A 6 month safety study comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents

Study identifier:D5896C00027

ClinicalTrials.gov identifier:NCT01444430

EudraCT identifier:2011-002790-28

CTIS identifier:N/A

Study Complete

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

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Symbicort pMDI, budesonide pMDI

Sex

All

Actual Enrollment

12460

Study type

Interventional

Age

12 Years - 130 Years

Date

Study Start Date: 01 Dec 2011

Primary Completion Date: 01 Oct 2015

Study Completion Date: 01 Oct 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2016 by AstraZeneca

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
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.
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.

Documents available

D5896C00027_Protocol_redacted.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Carin Jorup

AstraZeneca Pepparedsleden 1, 431 83 Mölndal