A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort® (budesonide/formoterol) pMDI 40/2.25 µg twice daily compared with 1 inhalation Symbicort Turbuhaler® 80/4.5 µg twice daily and 1 inhalation Pulmicort® (budesonide) Turbuhaler® 100 µg twice daily in adult and adolescent asthmatics - ESTHER

• Conditions: asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2007-002734-11-HU
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

For inclusion in the study, patients must fulfill all of the following criteria at Visit 2:

1. Signed informed consent from the patient. For the under-aged patients, signed informed consent is required from both the patient and the patient's parent/legal guardian.
2. Out-patients of either sex, 12 years and above.
3. Asthma according to the American Thoracic Society (ATS) definition, clinically diagnosed at least 6 months prior to Visit 2.
4. Pre-bronchodilator FEV1 = ?50% and = ?90% of predicted normal.
5. Patients with reversible airway obstruction (from a reversibility test performed at Visit 2), defined as an increase in FEV1 of = 12% relative to baseline (for all patients), and for patients =18 years =200 mL after inhalation of in total 1 mg Bricanyl Turbuhaler..
6. Daily use of inhaled GCS (any brand) for >3 months prior to Visit 2.
7. During 30 days prior to Visit 2, the dose of inhaled GCS should have been constant and within the range of 200-500 µg/day (any brand).
8. Ability to use pMDI, Turbuhaler, and peak flow meter correctly.
9. Able to read and write and use the electronic devices.

For randomization into the study, patients must fulfill all of the following criteria at Visit 3:

1. Run-in diary data for mPEF recorded on at least 7 (any 7) of the last 10 days of the run-in period (including the day of Visit 3).
2. Total asthma symptom score (night-time plus daytime) of >1 on at least 4 (any of the last 7 days of the run-in period (not including the recording in the morning of Visit 3.
3. No change in asthma treatment during the run-in period.
4. Continued eligibility for the study in accordance with the exclusion criteria.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of oral, rectal or parenteral GCS within 30 days prior to Visit 2.
2. Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to Visit 2.
3. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.
4. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
5. Pregnancy, breast-feeding or planned pregnancy during the study. Women and where applicable, girls of child-bearing potential without acceptable contraceptive measures as judged by the investigator.
6. Known or suspected hypersensitivity to budesonide, formoterol, inhaled lactose, PVP K25, PEG 1000, HFA-227.
7. Present use of any ß-blocker (including eye-drops).
8. History of = 10 pack-years of smoking (i.e. equivalent of smoking 20 cigarettes per day for 10 years).
9. Planned donation of blood during the study.
10. Planned hospitalization during the study.
11. Suspected poor capability, as judged by the investigator, to follow instructions of the study, e.g., because of a history of alcohol or drug abuse.
12. Participation in another clinical study of any investigational drug within 30 days prior to or during the course of the study.
13. Previous allocation of randomization code in this study.
14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show that Symbicort pMDI 40/2.25 µg two actuations b.i.d.(delivered dose) is more efficacious than Pulmicort Turbuhaler 100 µg one inhalation b.i.d. (metered dose) over a 6-week treatment period in adolescents and adults with asthma;Secondary Objective: 1. To compare the efficacy of Symbicort pMDI 40/2.5 µg two actuations b.i.d. <br>with that of Symbicort Turbuhaler 80/4.5 µg one inhalation b.i.d. over a 6-week treatment period in adolescents and adult<br><br>2. To investigate the safety profile of Symbicort pMDI 40/2.5 µg two actuations b.i.d. with that of Symbicort Turbuhaler 80/4.5 µg one inhalation b.i.d. and Pulmicort Turbuhaler 100 µg one inhalation b.i.d. (metered dose) over a 6-week treatment period in adolescents and adults with mild persistent asthma ;Primary end point(s): morning peak expiratory flow (mPEF)