Trial Outcomes & Findings for SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII) (NCT NCT00455923)
NCT ID: NCT00455923
Last Updated: 2018-02-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2018-02-05
Participant Flow
This study was conducted at a single center with two sites in Sweden from May 2005 to July 2007. Seretide Diskus®, Flixotide® and Ventoline Diskus® are the registered products of GlaxoSmithKline.
Participant milestones
| Measure |
Seretide
Eligible participants received a starting dose of 50/100 micrograms (mcg) Seretide (combination of salmeterol/fluticasone propionate (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.
|
Flixotide
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Seretide
Eligible participants received a starting dose of 50/100 micrograms (mcg) Seretide (combination of salmeterol/fluticasone propionate (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.
|
Flixotide
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.
|
|---|---|---|
|
Overall Study
Pregnancy
|
0
|
2
|
|
Overall Study
Other
|
3
|
1
|
Baseline Characteristics
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Baseline characteristics by cohort
| Measure |
Seretide
n=50 Participants
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.
|
Flixotide
n=50 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 to 70 years
|
50 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
100 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
100 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: Intent-to-Treat (ITT) Population which comprised of all participants who were randomized and received at least one dose of the study medication.
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.
Outcome measures
| Measure |
Seretide
n=50 Participants
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.
|
Flixotide
n=50 Participants
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.
|
|---|---|---|
|
Number of Participants in Each Arm With a Need for an Increase in Study Medication
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Data for this outcome measure was not collected.
Data for this outcome measure was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to 18 monthsPopulation: ITT population. Data for this outcome measure was not collected.
Data for this outcome measure was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: ITT population. Data for this outcome measure was not collected.
The rescue medications used for exacerbations included Ventoline Diskus® 200 mcg/dose inhalations as required and oral Prednisolone 25 mg per day for five days, and when necessary, ten days. Data for this outcome measure was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: ITT Population.
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 following days, or rescue medication use ≥ 2 occasions per day for ≥ 4 following days, or rescue medication use ≥ 3 occasions per day for ≥ 3 following days, or rescue medication use ≥ 4 occasions per day for ≥ 2 following days, or decrease in morning/evening PEF \>20% during ≥ 2 following days from Baseline (Day 0). Number of total exacerbations and severe, moderate and mild exacerbations are presented.
Outcome measures
| Measure |
Seretide
n=50 Participants
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.
|
Flixotide
n=50 Participants
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.
|
|---|---|---|
|
Number of Exacerbations: in Total and by Degree of Severity
Total exacerbations
|
42 Exacerbations
|
74 Exacerbations
|
|
Number of Exacerbations: in Total and by Degree of Severity
Mild exacerbations
|
30 Exacerbations
|
52 Exacerbations
|
|
Number of Exacerbations: in Total and by Degree of Severity
Severe exacerbations
|
0 Exacerbations
|
1 Exacerbations
|
|
Number of Exacerbations: in Total and by Degree of Severity
Moderate exacerbations
|
12 Exacerbations
|
21 Exacerbations
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: ITT population. Data for this outcome measure was not collected.
Data for this outcome measure was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Seretide
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Flixotide
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Seretide
n=50 participants at risk
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.
|
Flixotide
n=50 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Colon diverticulitis
|
2.0%
1/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
0.00%
0/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Nervous system disorders
Migraine/headache
|
2.0%
1/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
0.00%
0/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
0.00%
0/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
Other adverse events
| Measure |
Seretide
n=50 participants at risk
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.
|
Flixotide
n=50 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Common cold
|
90.0%
45/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
78.0%
39/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Infections and infestations
Upper airway infections
|
28.0%
14/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
30.0%
15/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Nervous system disorders
Headache
|
16.0%
8/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
14.0%
7/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Infections and infestations
Gastroenteritis
|
18.0%
9/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
16.0%
8/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Infections and infestations
Pharyngitis
|
14.0%
7/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
8.0%
4/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Infections and infestations
Bronchitis
|
8.0%
4/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
10.0%
5/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Infections and infestations
Mouth candida
|
4.0%
2/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
8.0%
4/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Infections and infestations
Sinusitis
|
6.0%
3/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
2.0%
1/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Upper back pain
|
8.0%
4/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
10.0%
5/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
|
General disorders
Chest pain
|
2.0%
1/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
10.0%
5/50 • Up to 18 months
Adverse events (Serious adverse events and non-serious adverse events) were collected and are reported for the ITT Population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER