Last updated: 11/07/2018 11:16:59
Population Meta-Pharmacokinetic Analysis of umeclidinium bromide/vilanterol from two Phase III studies (DB2113361, DB2113373) in Adults with Chronic Pulmonary Obstructive Disease (COPD)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Population Meta-Pharmacokinetic Analysis of umeclidinium bromide/vilanterol from two Phase III studies (DB2113361, DB2113373) in Adults with Chronic Pulmonary Obstructive Disease (COPD)
Trial description: A population PK model, including influential covariates, will be developed in order to describe the data. The covariates of interest include age, race, gender, weight, body mass index, concurrent medications (use of inhaled corticosteroids, cytochrome P450 inhibitors, Pgp inhibitors), baseline FEV1, reversibility to albuterol/salbutamol and responsiveness to ipratropium smoking status, and creatinine clearance.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Cmax
Timeframe: 24 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: VI 25mcg
Drug: UMEC/VI 62.5/25
Drug: UMEC/VI 125/25
Drug: UMEC 125mcg
Drug: UMEC 62.5mcg
Enrollment:
3029
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Goyal N, Beerahee M, Kalberg C, Church A, Kilbride S, Mehta R. Population pharmacokinetics of inhaled umeclidinium and vilanterol in patients with COPD. Clin Pharmacokinet. 2014;53(7):637-48.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
July 2012 to August 2012
Type
Observational
Phase
2/3
Participation criteria
Sex
Female & Male
Age
Not applicable
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-09-08
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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