Last updated: 11/07/2018 11:04:04

Meta-Analysis Results Report for DB2116844: Meta-analysis of DB2113360 and DB2113374: an Integrated Review of Transition Dyspnoea Index data for Umeclidinium/Vilanterol, Umeclidinium, Vilanterol and Tiotropium over 24 Weeks in Subjects with COPD

GSK study ID
116844
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Meta-Analysis Results Report for DB2116844: Meta-analysis of DB2113360 and DB2113374: an Integrated Review of Transition Dyspnoea Index data for Umeclidinium/Vilanterol, Umeclidinium, Vilanterol and Tiotropium over 24 Weeks in Subjects with COPD
Trial description: Umeclidinium bromide/vilanterol inhalation powder (UMEC/VI) is a combination of two long-acting bronchodilators: the long-acting muscarinic antagonist UMEC and the long-acting beta2-agonist VI. UMEC/VI is under development for the once-daily treatment of COPD.
The primary objective of this analysis was to assess the effect of UMEC/VI, UMEC, VI and the long-acting muscarnic antagonist tiotropium on breathlessness due to COPD (also called dyspnoea) as measured by the Transition Dyspnea Index (TDI) focal score in subjects with COPD, using pooled data from two completed studies DB2113360 and DB2113374.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

TDI score

Timeframe: 168 days

Secondary outcomes:
Not applicable
Interventions:
  • Drug: UMEC 125mcg
  • Drug: UMEC/VI 125/25mcg
  • Drug: Tiotropium 18mcg
  • Drug: VI 25mcg
  • Drug: UMEC/VI 62.5/25mcg
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Decramer M, Anzueto A, Richard N, Harris S, Kalberg C, Church A.Effect of the Once-Daily Long-Acting Bronchodilator Combination Umeclidinium/Vilanterol and Bronchodilator Monotherapy on Dyspnea as Measured by the Transitional Dyspnoea Index (TDI) in COPD.ERJ.2014;44(Suppl. 56):P921
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    umeclidinium bromide, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    May 2012 to August 2012
    Type
    Observational
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    none
    • outpatient
    • signed and dated written informed consent
    • women who are pregnant or lactating or are planning on becoming pregnant during the study
    • current diagnosis of asthma
    Inclusion and exclusion criteria
    Inclusion criteria:
    • outpatient
    • signed and dated written informed consent
    • 40 years of age or older
    • male and female subjects
    • COPD diagnosis
    • at least 10 pack-year smoking history
    • post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of less than or equal to 70% predicted normal values
    • score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)
    Exclusion criteria:
    • women who are pregnant or lactating or are planning on becoming pregnant during the study
    • current diagnosis of asthma
    • other respiratory disorders other than COPD
    • other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
    • chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
    • hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
    • hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
    • lung volume reduction surgery within 12 months prior to Visit 1
    • abnormal and clinically significant ECG at Visit 1
    • significantly abnormal finding from laboratory tests at Visit 1
    • unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each visit
    • use of depot corticosteroids within 12 weeks of Visit 1
    • use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1
    • use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1
    • use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
    • initiation or discontinuation of ICS within 30 days of Visit 1
    • use of tiotropium or roflumilast within 14 days of Visit 1
    • use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
    • short-acting oral beta-agonists within 12 hours of Visit 1
    • use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
    • use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
    • use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 4 hours of Visit 1
    • use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
    • long-term oxygen therapy prescribed for >12 hours per day
    • regular use of nebulized short-acting bronchodilators
    • participation in acute phase of pulmonary rehabilitation program
    • known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
    • anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
    • previous exposure to UMEC, VI, UMEC/VI or the fluticasone furoate/VI combination

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-24-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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