A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma (SYGMA2)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: budesonide/formoterol 'as needed' + budesonide placebo bid; Drug: budesonode bid + terbutaline 'as needed'

Study type: Interventional

Funder types: Industry

Identifiers

NCT02224157

2013-004473-28 (EudraCT Number)

D589SC00003

Details and patient eligibility

About

The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

Full description

A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'

Enrollment: 4,215 patients

Sex: All

Ages: 12 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
2. Male or Female, ≥12 years of age
3. Documented diagnosis of asthma for at least 6 months prior to Visit 1
4. Patients who are in need of GINA step 2 treatment
5. Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
7. Patients should have reversible airway obstruction
8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period

Exclusion criteria

1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission
2. Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
4. Current or previous smoker with a smoking history of ≥ 10 pack years
5. Pregnancy, breast-feeding or planned pregnancy during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

4,215 participants in 2 patient groups

Symbicort "as needed"+placebo Pulmicort bid

Experimental group

Description:

Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid

Treatment:

Drug: budesonide/formoterol 'as needed' + budesonide placebo bid

Pulmicort bid + terbutaline "as needed"

Active Comparator group

Description:

Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'

Treatment:

Drug: budesonode bid + terbutaline 'as needed'