AsthmaPhase 3NCT02753712
A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma
A Phase 3 study testing Fluticasone/Formoterol BAI and Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) in people with Asthma, run by Mundipharma Research Limited at 16 sites in 5 countries.
Trial summary
The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI). 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/Formoterol BAI and Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 15 Jun 2016to 14 Aug 2017
- Phase
- Phase 3
- 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
None listed.
Who cannot join
- Any severe chronic respiratory disease other than asthma.
- Subject has a smoking history ≥10 "pack years" (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.)
- Current smoking history within 12 months prior to the screening visit
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Known history of systemic (injectable or oral) corticosteroid medication within 1 month of visit 1.
- Evidence of a clinically unstable disease as determined by medical history or physical examination that, in the investigator's opinion, precludes entry into the study. 'Clinically unstable' is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
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- In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to visit 1.
- Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the screening visit.
- Subject has taken β-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to screening visit.
- Current use of bronchodilators / anti-inflammatory agents other than those specified in the protocol.
- Known or suspected sensitivity to study drug or excipients.
- Participation in a clinical drug study within 30 days of the screening visit.
- Current participation in a clinical study.
- Exclusion Criteria for subset of subjects undergoing OR-MRI and HD-CT
- Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes, but is not limited to: presence of non-MRI compatible artificial heart valves, hydrocephalus shunts, intracranial aneurysm clips, joint replacements or metal implants, pacemakers or other cardiac rhythm management devices, claustrophobia, history of metal in the eye, presence of shrapnel from a war injury, callipers or braces, dentures, dental plates or hearing aids that include metal and cannot be removed, history of epilepsy or black-outs, ear implants, piercings cannot be removed, intrauterine contraceptive device or coil.
- Inability to stay in the supine position for the duration of the scanning procedure
- Obesity (body weight >140kg).
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Slovakia6 sites
INSPIRO, s.r.o. Ambulancia pneumológie a ftizeológie
Humenné, 066 01
DAMIZA, s.r.o. Ambulancia pneumológie a ftizeológie
Námestovo, 029 01
Poliklinika ADUS, Pľúcna ambulancia
Poprad, 05801
PULMO, s.r.o
Prešov, 080 01
Pľúcna ambulancia Hrebenár, s.r.o.
Spišská Nová Ves, 052 01
ANA JJ, s.r.o, Ambulancia klinickej imunológie a alergológie
Topoľčany, 955 01
United Kingdom4 sites
Bradford Teaching Hospital
Bradford, BD9 6RJ
Respiratory Biomedical Research Unit, Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
Royal Brompton and Harefield Foundation Trust
London, SW3 6HP
University Hospital of South Manchester
Manchester, M23 9QZ
Australia3 sites
Epworth Eastern Medical Centre
Box Hill, Victoria, 3128
The Woolcock Institute of Medical Research
Glebe, New South Wales, NSW 2037
Allergy immunology and Respiratory medicine, The Alfred Hospital
Melbourne, Victoria, 3004
New Zealand2 sites
Otago Respiratory Research Unit
Dunedin, 9016
The New Zealand Respiratory and Sleep Institute
Greenlane, Auckland, 1051
About this study
Official title: A Two-arm, Randomised, Assessor-blind, Parallel Group Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) and Relvar® Ellipta® DPI on Ventilation Heterogeneity in Subjects With Partially Controlled or Uncontrolled Asthma
The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).
- Conditions
- Asthma
- Being tested
- Fluticasone/Formoterol BAI, Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
- Keywords
- Small airway disease, asthma
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone/Formoterol BAIDrug
Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)Drug
| Study group | Role | What they receive |
|---|---|---|
| fluticasone/vilanterol DPI (Relvar Ellipta DPI) | Active comparator | Inhalation powder. 92/22µg, I inhalation od Receives: Drug: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) |
| Fluticasone/formoterol BAI | Experimental | Pressurised suspension for inhalation 125/5µg, 2 inhalations bid Receives: Drug: Fluticasone/Formoterol BAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring peripheral airway resistance (R5-R20)
Measuring peripheral airway resistance (R5-R20)
Measured: From baseline to week 8
Secondary outcomes (4)
measure ventilation heterogeneity (using Functional Respiratory Imaging)
measures of ventilation heterogeneity
Measured: From baseline to week 9
Measuring distal airway volume and resistance (using impulse oscillometry)
Measuring distal airway volume and resistance (using Functional Respiratory Imaging (FRI)
Measured: From baseline to week 8 and 9
Evaluate asthma control (using ACQ-6) )
Evaluate asthma control (using ACQ-6) )
Measured: From baseline to week 4 and 8
Evaluate health status (using AQLQ)
Evaluate health status (using AQLQ)
Measured: From baseline to week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start15 Jun 2016
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753712
- Sponsor's protocol ID
- KFL3502
- Other IDs
- 2015-000801-38, 2015
- Status last verified
- Oct 2018
- First submitted
- 11 Apr 2016
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Randomised, Assessor-blind, Parallel Group Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) and Relvar® Ellipta® DPI on Ventilation Heterogeneity in Subjects With Partially Controlled or Uncontrolled Asthma
- ClinicalTrials.gov ID
- NCT02753712
- Acronym / sponsor ID
- KFL3502
- Conditions
- Asthma
- Keywords
- Small airway disease, asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 28 Apr 2016 (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 purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluticasone/vilanterol DPI (Relvar Ellipta DPI) | Active comparator | Drug: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)Inhalation powder. 92/22µg, I inhalation od |
| Fluticasone/formoterol BAI | Experimental | Drug: Fluticasone/Formoterol BAIPressurised suspension for inhalation 125/5µg, 2 inhalations bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Any severe chronic respiratory disease other than asthma.
- Subject has a smoking history ≥10 "pack years" (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.)
- Current smoking history within 12 months prior to the screening visit
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Known history of systemic (injectable or oral) corticosteroid medication within 1 month of visit 1.
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/Formoterol BAI | Drug | Fluticasone/formoterol BAI |
| Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) | Drug | fluticasone/vilanterol DPI (Relvar Ellipta DPI) |
Primary outcome
Measuring peripheral airway resistance (R5-R20)
Time frame: From baseline to week 8
Measuring peripheral airway resistance (R5-R20)
4 secondary outcomes
measure ventilation heterogeneity (using Functional Respiratory Imaging)
Time frame: From baseline to week 9
Measuring distal airway volume and resistance (using impulse oscillometry)
Time frame: From baseline to week 8 and 9
Evaluate asthma control (using ACQ-6) )
Time frame: From baseline to week 4 and 8
Evaluate health status (using AQLQ)
Time frame: From baseline to week 4 and 8
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 23 Oct 2018.
- Link to Eu CT RegisterLink provided by the sponsor.
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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.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone/Formoterol BAI and Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) in people with Asthma, run by Mundipharma Research Limited at 16 sites in 5 countries.
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 0 inclusion and 17 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 23 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 16 sites in Slovakia, United Kingdom, Australia, New Zealand, Sweden. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Measuring peripheral airway resistance (R5-R20) (time frame: From baseline to week 8). 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 23 Oct 2018.