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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01444430
First received: September 23, 2011
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Symbicort pMDI
Drug: budesonide pMDI
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to first event in composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization) [ Time Frame: Up to 27 weeks ] [ Designated as safety issue: Yes ]
  • Time to first event included in the definition of asthma exacerbation [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Percent of days with no asthma symptoms [ Time Frame: daily up to 26 weeks ] [ Designated as safety issue: No ]
  • Percent of days with no activity limitation due to asthma [ Time Frame: daily up to 26 weeks ] [ Designated as safety issue: No ]
  • Mean number of puffs of rescue medication per day [ Time Frame: daily up to 26 weeks ] [ Designated as safety issue: No ]
  • Asthma Control Questionnaire (ACQ6) [ Time Frame: baseline, day 28, day 84, day 182 ] [ Designated as safety issue: No ]

Estimated Enrollment: 11700
Study Start Date: December 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Symbicort 80
Drug: Symbicort pMDI
80/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment
Experimental: 2
Symbicort 160
Drug: Symbicort pMDI
160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment
Active Comparator: 3
budesonide 80
Drug: budesonide pMDI
80 μg x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment
Active Comparator: 4
budesonide 160
Drug: budesonide pMDI
160 μg x 2 actuations bid (morning and evening), for oral inhalation, 26-week 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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444430

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com

  Show 486 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carin Jorup AstraZeneca Pepparedsleden 1, 431 83 Mölndal
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01444430     History of Changes
Other Study ID Numbers: D5896C00027, 2011-002790-28
Study First Received: September 23, 2011
Last Updated: October 24, 2014
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología MédicaBrazil: Ministry of Health
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Panama: Ministry of Health
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Puerto Rico: Food and Drug Administration
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Thailand: Food and Drug Administration
Turkey: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Vietnam: Ho Chi Minh City Health Service, Ministry of Health

Keywords provided by AstraZeneca:
Symbicort pMDI
Asthma
safety
budesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Symbicort
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014