Comparison of ICS in combination with LABA versus ICS alone

• Research type

  Research Study

• Full 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 ß2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (=12 years of age) patients with asthma

• IRAS ID

  116507

• Contact name

  Bhavesh Bodalia

• Sponsor organisation

  AstraZeneca

• Eudract number

  2011-002790-28

• Clinicaltrials.gov Identifier

  NCT01444430

• Research summary

  This clinical study will test whether patients taking Symbicort© pMDI (kind of pressurized metered dose inhaler in which two drugs are combined, namely budesonide and formoterol) have a higher risk of having uncommon but serious problems when compared to patients taking budesonide alone. Large clinical studies are required to study these problems because they are so rare and cannot be determined from smaller size studies. Other aspects that will be examined during this study are for example if the asthma has gotten worse during any period of the study, if patient utilized any health care systems due to asthma or if patient has missed work or school due to asthma.This study is being done to help answer an important safety question about formoterol (one of the drugs in Symbicort) and to add information about its benefit when used in combination with budesonide in the treatment of asthma.Approximately 11 700 patients in about 25 different countries will take part in this study. In addition to this study, other companies with similar products (containing long acting bronchodilators) will run similar studies with their products. Each study will consist of approximately 11 700 asthmatic patients aged 12 years and older.This study will last about 27 weeks. During this time patients will need to visit the clinic on schedule, and tell the Study Doctor about any changes in the asthma condition. The study involves 5 planned visits to the study site and 4 monthly telephone contacts with the site.At any time during the course of the study patients are free to withdraw from study assessments and/or study treatment. When patients have finished taking part in this study, Study Doctor will decide how to continue to manage asthma, and place patients on an appropriate asthma therapy.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  12/EM/0472

• Date of REC Opinion

  8 Feb 2013

• REC opinion

  Further Information Favourable Opinion