A comparative study of SymbicortÂ® Maintenance and Reliever Therapy (Symbicort TurbuhalerÂ® 160/4.5 mg, one inhalation bid plus as-needed) and Symbicort Turbuhaler 160/4.5 mg, one inhalation bid plus Terbutaline Turbuhaler 0.4 mg/inhalation as-needed, for treatment of asthma.

A comparison of SymbicortÂ® Maintenance and Reliever Therapy (Symbicort TurbuhalerÂ® 160/4.5 mg, one inhalation bid plus as-needed) and Symbicort Turbuhaler 160/4.5 mg, one inhalation bid plus Terbutaline Turbuhaler 0.4 mg/inhalation as-needed, for treatment of asthma ? a 12-month, randomized, double-blind, parallel group, active-controlled, multinational, phase III study in asthmatic patients aged 16 years and above.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000240

Enrollment

1800

Registered

2009-07-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Asthma Health Condition 2: J459- Other and unspecified asthma

Interventions

Intervention1: Symbicort TurbuhalerÂ® 160/4.5 mcg and Symbicort Turbuhaler 160/4.5 mcg, one inhalation plus Terbutaline Turbuhaler 0.4 mcg: Symbicort TurbuhalerÂ® 160/4.5 mcg and Symbicort Turbuhaler

Eligibility

Inclusion criteria

Inclusion criteria: 1.Provision of signed and dated 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.Outpatients of either gender aged >=16 years 3.Diagnosis of asthma according to GINA 2007 with a documented history of at least 6 months duration prior to start of study 4.FEV1 Â³ 50% of predicted normal value pre-bronchodilator 5.Reversible airway obstruction defined as an increase in FEV1 >=12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline (delivered dose) Turbuhaler 6.Prescribed use of inhaled GCS (any brand) for at least 12 weeks prior to Visit 2

Exclusion criteria

Exclusion criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled. 1.Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks prior to Visit 2 2.Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks prior to Visit 2

Design outcomes

Primary

Measure	Time frame
EfficacyTimepoint: Time to first asthma exacerbation	—

Secondary

Measure	Time frame
Number of asthma exacerbationsMorning Peak Expiratory Flow (PEF)Evening Peak Expiratory FlowForced expiratory volume in one second (FEV1)Use of as-needed medicationAsthma symptom scoreNights with awakening(s) due to asthma symptomsDerived from diariesTime to first mild asthma exacerbationsNumber of mild asthma exacerbation daysPercentage of symptom-free daysPercentage of as-needed-free daysPercentage of asthma-control daysAsthma Control Questionnaire (ACQ)Timepoint: 52 weeks	—

Measure

Time frame

Number of asthma exacerbationsMorning Peak Expiratory Flow (PEF)Evening Peak Expiratory FlowForced expiratory volume in one second (FEV1)Use of as-needed medicationAsthma symptom scoreNights with awakening(s) due to asthma symptomsDerived from diariesTime to first mild asthma exacerbationsNumber of mild asthma exacerbation daysPercentage of symptom-free daysPercentage of as-needed-free daysPercentage of asthma-control daysAsthma Control Questionnaire (ACQ)Timepoint: 52 weeks

—

Countries

Argentina, Brazil, China, Costa Rica, Hungary, Japan, Malaysia, Peru, Philippines, Republic of Korea, Russian Federation, Thailand

Contacts

Public ContactRamesh Jagannathan

Metro Centre for Respiratory Diseases

dtlung@hotmail.com91989905000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026