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A Study to Assess the Bronchodilator Effect of a Single Dose of Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 Micrograms (mcg) Combination When Administered in Adult Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837316
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The study will be a randomized, double-blind, placebo controlled cross-over study in 32 adult subjects with moderately severe asthma. In this study the bronchodilator effect of a single morning dosing of FF/VI combination 100/25 mcg will be determined by spirometry. After the screening the subject will be randomized and will be assigned to one of two treatment sequences (AB or BA, where A is placebo and B is FF/VI 100/25 mcg). Between the two treatment periods there will be a washout period of 7-14 days. A serial forced expiratory volume in one second (FEV1) measurements will be taken at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and 72 hours post dose. Safety assessments will include vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests however, these will not constitute study endpoints. The results of the study will provide supporting information to prescribers on the bronchodilator effect of FF/VI over 72 hours.

Condition or disease Intervention/treatment Phase
Asthma Drug: FF/VI 100/25 mcg Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Cross-over Study to Determine the Bronchodilator Effect of a Single Dose of Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 mcg Combination Administered in the Morning in Adult Patients With Asthma
Actual Study Start Date : October 21, 2013
Actual Primary Completion Date : August 8, 2014
Actual Study Completion Date : August 8, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: FF/VI
A single dose inhalation of FF/VI 100/25 mcg in the morning
Drug: FF/VI 100/25 mcg
First strip: Fluticasone furoate inhalation powder blended with lactose, 100 mcg per blister

Placebo Comparator: Placebo
A single dose inhalation of matching placebo in the morning
Drug: Placebo
First strip: Inhalation powder of lactose




Primary Outcome Measures :
  1. Change from baseline in FEV1 at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and 72 hours post dose. [ Time Frame: Baseline (pre dose) and 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and 72 hours post dose in each treatment period ]
    Change from baseline in FEV1 at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and 72 hours post dose. Day 1 Baseline will be defined as Day 1 pre dose measurement for FEV1 for each treatment period.


Secondary Outcome Measures :
  1. Time to onset of bronchodilator effect of FF/VI 100/25 mcg [ Time Frame: Baseline, 15, 30 minutes, 1, 2, 4 hours post dose in each treatment period ]
    The time to onset of bronchodilator effect is defined as the time point when FEV1 first meets or exceeds 12% and 200 mL over baseline during the 0-4 hour serial measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma: A doctor diagnosis of asthma.
  • Age of subject: 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Severity of Disease: A screening pre-bronchodilator FEV1 >=60% of predicted.
  • Reversibility of Disease: Demonstrated presence of reversible airway disease at screening.
  • Current Therapy: On inhaled corticosteroid (ICS) with or without a SABA for at least 12 weeks prior to screening. Able to stop current Short-Acting Beta2-Agonists (SABA) and replace with albuterol/salbutamol inhaler
  • Body weight and BMI: Body weight >=50 kilogram (kg) and Body Mass Index (BMI) within the range 19.0 to 29.9 kilogram per square meter (kg/m^2) (inclusive).
  • Gender: Male or female. A female subject is eligible to participate if she is of:

Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.

Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow-up visit.

  • Liver criteria: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <2x Upper limit of normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Consent: Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • A history of life-threatening asthma.
  • Other significant pulmonary diseases: pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
  • 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 screening that; 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.
  • Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening.
  • Concomitant Medications: Use of the medications, ICS were prohibited for each study period from 24 hours prior to dosing to 72 hours after dosing; Long acting beta agonist (LABA), leukotriene receptor antagonist (LTRA) or long acting muscarinic anatagonist (LAMA) were prohibited for 12 weeks prior to screening; High doses of an ICS were prohibited for 8 weeks prior to screening; Oral steroids were prohibited for 12 weeks prior to screening; Potent CYPP3A4 inhibitors were prohibited within 4 weeks prior to dosing. The following medications may not be used during the study from first dosing to the end of period 2 inclusive: Anticonvulsants, Polycyclic antidepressants, β-adrenergic blocking agents, Phenothiazines and Monoamine oxidase (MAO) inhibitors.
  • Other concurrent Diseases/Abnormalities: A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the study results if the condition/disease exacerbated during the study.
  • Oropharyngeal examination: A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening.
  • Pregnancy and Lactating Females:Pregnant females as determined by positive serum human chorionic gonadotropin (hCG) test at screening or by positive urine hCG test prior to dosing. Lactating females.
  • Allergies: Milk Protein Allergy: History of severe milk protein allergy. 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 dry powder inhaler (DPI) (i.e., lactose or magnesium stearate). Historical Allergy: History of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • 12-Lead ECG abnormality: Significant abnormality in the 12-lead electrocardiogram (ECG) performed at screening.
  • Tobacco Use: Current smokers or a smoking history of >=10 pack years. A subject may not have used any inhaled tobacco products in the 12 month period preceding the screening visit.
  • Previous Participation: Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837316


Locations
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New Zealand
GSK Investigational Site
Wellington, New Zealand, 6021
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 116592
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 116592
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 116592
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 116592
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 116592
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 116592
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 116592
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01837316    
Other Study ID Numbers: 116592
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by GlaxoSmithKline:
pharmacodynamics
FF/VI
asthma
duration of action
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents