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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444430
• Other study ID #: D5896C00027
• Secondary ID: 2011-002790-28
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2011
• Last updated: February 12, 2016
• Start date: December 2011
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología MédicaBrazil: Ministry of HealthBrazil: National Health Surveillance AgencyBulgaria: Ministry of HealthChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFrance: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesIndia: Drugs Controller General of IndiaItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: Federal Commission for Protection Against Health RisksPanama: Ministry of HealthPeru: Ministry of HealthPhilippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPuerto Rico: Food and Drug AdministrationRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Sweden: Medical Products AgencyThailand: Food and Drug AdministrationTurkey: Ministry of HealthUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationVietnam: Ho Chi Minh City Health Service, Ministry of Health
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12463
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 130 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort pMDI
80/4.5 µg x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment
• Symbicort pMDI
160/4.5 µg x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment
• budesonide pMDI
80 µg x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment
• budesonide pMDI
160 µg x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment

Locations

Country	Name	City	State
Argentina	Research Site	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
Brazil	Research Site	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
Bulgaria	Research Site	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
Chile	Research Site	Quillota
Chile	Research Site	Santiago
Chile	Research Site	Vina del Mar
Colombia	Research Site	Bogotá
Colombia	Research Site	Cali
Colombia	Research Site	Manizales
Czech Republic	Research Site	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
France	Research Site	Angers
France	Research Site	Perpignan
France	Research Site	Tierce
Germany	Research Site	Berlin
Germany	Research Site	Hamburg
Germany	Research Site	Leipzig
Germany	Research Site	Marburg
India	Research Site	Bangalore
India	Research Site	Calicut
India	Research Site	Coimbatore
India	Research Site	Goa
India	Research Site	Hyderabad
India	Research Site	Mangalore
India	Research Site	Mysore
India	Research Site	Nagpur
India	Research Site	New Delhi
India	Research Site	Trivandrum
Italy	Research Site	Benevento
Italy	Research Site	Bologna
Italy	Research Site	Catanzaro
Italy	Research Site	Ferrara
Italy	Research Site	Genova
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Palermo
Italy	Research Site	Roma
Korea, Republic of	Research Site	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
Mexico	Research Site	Durango
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico
Mexico	Research Site	México
Mexico	Research Site	Monterey
Mexico	Research Site	Monterrey
Mexico	Research Site	Morelia
Mexico	Research Site	Santiago de Querétaro
Mexico	Research Site	Villahermosa
Mexico	Research Site	Zapopan
Panama	Research Site	Ciudad de Panama
Peru	Research Site	Cusco
Peru	Research Site	Lima
Philippines	Research Site	Iloilo City
Philippines	Research Site	Lipa City
Philippines	Research Site	Manila
Philippines	Research Site	Pasig City
Philippines	Research Site	Quezon City
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Checiny
Poland	Research Site	Gorzów Wlkp
Poland	Research Site	Karpacz
Poland	Research Site	Kraków
Poland	Research Site	Ostrów Wielkopolski
Poland	Research Site	Skarzysko 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	Wroclaw
Puerto Rico	Research Site	Caguas
Puerto Rico	Research Site	San Juan
Puerto Rico	Research Site	Toa Baja
Romania	Research Site	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
Russian Federation	Research Site	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
Slovakia	Research Site	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
South Africa	Research Site	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
Thailand	Research Site	Bangkok
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Muang,
Thailand	Research Site	Naimuang
Ukraine	Research Site	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
United Kingdom	Research Site	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 States	Research Site	Abington	Pennsylvania
United States	Research Site	Alhambra	California
United States	Research Site	Altamonte Springs	Florida
United States	Research Site	Ames	Iowa
United States	Research Site	Anaheim	California
United States	Research Site	Anchorage	Alaska
United States	Research Site	Anderson	Indiana
United States	Research Site	Arvin	California
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baytown	Texas
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Bellflower	California
United States	Research Site	Bend	Oregon
United States	Research Site	Biloxi	Mississippi
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bridgeton	Missouri
United States	Research Site	Bronx	New York
United States	Research Site	Bryn Mawr	Pennsylvania
United States	Research Site	Buena Park	California
United States	Research Site	Calhoun	Georgia
United States	Research Site	Cary	North Carolina
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Conyers	Georgia
United States	Research Site	Costa Mesa	California
United States	Research Site	Council Bluffs	Iowa
United States	Research Site	Cutler Bay	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Danville	Virginia
United States	Research Site	Decatur	Georgia
United States	Research Site	DeLand	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Doylestown	Pennsylvania
United States	Research Site	Duluth	Minnesota
United States	Research Site	Edina	Minnesota
United States	Research Site	Encinitas	California
United States	Research Site	Escondido	California
United States	Research Site	Evansville	Indiana
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fort Lauderdale	Florida
United States	Research Site	Fort Mitchell	Kentucky
United States	Research Site	Fort Myers	Florida
United States	Research Site	Fort Smith	Arkansas
United States	Research Site	Fort Worth	Texas
United States	Research Site	Fountain Valley	California
United States	Research Site	Gainesville	Florida
United States	Research Site	Gainesville	Georgia
United States	Research Site	Georgetown	Texas
United States	Research Site	Gilbert	Arizona
United States	Research Site	Glendale	Arizona
United States	Research Site	Glendale	California
United States	Research Site	Grand Island	Nebraska
United States	Research Site	Great Neck	New York
United States	Research Site	Greeneville	South Carolina
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Greenville	South Carolina
United States	Research Site	Greer	South Carolina
United States	Research Site	Hayden Lake	Idaho
United States	Research Site	Hialeah	Florida
United States	Research Site	Hopewell Jct	New York
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indian Land	South Carolina
United States	Research Site	Jackson	Mississippi
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kenilworth	Illinois
United States	Research Site	Killeen	Texas
United States	Research Site	Kissimmee	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	La Crosse	Wisconsin
United States	Research Site	Lafayette	Louisiana
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Lanham	Maryland
United States	Research Site	Layton	Utah
United States	Research Site	Leesburg	Florida
United States	Research Site	Lehigh Acres	Florida
United States	Research Site	Lexington	Kentucky
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Lynn Haven	Florida
United States	Research Site	Madison Hgts	Michigan
United States	Research Site	McKinney	Texas
United States	Research Site	Meridan	Idaho
United States	Research Site	Mesa	Arizona
United States	Research Site	Miami	Florida
United States	Research Site	Miami Beach	Florida
United States	Research Site	Miamishburg	Ohio
United States	Research Site	Michigan City	Indiana
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
United States	Research Site	Northridge	California
United States	Research Site	Norwalk	Connecticut
United States	Research Site	Ocoee	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Opalocka	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Owensboro	Kentucky
United States	Research Site	Palmdale	California
United States	Research Site	Pasadena	California
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Pharr	Texas
United States	Research Site	Phoenixville	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plano	Texas
United States	Research Site	Port Huron	Michigan
United States	Research Site	Poway	California
United States	Research Site	Riverside	California
United States	Research Site	Rochester	New York
United States	Research Site	Rockville Centre	New York
United States	Research Site	Roseville	California
United States	Research Site	Royal Palm Beach	Florida
United States	Research Site	Salisbury	North Carolina
United States	Research Site	San Antonio	Texas
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	Savannah	Georgia
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	South Burlington	Vermont
United States	Research Site	Southfield	Michigan
United States	Research Site	Spokane	Washington
United States	Research Site	Spring	Texas
United States	Research Site	Springfield	Missouri
United States	Research Site	Springfield	Illinois
United States	Research Site	St Louis	Missouri
United States	Research Site	Sterling Heights	Michigan
United States	Research Site	Stockton	California
United States	Research Site	Stow	Ohio
United States	Research Site	Sugar Land	Texas
United States	Research Site	Sugarland	Texas
United States	Research Site	Summerville	South Carolina
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Thornton	Colorado
United States	Research Site	Tucson	Arizona
United States	Research Site	Tustin	California
United States	Research Site	Verona	New Jersey
United States	Research Site	Vicksburg	Mississippi
United States	Research Site	Vienna	Virginia
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Waco	Texas
United States	Research Site	Walnut Creek	California
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Watertown	Massachusetts
United States	Research Site	Watertown	New York
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Wyomissing	Pennsylvania
United States	Research Site	Ypsilanti	Michigan
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Brazil,  Bulgaria,  Chile,  Colombia,  Czech Republic,  France,  Germany,  India,  Italy,  Korea, Republic of,  Mexico,  Panama,  Peru,  Philippines,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first event in composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization)		Up to 27 weeks	Yes
Primary	Time to first event included in the definition of asthma exacerbation	Asthma exacerbations, 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	Up to 26 weeks	No
Secondary	Percent of days with no asthma symptoms		daily up to 26 weeks	No
Secondary	Percent of days with no activity limitation due to asthma		daily up to 26 weeks	No
Secondary	Mean number of puffs of rescue medication per day		daily up to 26 weeks	No
Secondary	Asthma Control Questionnaire (ACQ6)		baseline, day 28, day 84, day 182	No