Clinical trial · Interventional
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flixotide | Drug | — | UNRESOLVED |
| Seretide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Seretide
- 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.
- interventionNames
- Drug: Seretide
- type
- EXPERIMENTAL
- label
- Flixotide
- 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.
- interventionNames
- Drug: Flixotide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
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