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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02224157
• Date of registration: 19/08/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma SYGMA2
• Scientific title: A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
• Date of first enrolment: November 28, 2014
• Target sample size: 4215
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02224157
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Brazil, Bulgaria, Chile, Colombia, Czech Republic, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, New Zealand, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Thailand, Ukraine, Vietnam

Contacts

• Name: Carin Jorup, MD
• Affiliation: AstraZeneca Research & Development

Key inclusion & exclusion criteria

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



Age minimum: 12 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

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

Drug: budesonode bid + terbutaline 'as needed'

Primary Outcome(s)

Annual Severe Asthma Exacerbation Rate - Superiority Analysis [Time Frame: up to 52 weeks]

Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis [Time Frame: up to 52 weeks]

Secondary Outcome(s)

Change From Baseline in Percent of 'as Needed' Free Days [Time Frame: Week 0 up to 52 weeks]

Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score [Time Frame: Study weeks 0, 17, 34, 52]

Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score [Time Frame: Study weeks 0,17, 34, 52]

Average Change From Baseline in 'as Needed' Use [Time Frame: Week 0 up to 52 weeks]

Number of Participants Experiencing at Least One Severe Asthma Exacerbation [Time Frame: Day 1 up to 52 weeks]

Average Change From Baseline in Pre-bronchodilator FEV1 [Time Frame: Study weeks 0,17, 34, 52]

Number of Participants With Study Specific Asthma Related Discontinuation [Time Frame: Day 1 up to 52 weeks]

Percentage of Controller Use Days [Time Frame: Week 0 up to 52 weeks]

Secondary ID(s)

D589SC00003

2013-004473-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02224157