Back to resultsSERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Seretide
Flixotide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, exacerbation, persistent, bronchial hyperresponsiveness, mild, GINAII
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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Seretide
Flixotide
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Absolute Bronchial Hyper-responsiveness up to 18 Months
Data for this outcome measure was not collected.
Change in Bronchial Hyper-responsiveness From Baseline to 18 Months
Data for this outcome measure was not collected.
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.
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.
Time to Increase of Study Medication
Data for this outcome measure was not collected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00455923
Brief Title
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Official Title
SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 3, 2005 (Actual)
Primary Completion Date
July 31, 2007 (Actual)
Study Completion Date
July 31, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, exacerbation, persistent, bronchial hyperresponsiveness, mild, GINAII
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seretide
Arm Type
Experimental
Arm Description
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.
Arm Title
Flixotide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Seretide
Intervention Description
Seretide
Intervention Type
Drug
Intervention Name(s)
Flixotide
Intervention Description
Flixotide
Primary Outcome Measure Information:
Title
Number of Participants in Each Arm With a Need for an Increase in Study Medication
Description
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.
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Absolute Bronchial Hyper-responsiveness up to 18 Months
Description
Data for this outcome measure was not collected.
Time Frame
Up to 18 months
Title
Change in Bronchial Hyper-responsiveness From Baseline to 18 Months
Description
Data for this outcome measure was not collected.
Time Frame
Baseline (Day 0) to 18 months
Title
Number of Symptom-free Days and Nights Without Use of Rescue Medication
Description
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.
Time Frame
Up to 18 months
Title
Number of Exacerbations: in Total and by Degree of Severity
Description
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.
Time Frame
Up to 18 months
Title
Time to Increase of Study Medication
Description
Data for this outcome measure was not collected.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Luleå
ZIP/Postal Code
SE-971 89
Country
Sweden
12. IPD Sharing Statement
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SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
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