Clinical trial NCT01499446: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 669
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Peak expiratory flow (PEF)
timeFrame: 28 days
Secondary outcomes:
measure: Peak expiratory flow (PEF)
timeFrame: 28 days
measure: PEF
timeFrame: 28 days
measure: Clinic lung function
timeFrame: 28 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Osijek
country: Croatia
facility: GSK Investigational Site
city: Split
country: Croatia
facility: GSK Investigational Site
city: Zagreb
country: Croatia
facility: GSK Investigational Site
city: Kohtal-Jdrve
country: Estonia
facility: GSK Investigational Site
city: Parnu
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Schwetzingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Eschwege
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Gelnhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Lueneburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Guetersloh
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Annaberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Aue
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Papagos/Athens
country: Greece
facility: GSK Investigational Site
city: Törökbálint
country: Hungary
facility: GSK Investigational Site
city: Eboli (SA)
country: Italy
facility: GSK Investigational Site
state: Campania
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Salerno
country: Italy
facility: GSK Investigational Site
state: Campania
city: Ferrara
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Sesto San Giovanni (MI)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Torrette (AN)
country: Italy
facility: GSK Investigational Site
state: Marche
city: Firenze
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Bussolengo (VR)
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Padova
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucuresti
country: Romania
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Volgograd
country: Russian Federation
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
citation: 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 Aug;34(8):1683-95. doi: 10.1016/j.clinthera.2012.06.024. Epub 2012 Jul 13.