SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

NCT ID: NCT00455923

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-03
• Study Completion Date: 2007-07-31

Brief Summary

An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Seretide

Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.

Group Type: EXPERIMENTAL

Seretide

Intervention Type: DRUG

Seretide

Flixotide

Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.

Group Type: EXPERIMENTAL

Flixotide

Intervention Type: DRUG

Flixotide

Interventions

Seretide

Seretide

Intervention Type: DRUG

Flixotide

Flixotide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing to give informed consent.
• Males or females aged 18-70.
• Able to understand and complete dairy cards.
• Mild persistent asthma according to GINA. In addition, at randomisation subjects were required to have: 1. Day time symptoms more than once a week but not every day. 2. Night-time symptoms not more than once a week. 3. FEV1 >80% predicted 4. PC20 <8mg/mL

Exclusion Criteria

• Change to regular asthma medication in 4-weeks prior to visit 1.
• Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
• Lower respiratory tract within 4 weeks of Visit 1
• Received investigational study drug within 4 weeks of visit
• Smoking history of >10 pack years of more.
• Serious uncontrolled disease.
• Medical conditions or medications known to affect the assessments or endpoints.
• Evidence of alcohol or drug abuse.
• Known pregnancy or planned pregnancy.
• Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
• Previous enrollment in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Luleå, , Sweden

Countries

Sweden

Other Identifiers

SAM103976

Identifier Type: -

Identifier Source: org_study_id