Last updated: 11/07/2018 16:41:20
A study of GW685698X 100mcg administered once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, double-blind, double dummy, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GW685698X 100mcg administered once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening all administered by inhalation via DISKHALER for 28 days in subjects with persistent bronchial asthma.
Trial description: The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Peak expiratory flow (PEF)
Timeframe: 28 days
Secondary outcomes:
Peak expiratory flow (PEF)
Timeframe: 28 days
PEF
Timeframe: 28 days
Clinic lung function
Timeframe: 28 days
Interventions:
Drug: GW685698X (fluticasone furoate) 100mcg Morning
Drug: GW685698X (fluticasone furoate) 100mcg Evening
Drug: GW685698X (fluticasone furoate) 250mcg Evening
Drug: Placebo
Enrollment:
669
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Medley H, Orozco S, Allen A. Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma. Clin Ther. 2012;34(8):1683–1695.
Medical condition
Asthma
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
September 2003 to March 2004
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
16 - 65 years
Accepts healthy volunteers
No
- Outpatients aged between 16- 65 years.
- Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
- History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatients aged between 16- 65 years.
- Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
- Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1
- Currently receiving inhaled short-acting beta-2 agonists for symptom relief
- A lung function of between 50 to 90% predicted (PEF)
- Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol
Exclusion criteria:
- History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1.
- Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia).
- Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose).
- Undergoing allergen desensitisation therapy.
- Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject’s proper completion of the protocol requirements.
- Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit.
Trial location(s)
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lueneburg, Niedersachsen, Germany, 21335
Status
Study Complete
Location
GSK Investigational Site
Torrette (AN), Marche, Italy, 60126
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33330
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30167
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Sesto San Giovanni (MI), Lombardia, Italy, 20099
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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