AsthmaPhase 4NCT03315000
Effect of Vilanterol on Methacholine Challenge Results
A Phase 4 study testing Vilanterol and Fluticasone Furoate and Fluticasone Furoate in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Vilanterol and Fluticasone Furoate and Fluticasone Furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2017to 1 May 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women aged 18 or older
- stable mild-to-moderate asthma
- baseline methacholine PC20 less than or equal to 8mg/mL
- FEV1 greater than or equal to 65% of predicted
Who cannot join
- Use of long-acting anticholinergic or long-acting beta2 agonist within 30 days of study
- pregnant or nursing
- diabetes
- hypokalemia
- cardiovascular, prostate, kidney, or urinary retention problems
- lactose-intolerant
Show all 9Show fewer
- allergy-induced asthma symptoms or upper respiratory tract infection within four weeks of study
- current smokers
- past smokers with smoking history >10 pack years
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: The Effect of Vilanterol Against Methacholine-induced Bronchoconstriction in Mild Asthmatics
The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.
Read the detailed description
This will be a double-blind, three-way crossover study comparing combination vilanterol+fluticasone with fluticasone monotherapy and a placebo (vilanterol is not available as a monotherapy). The order in which the treatments are given will be randomized and each treatment will be separated by a minimum one-week washout. Fifteen asthmatic participants will be recruited from the local community. Methacholine challenge testing (MCT) with the two-minute tidal breathing protocol will be used to quantify the bronchoprotective effects (if any) of each treatment against methacholine-induced bronchoconstriction.
Each participant will undergo a total of nine methacholine challenges. After a baseline methacholine challenge, the randomized treatment (identity unknown to investigator or participant) will be administered through an Ellipta® (multi-dose dry powder inhaler). Thirty minutes following treatment administration, a second methacholine challenge will be performed. At 24 hours post-treatment, each participant must re-visit the lab for one methacholine challenge. The same process will be followed for each treatment.
- Conditions
- Asthma
- Being tested
- Vilanterol and Fluticasone Furoate, Fluticasone Furoate, Placebos
- Keywords
- methacholine, airway hyperresponsiveness
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilanterol and Fluticasone FuroateDrug
Also called Breo
Same as vilanterol arm description
Fluticasone FuroateDrug
Also called Arnuity
Same as fluticasone arm description
PlacebosDrug
Also called lactose powder
Same as placebo arm description
| Study group | Role | What they receive |
|---|---|---|
| Vilanterol | Experimental | Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler Receives: Drug: Vilanterol and Fluticasone Furoate |
| Fluticasone | Experimental | Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler Receives: Drug: Fluticasone Furoate |
| Placebo | Placebo comparator | Lactose powder inhaled through Ellipta® inhaler Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
Measured: baseline versus 30 min post-treatment
Secondary outcomes (1)
Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
Measured: baseline versus 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start13 Oct 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315000
- Sponsor's protocol ID
- VIL-2017
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Journal Publication
Publications
Westbury GLM, Blais CM, Davis BE, Cockcroft DW. Bronchoprotective effect of vilanterol against methacholine-induced bronchoconstriction in mild asthmatics: A randomized three-way crossover study. Ann Allergy Asthma Immunol. 2018 Sep;121(3):328-332. doi: 10.1016/j.anai.2018.07.005. Epub 2018 Jul 12.
PubMed 30017826
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vilanterol Against Methacholine-induced Bronchoconstriction in Mild Asthmatics
- ClinicalTrials.gov ID
- NCT03315000
- Acronym / sponsor ID
- VIL-2017
- Conditions
- Asthma
- Keywords
- methacholine, airway hyperresponsiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Oct 2017 (actual)
- 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 assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.
Detailed description
This will be a double-blind, three-way crossover study comparing combination vilanterol+fluticasone with fluticasone monotherapy and a placebo (vilanterol is not available as a monotherapy). The order in which the treatments are given will be randomized and each treatment will be separated by a minimum one-week washout. Fifteen asthmatic participants will be recruited from the local community. Methacholine challenge testing (MCT) with the two-minute tidal breathing protocol will be used to quantify the bronchoprotective effects (if any) of each treatment against methacholine-induced bronchoconstriction.
Each participant will undergo a total of nine methacholine challenges. After a baseline methacholine challenge, the randomized treatment (identity unknown to investigator or participant) will be administered through an Ellipta® (multi-dose dry powder inhaler). Thirty minutes following treatment administration, a second methacholine challenge will be performed. At 24 hours post-treatment, each participant must re-visit the lab for one methacholine challenge. The same process will be followed for each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vilanterol | Experimental | Drug: Vilanterol and Fluticasone FuroateVilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler |
| Fluticasone | Experimental | Drug: Fluticasone FuroateFluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler |
| Placebo | Placebo comparator | Drug: PlacebosLactose powder inhaled through Ellipta® inhaler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women aged 18 or older
- stable mild-to-moderate asthma
- baseline methacholine PC20 less than or equal to 8mg/mL
- FEV1 greater than or equal to 65% of predicted
Key exclusion criteria (9 listed)
- Use of long-acting anticholinergic or long-acting beta2 agonist within 30 days of study
- pregnant or nursing
- diabetes
- hypokalemia
- cardiovascular, prostate, kidney, or urinary retention problems
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 |
|---|---|---|
| Vilanterol and Fluticasone FuroateAlso: BreoSame as vilanterol arm description | Drug | Vilanterol |
| Fluticasone FuroateAlso: ArnuitySame as fluticasone arm description | Drug | Fluticasone |
| PlacebosAlso: lactose powderSame as placebo arm description | Drug | Placebo |
Primary outcome
Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment
Time frame: baseline versus 30 min post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
1 secondary outcome
Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment
Time frame: baseline versus 24 hours post-treatment
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 11 Oct 2018.
- Derived from this study: PubMed 30017826Westbury GLM, Blais CM, Davis BE, Cockcroft DW. Bronchoprotective effect of vilanterol against methacholine-induced bronchoconstriction in mild asthmatics: A randomized three-way crossover study. Ann Allergy Asthma Immunol. 2018 Sep;121(3):328-332. doi: 10.1016/j.anai.2018.07.005. Epub 2018 Jul 12.
- Individual participant dataSharing planned: Yes. Journal Publication
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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.
Don Cockcroft, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vilanterol and Fluticasone Furoate and Fluticasone Furoate in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
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 4 inclusion and 9 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 11 Oct 2018. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 methacholine PC20 (bronchoprotection) at 30 min post-treatment (time frame: baseline versus 30 min post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315000, which also lists 1 linked publication.
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 11 Oct 2018.