Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01498679
First received: December 21, 2011
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid or low-strength combination therapy.


Condition Intervention Phase
Asthma
Drug: GW685698/GW642444
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate (FF/VI) Inhalation Powder Delivered Once Daily for 12 Weeks in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry Currently Treated With Low to Mid-strength Inhaled Corticosteroid or Low-strength Combination Therapy.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline in PM PEF averaged over the 12 week treatment period [ Time Frame: averaged over the 12 week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in daily AM PEF averaged over the 12 week treatment period [ Time Frame: averaged over 12 week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in percentage of rescue free 24 hour periods during the 12 week treatment period [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in the percentage of symptom free 24 hour periods during the 12 week treatment period [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in total AQLQ score at week 12 [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 302
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fluticasone furoate/vilanterol trifenatate
ICS/LABA combination
Drug: GW685698/GW642444
ICS/LABA combination
Placebo Comparator: Placebo
placebo comparator
Drug: Placebo
Placebo

Detailed Description:

This will be a randomised, double-blind, placebo controlled, parallel group, multi-centre study. At Visit 1 (Screening Visit) subjects who meet all of the inclusion criteria and none of the exclusion criteria will enter a two week run-in period. Subjects will remain on their current ICS therapy throughout the run-in period. At the end of the run-in period (Visit 2) subjects meeting the Randomisation criteria will enter a 12 week treatment period and receive one of the two following treatments: 1) FF/VI (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) 2) Placebo administered once daily in the evening via a NDPI In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to be used as required to treat asthma symptoms.

Subjects who have not met the randomisation criteria at Visit 2 will be withdrawn from the study.

Subjects meeting the randomisation criteria will be randomized to one of the two treatment groups and will attend the clinic for 3 on-treatment visits at Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5). Subjects will receive treatment for 12 weeks. A Follow-up Visit or phone call (Visit 6) will take place 1 week after completing study medication. All clinic visits will take place in the morning. Subjects will participate in the study for a maximum of 15 weeks (Screening to Follow-up inclusive). A subject is regarded to have completed the study if they complete all phases of the study (Screening, treatment, Follow-up).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study.
  2. Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1 (or ≥18 years of age or older if local regulations or the regulatory status of study medication permit enrolment of adults only), with a diagnosis of asthma as defined by the Global Initiative for Asthma [GINA, 2009] at least 12 weeks prior to Visit 1.
  3. Gender: Male or Eligible Female, defined as non-childbearing potential or childbearing potential using a protocol defined acceptable method of birth control consistently and correctly. Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required for females of childbearing potential at the initial Screening Visit (Visit 1) and Visit 5 or Early Withdrawal
  4. Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value at the Visit 1, Screening visit. Predicted values will be based upon NHANES III using the adjustment for Asians [Hankinson, 2010].
  5. Reversibility of Disease: Demonstrated ≥12% and ≥200mL reversibility of FEV1 within 10-40minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or one nebulised treatment with albuterol/salbutamol solution) at the Screening Visit.
  6. Current Anti-Asthma Therapy: All subjects must be using an ICS, with or without LABA, for at least 12 weeks prior to Visit 1, in accordance with the protocol defined acceptable dose ranges.
  7. Short-Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhaler at Visit 1 for use as needed for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 4 hours prior to study visits

Exclusion Criteria:

  1. History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years.
  2. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
  3. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
  4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
  5. Other Concurrent Diseases/Abnormalities: A subjects must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
  6. Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of candidiasis at Visit 1.
  7. Allergies: •Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate). •Milk Protein Allergy: History of severe milk protein allergy.
  8. Concomitant Medications: Use of the protocol defined prohibited medications prior to Screening (Visit 1) or during the study, in accordance with the protocol.
  9. Tobacco Use: Current smoker or subjects with a smoking history of 10 pack years (e.g., 20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, smokeless or pipe tobacco).
  10. Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, Sub Investigator, study coordinator, or employee of the participating Investigator.
  11. Previous Participation: A subject may not have previously been Randomized to treatment in another Phase III fluticasone furoate/VI combination product study (i.e., HZA113714, HZA106827, HZA106829, HZA106837, HZA106839, HZA106851, HZA113091).
  12. Compliance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or grographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498679

Locations
China, Guangdong
GSK Investigational Site
Shenzhen, Guangdong, China, 518020
GSK Investigational Site
Zhanjiang, Guangdong, China, 524001
China, Guangxi
GSK Investigational Site
Nanning, Guangxi, China, 530021
China, Hainan
GSK Investigational Site
Haikou, Hainan, China, 570311
China, Liaoning
GSK Investigational Site
Shenyang, Liaoning, China, 110015
China, Ningxia
GSK Investigational Site
Yinchuan, Ningxia, China, 750004
China, Shaanxi
GSK Investigational Site
Xian, Shaanxi, China, 710032
China, Shandong
GSK Investigational Site
Qingdao, Shandong, China, 266071
China, Zhejiang
GSK Investigational Site
Hang Zhou, Zhejiang, China, 310003
China
GSK Investigational Site
Beijing, China, 100029
GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Beijing, China, 100050
GSK Investigational Site
Chongqing, China, 400037
GSK Investigational Site
Chongqing, China
GSK Investigational Site
Hangzhou, China, 310016
GSK Investigational Site
Shanghai, China, 200433
Korea, Republic of
GSK Investigational Site
Cheongju, Chungcheongbuk-do, Korea, Republic of, 361-711
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of, 152-703
Philippines
GSK Investigational Site
Marilao, Bulacan, Philippines, 3019
GSK Investigational Site
Quezon City, Philippines, 1101
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01498679     History of Changes
Other Study ID Numbers: 113719
Study First Received: December 21, 2011
Last Updated: June 12, 2013
Health Authority: China: Food and Drug Administration
Philippines: Food and Drug Administration Philippines
South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013