AsthmaPhase 4NCT03898466
Effect of Fluticasone Furoate on Methacholine Challenge
A Phase 4 study testing Fluticasone furoate in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2018to 1 Apr 2019
- 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
- forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted
- methacholine PD20 less than or equal to 400mcg
- no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start
Who cannot join
- regular use of inhaled corticosteroid within 4 weeks of study start
- poorly controlled asthma
- current smoker or ex smoker with greater than 10 pack year history
- pregnancy or breast-feeding
- health concern/condition that would preclude participation for safety reasons
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics
The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.
- Conditions
- Asthma
- Being tested
- Fluticasone furoate, Matching placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoateDrug
Also called Arnuity
Inhaled corticosteroid
Matching placeboOther
Placebo inhaler
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Furoate | Experimental | Daily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.
The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints Receives: Drug: Fluticasone furoate |
| Matching Placebo | Placebo comparator | Daily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.
The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints Receives: Other: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
Change from baseline in airway response to inhaled methacholine following daily dosing with fluticasone furoate or placebo
Measured: 24 hours post dose, 72 hours post dose and 168 hours post dose
Secondary outcomes (2)
Fractional exhaled nitric oxide (FeNO)
Change from baseline on levels of fractional exhaled nitric oxide
Measured: 168 hours
Sputum eosinophils
Assessment of induced sputum differential cell counts
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start30 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
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
- 14 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898466
- Sponsor's protocol ID
- Bio ID 366
- Status last verified
- Dec 2019
- First submitted
- 29 Mar 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Okonkwo CS, Davis BE, Blais CM, Cockcroft DW. Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2019 Sep;156:53-57. doi: 10.1016/j.rmed.2019.08.007. Epub 2019 Aug 13.
PubMed 31434037
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics
- ClinicalTrials.gov ID
- NCT03898466
- Acronym / sponsor ID
- Bio ID 366
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 2 Apr 2019 (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 determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Furoate | Experimental | Drug: Fluticasone furoateDaily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours. The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints |
| Matching Placebo | Placebo comparator | Other: Matching placeboDaily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours. The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted
- methacholine PD20 less than or equal to 400mcg
- no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start
Key exclusion criteria (5 listed)
- regular use of inhaled corticosteroid within 4 weeks of study start
- poorly controlled asthma
- current smoker or ex smoker with greater than 10 pack year history
- pregnancy or breast-feeding
- health concern/condition that would preclude participation for safety reasons
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 |
|---|---|---|
| Fluticasone furoateAlso: ArnuityInhaled corticosteroid | Drug | Fluticasone Furoate |
| Matching placeboPlacebo inhaler | Other | Matching Placebo |
Primary outcome
Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
Time frame: 24 hours post dose, 72 hours post dose and 168 hours post dose
Change from baseline in airway response to inhaled methacholine following daily dosing with fluticasone furoate or placebo
2 secondary outcomes
Fractional exhaled nitric oxide (FeNO)
Time frame: 168 hours
Sputum eosinophils
Time frame: Baseline
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 10 Dec 2019.
- Derived from this study: PubMed 31434037Okonkwo CS, Davis BE, Blais CM, Cockcroft DW. Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2019 Sep;156:53-57. doi: 10.1016/j.rmed.2019.08.007. Epub 2019 Aug 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 3 inclusion and 5 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 10 Dec 2019. 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?
Methacholine provocation dose causing a 20% fall in FEV1 (PD20) (time frame: 24 hours post dose, 72 hours post dose and 168 hours post dose). 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 NCT03898466, 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 10 Dec 2019.