Site
    • Mississippi
      • Biloxi, Mississippi, United States
        • Research Site
      • Jackson, Mississippi, United States
        • Research Site
      • Vicksburg, Mississippi, United States
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    • Missouri
      • Bridgeton, Missouri, United States
        • Research Site
      • Chesterfield, Missouri, United States
        • Research Site
      • Kansas City, Missouri, United States
        • Research Site
      • Springfield, Missouri, United States
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      • St Louis, Missouri, United States
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    • Nebraska
      • Bellevue, Nebraska, United States
        • Research Site
      • Grand Island, Nebraska, United States
        • Research Site
      • Omaha, Nebraska, United States
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    • New Jersey
      • Verona, New Jersey, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
      • Great Neck, New York, United States
        • Research Site
      • Hopewell Jct, New York, United States
        • Research Site
      • New York, New York, United States
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      • Rochester, New York, United States
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      • Rockville Centre, New York, United States
        • Research Site
      • Watertown, New York, United States
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    • North Carolina
      • Cary, North Carolina, United States
        • Research Site
      • Charlotte, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
      • Salisbury, North Carolina, United States
        • Research Site
      • Wilmington, North Carolina, United States
        • Research Site
      • Winston-Salem, North Carolina, United States
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    • North Dakota
      • Fargo, North Dakota, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Miamishburg, Ohio, United States
        • Research Site
      • Stow, Ohio, United States
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    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Bend, Oregon, United States
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Research Site
      • Bryn Mawr, Pennsylvania, United States
        • Research Site
      • Doylestown, Pennsylvania, United States
        • Research Site
      • Phoenixville, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Wyomissing, Pennsylvania, United States
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    • Rhode Island
      • Warwick, Rhode Island, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Greeneville, South Carolina, United States
        • Research Site
      • Greenville, South Carolina, United States
        • Research Site
      • Greer, South Carolina, United States
        • Research Site
      • Indian Land, South Carolina, United States
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      • Summerville, South Carolina, United States
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    • Tennessee
      • Knoxville, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
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    • Texas
      • Austin, Texas, United States
        • Research Site
      • Baytown, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Fort Worth, Texas, United States
        • Research Site
      • Georgetown, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Killeen, Texas, United States
        • Research Site
      • McKinney, Texas, United States
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      • Pharr, Texas, United States
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      • Plano, Texas, United States
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      • San Antonio, Texas, United States
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      • Spring, Texas, United States
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      • Sugar Land, Texas, United States
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      • Sugarland, Texas, United States
        • Research Site
      • Waco, Texas, United States
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    • Utah
      • Layton, Utah, United States
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    • Vermont
      • South Burlington, Vermont, United States
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    • Virginia
      • Danville, Virginia, United States
        • Research Site
      • Vienna, Virginia, United States
        • Research Site
      • Virginia Beach, Virginia, United States
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    • Washington
      • Seattle, Washington, United States
        • Research Site
      • Spokane, Washington, United States
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      • Tacoma, Washington, United States
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    • Wisconsin
      • La Crosse, Wisconsin, United States
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      • Milwaukee, Wisconsin, United States
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  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 130 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
budesonide
Drug: budesonide pMDI
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.
Experimental: 1
Symbicort
Drug: Symbicort pMDI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 27 weeks
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.
Up to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Days With no Asthma Symptoms
Time Frame: Daily up to 26 weeks
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.
Daily up to 26 weeks
Percent of Days With Activity Limitation Due to Asthma
Time Frame: Daily up to 26 weeks
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.
Daily up to 26 weeks
Mean Number of Puffs of Rescue Medication Per 24 Hours
Time Frame: Daily up to 26 weeks
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.
Daily up to 26 weeks
Asthma Control Questionnaire (ACQ6)
Time Frame: baseline, day 28, day 84, day 182

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.
baseline, day 28, day 84, day 182
Percent of Nights With Awakening(s) Due to Asthma
Time Frame: Daily up to 26 weeks
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.
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
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.
Up to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Carin Jorup, AstraZeneca Pepparedsleden 1, 431 83 Mölndal

Publications and helpful links

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General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5896C00027
  • 2011-002790-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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