A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (PASSION)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Symbicort TBH - Turbuhaler; Drug: beta-II-agonist, inhale steroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628758

D5890L00016

Details and patient eligibility

About

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.

Full description

A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Enrollment: 430 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
• Ability to read and write in Turkish
• Female or male outpatients aged 18 years
• Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
• Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1
• Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment

Exclusion criteria

• Previous treatment with Symbicort Single inhaler Therapy
• Use of any b-blocking agent, including eye drops
• Use of oral GCS as maintenance treatment
• Known or suspected hypersensitivity to study therapy or excipients
• A history of smoking 10 pack years
• Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
• Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Symbicort

Experimental group

Description:

Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)

Treatment:

Drug: Symbicort TBH - Turbuhaler

Conventional BP

Experimental group

Description:

Conventional Best Practice for Treatment of Asthma

Treatment:

Drug: beta-II-agonist, inhale steroid