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.

September 13, 2016 updated by: GlaxoSmithKline

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

669

Phase

  • Phase 2

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

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
        • GSK Investigational Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • GSK Investigational Site
      • Sofia, Bulgaria, 1606
        • GSK Investigational Site
      • Sofia, Bulgaria, 1431/1000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1619
        • GSK Investigational Site
      • Varna, Bulgaria, 9010
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7500551
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500691
        • GSK Investigational Site
  • Croatia
      • Osijek, Croatia, 31000
        • GSK Investigational Site
      • Split, Croatia, 21000
        • GSK Investigational Site
      • Zagreb, Croatia, 10000
        • GSK Investigational Site
  • Estonia
      • Kohtal-Jdrve, Estonia, 31 025
        • GSK Investigational Site
      • Parnu, Estonia, 80024
        • GSK Investigational Site
      • Tallinn, Estonia, 1162
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13086
        • GSK Investigational Site
      • Berlin, Germany, 10717
        • GSK Investigational Site
      • Berlin, Germany, 13597
        • GSK Investigational Site
      • Berlin, Germany, 10969
        • GSK Investigational Site
      • Berlin, Germany, 10365
        • GSK Investigational Site
      • Berlin, Germany, 10585
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Schwetzingen, Baden-Wuerttemberg, Germany, 68723
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Hessen
      • Eschwege, Hessen, Germany, 37269
        • GSK Investigational Site
      • Gelnhausen, Hessen, Germany, 63571
        • GSK Investigational Site
      • Kassel, Hessen, Germany, 34117
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germany, 30167
        • GSK Investigational Site
      • Lueneburg, Niedersachsen, Germany, 21335
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Guetersloh, Nordrhein-Westfalen, Germany, 33330
        • GSK Investigational Site
    • Sachsen
      • Annaberg, Sachsen, Germany, 09456
        • GSK Investigational Site
      • Aue, Sachsen, Germany, 08280
        • GSK Investigational Site
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany, 21502
        • GSK Investigational Site
    • Thueringen
      • Erfurt, Thueringen, Germany, 99084
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 28
        • GSK Investigational Site
      • Athens, Greece, 15669
        • GSK Investigational Site
      • Papagos/Athens, Greece, 15669
        • GSK Investigational Site
  • Hungary
      • Törökbálint, Hungary, 2045
        • GSK Investigational Site
  • Italy
    • Campania
      • Eboli (SA), Campania, Italy, 84025
        • GSK Investigational Site
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
      • Salerno, Campania, Italy, 84126
        • GSK Investigational Site
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44100
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Lombardia
      • Sesto San Giovanni (MI), Lombardia, Italy, 20099
        • GSK Investigational Site
    • Marche
      • Torrette (AN), Marche, Italy, 60126
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • GSK Investigational Site
      • Pisa, Toscana, Italy, 56124
        • GSK Investigational Site
    • Veneto
      • Bussolengo (VR), Veneto, Italy, 37012
        • GSK Investigational Site
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 04530
        • GSK Investigational Site
      • Mexico, D.F., Mexico, 06720
        • GSK Investigational Site
  • Romania
      • Brasov, Romania
        • GSK Investigational Site
      • Bucharest, Romania, 050159
        • GSK Investigational Site
      • Bucuresti, Romania, 70000
        • GSK Investigational Site
  • Russian Federation
      • Kazan, Russian Federation, 420015
        • GSK Investigational Site
      • Moscow, Russian Federation, 115446
        • GSK Investigational Site
      • Moscow, Russian Federation, 115478
        • GSK Investigational Site
      • Moscow, Russian Federation, 123 182
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197 089
        • GSK Investigational Site
      • Tomsk, Russian Federation, 634 050
        • GSK Investigational Site
      • Volgograd, Russian Federation, 400130
        • GSK Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9300
        • GSK Investigational Site
      • Cape Town, South Africa, 7500
        • 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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
Drug: GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
Drug: GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Drug: Placebo
Placebo inhaled twice daily (morning and evening) for 28 days
Experimental: GW685698X (fluticasone furoate) 100mcg Morning
Drug: GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
Experimental: GW685698X (fluticasone furoate) 100mcg Evening
Drug: GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
Experimental: GW685698X (fluticasone furoate) 250mcg Evening
Drug: GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak expiratory flow (PEF)
Time Frame: 28 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak expiratory flow (PEF)
Time Frame: 28 days
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
PEF
Time Frame: 28 days
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
Clinic lung function
Time Frame: 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

September 1, 2003

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFA20001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: FFA20001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: FFA20001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: FFA20001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: FFA20001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: FFA20001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: FFA20001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: FFA20001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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.

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