Phase 4
N=100
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00455923 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants in Each Arm With a Need for an Increase in Study Medication — 29; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Seretide (Drug); Flixotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Each Arm With a Need for an Increase in Study Medication |
29; 29 | — |
| SECONDARY Absolute Bronchial Hyper-responsiveness up to 18 Months |
— | — |
| SECONDARY Change in Bronchial Hyper-responsiveness From Baseline to 18 Months |
— | — |
| SECONDARY Number of Symptom-free Days and Nights Without Use of Rescue Medication |
— | — |
| SECONDARY Number of Exacerbations: in Total and by Degree of Severity |
42; 74; 0; 1; 12; 21 | — |
| SECONDARY Time to Increase of Study Medication |
— | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00455923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.