- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00455923
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
January 9, 2018 updated by: GlaxoSmithKline
SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Luleå, Sweden, SE-971 89
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Seretide
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.
|
Seretide
|
Experimental: 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.
|
Flixotide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants in Each Arm With a Need for an Increase in Study Medication
Time Frame: 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.
|
Up to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Bronchial Hyper-responsiveness up to 18 Months
Time Frame: Up to 18 months
|
Data for this outcome measure was not collected.
|
Up to 18 months
|
Change in Bronchial Hyper-responsiveness From Baseline to 18 Months
Time Frame: Baseline (Day 0) to 18 months
|
Data for this outcome measure was not collected.
|
Baseline (Day 0) to 18 months
|
Number of Symptom-free Days and Nights Without Use of Rescue Medication
Time Frame: Up to 18 months
|
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.
|
Up to 18 months
|
Number of Exacerbations: in Total and by Degree of Severity
Time Frame: 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 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.
|
Up to 18 months
|
Time to Increase of Study Medication
Time Frame: Up to 6 months
|
Data for this outcome measure was not collected.
|
Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 3, 2005
Primary Completion (Actual)
July 31, 2007
Study Completion (Actual)
July 31, 2007
Study Registration Dates
First Submitted
April 3, 2007
First Submitted That Met QC Criteria
April 3, 2007
First Posted (Estimate)
April 4, 2007
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
January 9, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Sympathomimetics
- Fluticasone
- Fluticasone-Salmeterol Drug Combination
Other Study ID Numbers
- SAM103976
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarRecruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Seretide
-
Brian J LipworthCompleted
-
GlaxoSmithKlineCompleted
-
Far Eastern Memorial HospitalCompleted
-
GlaxoSmithKlineCompleted
-
Orion Corporation, Orion PharmaCompleted
-
Merck Sharp & Dohme LLCCompletedAcute Bacterial Skin and Skin Structure InfectionsUnited States, Brazil, Bulgaria, Georgia, Germany, Guatemala, Latvia, Lithuania, Mexico, Poland, Russian Federation, South Africa, Turkey, Ukraine
-
Orion Corporation, Orion PharmaCompleted
-
Queen's UniversityWithdrawnEndophthalmitisCanada
-
Taipei Veterans General Hospital, TaiwanNational Taiwan University Hospital; Far Eastern Memorial HospitalUnknownChronic Obstructive Pulmonary DiseaseTaiwan
-
Kayseri City HospitalSaglik Bilimleri UniversitesiCompleted