Last updated: 11/04/2018 11:07:18
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
GSK study ID
SAM103976
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: SERETIDE vs FLIXOTIDE in mild persistent asthma (GINAII)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants in each arm with a need for an increase in study medication
Timeframe: Up to 18 months
Secondary outcomes:
Absolute bronchial hyper-responsiveness up to 18 months
Timeframe: Up to 18 months
Change in bronchial hyper-responsiveness from Baseline to 18 months
Timeframe: Baseline (Day 0) to 18 months
Number of symptom-free days and nights without use of rescue medication
Timeframe: Up to 18 months
Number of exacerbations: in total and by degree of severity
Timeframe: Up to 18 months
Time to increase of study medication
Timeframe: Up to 6 months
Interventions:
Enrollment:
100
Primary completion date:
2007-31-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
May 2005 to July 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Willing to give informed consent.
- Males or females aged 18-70.
- 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.
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-31-07
Actual study completion date
2007-31-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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