SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

Study Overview
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Brief Summary
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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.

Official Title
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SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)

Conditions
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Asthma

Intervention / Treatment
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* Drug: Seretide
* Drug: Flixotide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seretide<br>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. | Drug: Seretide<br>* Seretide<br>|
| Experimental: Flixotide<br>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. | Drug: Flixotide<br>* Flixotide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Each Arm With a Need for an Increase in Study Medication | During the first 6 months, when the asthma was unstable/uncontrolled, dose of Seretide (Sal/FP) was increased from 50/100 mcg in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). Also, dose of Flixotide (FP only), was increased from 100 mcg 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. Number of participants in each arm with a need for an increase in study medication are presented. | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Bronchial Hyper-responsiveness up to 18 Months | Data for this outcome measure was not collected. | Up to 18 months | 
| Change in Bronchial Hyper-responsiveness From Baseline to 18 Months | Data for this outcome measure was not collected. | Baseline (Day 0) to 18 months | 
| Number of Symptom-free Days and Nights Without Use of Rescue Medication | The rescue medications used for exacerbations included Ventoline Diskus® 200 mcg/dose inhalations as required and oral Prednisolone 25 mg per day for five days, and when necessary, ten days. Data for this outcome measure was not collected. | Up to 18 months | 
| Number of Exacerbations: in Total and by Degree of Severity | Severe exacerbation: needed hospitalization/emergency unit visit. Moderate exacerbation: Needed oral cortico-steroid or adding inhaled Flixotide to maintenance study medicine; decrease in morning or evening peak expiratory flow (PEF) > 30% during ≥ 2 following days from Baseline (Day 0). Mild exacerbation: any night symptoms ≥ 3 consecutive, or night symptoms ≥ 2 consecutive nights in case symptoms have been scored ≥ 2 during at least one night, Day symptoms scored ≥ 2 during ≥ 4 following days, or Day symptoms scored ≥ 3 during ≥ 3 following days, or Day symptoms scored ≥ 4 during ≥ 2 following days, or rescue medication use ≥ 2 occasions per day for ≥ 4 following days, or rescue medication use ≥ 3 occasions per day for ≥ 3 following days, or rescue medication use ≥ 4 occasions per day for ≥ 2 following days, or decrease in morning/evening PEF >20% during ≥ 2 following days from Baseline (Day 0). Number of total exacerbations and severe, moderate and mild exacerbations are presented. | Up to 18 months | 
| Time to Increase of Study Medication | Data for this outcome measure was not collected. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, exacerbation, persistent, bronchial hyperresponsiveness, mild, GINAII