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
Completed
Completed
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:
Drug: Seretide
Drug: Flixotide
Enrollment:
100
Observational study model:
Not applicable
Primary completion date:
2007-31-07
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
Completed
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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