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.

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499446
• Other study ID #: FFA20001
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2011
• Last updated: September 13, 2016
• Start date: September 2003
• Est. completion date: March 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeBulgaria: LECRussia: Ethics CommitteeRomania: Agentia Nationala a MedicamentuluiItaly: Ethics CommitteeEstonia: ERC on Human Research of the University of TartuRomania: Minister of HealthChile: Comite de Etica Cientifica Servicio de Salud Metropolitano OrienteCroatia: Ministry of health and Social WelfareGermany: Berlin Ethics CommitteeGreece: National Drug Organisation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 669
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
• GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
• GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
• Placebo
Placebo inhaled twice daily (morning and evening) for 28 days

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Croatia	GSK Investigational Site	Osijek
Croatia	GSK Investigational Site	Split
Croatia	GSK Investigational Site	Zagreb
Estonia	GSK Investigational Site	Kohtal-Jdrve
Estonia	GSK Investigational Site	Parnu
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Annaberg	Sachsen
Germany	GSK Investigational Site	Aue	Sachsen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Erfurt	Thueringen
Germany	GSK Investigational Site	Eschwege	Hessen
Germany	GSK Investigational Site	Geesthacht	Schleswig-Holstein
Germany	GSK Investigational Site	Gelnhausen	Hessen
Germany	GSK Investigational Site	Guetersloh	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Lueneburg	Niedersachsen
Germany	GSK Investigational Site	Schwetzingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Papagos/Athens
Hungary	GSK Investigational Site	Törökbálint
Italy	GSK Investigational Site	Bussolengo (VR)	Veneto
Italy	GSK Investigational Site	Eboli (SA)	Campania
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Salerno	Campania
Italy	GSK Investigational Site	Sesto San Giovanni (MI)	Lombardia
Italy	GSK Investigational Site	Torrette (AN)	Marche
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Mexico, D.F.
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucuresti
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Volgograd
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Brazil,  Bulgaria,  Chile,  Croatia,  Estonia,  Germany,  Greece,  Hungary,  Italy,  Mexico,  Romania,  Russian Federation,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak expiratory flow (PEF)	Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.	28 days	No
Secondary	Peak expiratory flow (PEF)	Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 250mcg once daily compared with GW685698X 100mcg once daily both administered in the evening by inhalation via DISKHALER.	28 days	No
Secondary	PEF	Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning, 100mcg once daily in the evening, or GW685698X 250mcg once daily in the evening, compared with placebo	28 days	No
Secondary	Clinic lung function	Change from baseline in pre bronchodilator clinic lung function (forced expiratory volume in 1 second [FEV1] and PEF) after 28 days of treatment with GW685698X 250mcg once daily in the evening compared with GW685698X 100mcg once daily in the evening	28 days	No

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.