NCT00455923

SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

Completed Phase 4 Results posted Last updated 5 February 2018

What this trial tests

Phase 4 trial testing Seretide in Asthma in 100 participants. Completed in 31 July 2007.

Timeline

3 May 2005

Primary endpoint
31 July 2007

31 July 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	treatment
Enrollment	100
Start date	3 May 2005
Primary completion	31 July 2007
Estimated completion	31 July 2007
Sites	1 location across Sweden

Drugs / interventions tested

• Seretide — full drug profile →
• Flixotide — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 70, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants in Each Arm With a Need for an Increase in Study Medication Primary · Up to 18 months

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.

Group	Value	95% CI
Seretide	29
Flixotide	29

Number of Exacerbations: in Total and by Degree of Severity Secondary · Up to 18 months

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 follow

Total exacerbations

Group	Value	95% CI
Seretide	42
Flixotide	74

Severe exacerbations

Group	Value	95% CI
Seretide	0
Flixotide	1

Moderate exacerbations

Group	Value	95% CI
Seretide	12
Flixotide	21

Mild exacerbations

Group	Value	95% CI
Seretide	30
Flixotide	52

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 18 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Seretide

Serious: 3/50 (6%)

Deaths: 0/50

Flixotide

Serious: 0/50 (0%)

Deaths: 0/50

Serious adverse events (3 terms)

Reaction	System	Seretide	Flixotide
Colon diverticulitis	Gastrointestinal disorders	—	—
Migraine/headache	Nervous system disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Seretide	Flixotide
Common cold	Infections and infestations	—	—
Upper airway infections	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Pharyngitis	Infections and infestations	—	—
Bronchitis	Infections and infestations	—	—
Upper back pain	Musculoskeletal and connective tissue disorders	—	—
Chest pain	General disorders	—	—
Mouth candida	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—

Most-reported serious reactions: Colon diverticulitis, Migraine/headache, Cholecystitis.

Data from ClinicalTrials.gov NCT00455923 adverse events section.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.