An Open Label Oxygen Enhanced Imaging Biomarker Study in Moderate to Severe Asthma.

An Open Label Oxygen Enhanced Imaging Biomarker Study to Assess the Role of Fluticasone/Formoterol upon Airway Function in Moderate to Severe Persistent Asthma. - An Open Label Oxygen Enhanced Imaging Biomarker Asthma Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000172-98-GB

Enrollment

Registered

2019-06-17

Start date

2015-03-24

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: flutiform Product Name: flutiform Pharmaceutical Form: Inhalation vapour INN or Proposed INN: fluticasone propionate Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Asthma Patients • Asthma • Aged 18-70 years • GINA treatment steps 3/4 • Physician diagnosis and one or more of the following (i) PC20 = 8 mg/ml, (ii) bronchodilator reversibility FEV1 > 12%/200mls, (iii) Peak flow variability of = 20% over 2 weeks • Post-bronchodilator FEV1% predicted of = 60% and an FEV1/FVC ratio of =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Asthma Patients * Exacerbation within the previous 6 weeks requiring oral steroids * Concurrent leukotriene receptor antagonist or theophylline * Non reversible active lung disease e.g. bronchiectasis * Current smoker/ = 10 pack year smoking history * Use of beta blocker, tricyclic antidepressant, mono amine oxidase inhibitor, quinidine type anti arrhythmic, or potent CYP3A4 inhibitors within the past week * Unable to provide informed consent * Pregnancy or lactating at the time of consent (or) if identified as pregnant by a pregnancy test during the first study visit. * History of poor treatment adherence * Claustrophobia * Metallic implants/screen failure on MRI safety questionnaire * 70 years Exclusion Criteria for Healthy Volunteers Non reversible active lung disease e.g. bronchiectasis Current smoker/ = 10 pack year smoking history Use of beta blocker, tricyclic antidepressant, mono amine oxidase inhibitor, quinidine type anti arrhythmic, or potent CYP3A4 inhibitors within the past week Unable to provide informed consent Pregnancy or lactating at the time of consent (or) if identified as pregnant by a pregnancy test during the first study visit. Claustrophobia Metallic implants/screen failure on MRI safety questionnaire 70 years

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 30 minutes post inhlation of Flutiform.; Main Objective: Inhaled Fluticasone/Formoterol improves both large and small airway function in moderate to severe persistent asthma. The primary objective of this study is to demonstrate a statistically significant change in both OE-MRI imaging biomarkers [oxygen exponential washout time (ôdown) and major airway ventilation (Tvent) time] using dynamic OE-MRI in moderate-to-severe asthmatics, within 30 minutes of administration of two observed inhalations via spacer of Fluticasone/Formoterol [250/10]. ; Secondary Objective: • To demonstrate significant improvement of conventional lung physiological measurements (LCI, Scond and Sacin) within 60 minutes of administration of Fluticasone/Formoterol. • To investigate alterations in other OE-MRI imaging markers including ventilated fraction, exponential wash-in time (ôup), maximum ÄPO2, V/Q. • To investigate degree of regional lung variation in response to Fluticasone/Formoterol on OE-MRI. ;Primary end point(s): The primary objective of this study is to demonstrate a statistically significant change in both oxygen exponential washout time (ôdown) and major airway ventilation (Tvent) time using dynamic OE-MRI in moderate-to-severe asthmatics (GINA 3-4), within 30 minutes of administration of two observed inhalations via spacer of Fluticasone/Formoterol [250/10].	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 30 minutes post inhlation of Flutiform.; Main Objective: Inhaled Fluticasone/Formoterol improves both large and small airway function in moderate to severe persistent asthma. The primary objective of this study is to demonstrate a statistically significant change in both OE-MRI imaging biomarkers [oxygen exponential washout time (ôdown) and major airway ventilation (Tvent) time] using dynamic OE-MRI in moderate-to-severe asthmatics, within 30 minutes of administration of two observed inhalations via spacer of Fluticasone/Formoterol [250/10]. ; Secondary Objective: • To demonstrate significant improvement of conventional lung physiological measurements (LCI, Scond and Sacin) within 60 minutes of administration of Fluticasone/Formoterol. • To investigate alterations in other OE-MRI imaging markers including ventilated fraction, exponential wash-in time (ôup), maximum ÄPO2, V/Q. • To investigate degree of regional lung variation in response to Fluticasone/Formoterol on OE-MRI. ;Primary end point(s): The primary objective of this study is to demonstrate a statistically significant change in both oxygen exponential washout time (ôdown) and major airway ventilation (Tvent) time using dynamic OE-MRI in moderate-to-severe asthmatics (GINA 3-4), within 30 minutes of administration of two observed inhalations via spacer of Fluticasone/Formoterol [250/10].

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 30 minutes post inhlation of Flutiform.; Secondary end point(s): • To demonstrate significant improvement of conventional SF6 multiple breath washout physiological measurements (LCI, Scond and Sacin) within 30 minutes of administration of Fluticasone/Formoterol. • To investigate alterations in other OE-MRI parameters including ventilated fraction, exponential wash-in time (tup), maximum ?PO2, V/Q (see section 7.9). • To investigate degree of spatial heterogeneity in response to Fluticasone/Formoterol on OE-MRI	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 30 minutes post inhlation of Flutiform.; Secondary end point(s): • To demonstrate significant improvement of conventional SF6 multiple breath washout physiological measurements (LCI, Scond and Sacin) within 30 minutes of administration of Fluticasone/Formoterol. • To investigate alterations in other OE-MRI parameters including ventilated fraction, exponential wash-in time (tup), maximum ?PO2, V/Q (see section 7.9). • To investigate degree of spatial heterogeneity in response to Fluticasone/Formoterol on OE-MRI

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Countries

United Kingdom

Contacts

Public ContactSalman Siddiqui

University Hospitals of Leicester NHS Trust

ss338@le.ac.uk01162586841

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026