AsthmaPhase 1NCT01837316
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
A Phase 1 study testing FF/VI 100/25 mcg in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- FF/VI 100/25 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNew Zealand
- Study dates
- 21 Oct 2013to 8 Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Asthma
- Being tested
- FF/VI 100/25 mcg, Placebo
- Keywords
- pharmacodynamics, FF/VI, asthma, duration of action
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FF/VI 100/25 mcgDrug
First strip: Fluticasone furoate inhalation powder blended with lactose, 100 mcg per blister
PlaceboDrug
First strip: Inhalation powder of lactose
| Study group | Role | What they receive |
|---|---|---|
| FF/VI | Experimental | A single dose inhalation of FF/VI 100/25 mcg in the morning Receives: Drug: FF/VI 100/25 mcg |
| Placebo | Placebo comparator | A single dose inhalation of matching placebo in the morning Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in FEV1 at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and 72 hours post dose.
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.
Measured: Baseline (pre dose) and 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and 72 hours post dose in each treatment period
Secondary outcomes (1)
Time to onset of bronchodilator effect of FF/VI 100/25 mcg
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
Measured: Baseline, 15, 30 minutes, 1, 2, 4 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study start21 Oct 2013
- Primary completion8 Aug 2014
- Study completion8 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837316
- Sponsor's protocol ID
- 116592
- Status last verified
- May 2017
- First submitted
- 18 Apr 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01837316
- Acronym / sponsor ID
- 116592
- Conditions
- Asthma
- Keywords
- pharmacodynamics, FF/VI, asthma, duration of action
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 8 Aug 2014 (actual)
- Study completion
- 8 Aug 2014 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FF/VI | Experimental | Drug: FF/VI 100/25 mcgA single dose inhalation of FF/VI 100/25 mcg in the morning |
| Placebo | Placebo comparator | Drug: PlaceboA single dose inhalation of matching placebo in the morning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FF/VI 100/25 mcgFirst strip: Fluticasone furoate inhalation powder blended with lactose, 100 mcg per blister | Drug | FF/VI |
| PlaceboFirst strip: Inhalation powder of lactose | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 116592 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FF/VI 100/25 mcg in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.