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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02753712




Registration number
NCT02753712
Ethics application status
Date submitted
11/04/2016
Date registered
28/04/2016
Date last updated
23/10/2018

Titles & IDs
Public title
A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma
Scientific 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
Secondary ID [1] 0 0
2015-000801-38
Secondary ID [2] 0 0
KFL3502
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fluticasone/Formoterol BAI
Treatment: Drugs - Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)

Active Comparator: fluticasone/vilanterol DPI (Relvar Ellipta DPI) - Inhalation powder. 92/22µg, I inhalation od

Experimental: Fluticasone/formoterol BAI - Pressurised suspension for inhalation 125/5µg, 2 inhalations bid


Treatment: Drugs: Fluticasone/Formoterol BAI


Treatment: Drugs: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measuring peripheral airway resistance (R5-R20)
Timepoint [1] 0 0
From baseline to week 8
Secondary outcome [1] 0 0
measure ventilation heterogeneity (using Functional Respiratory Imaging)
Timepoint [1] 0 0
From baseline to week 9
Secondary outcome [2] 0 0
Measuring distal airway volume and resistance (using impulse oscillometry)
Timepoint [2] 0 0
From baseline to week 8 and 9
Secondary outcome [3] 0 0
Evaluate asthma control (using ACQ-6) )
Timepoint [3] 0 0
From baseline to week 4 and 8
Secondary outcome [4] 0 0
Evaluate health status (using AQLQ)
Timepoint [4] 0 0
From baseline to week 4 and 8

Eligibility
Key inclusion criteria
Inclusion Criteria for subjects on Seretide Accuhaler 250/50 µg at screening:

1. Male and female subjects =18 years old.

2. Adequate contraception

3. Documented clinical history of asthma for =6 months prior to screening visit

4. Using Seretide Accuhaler at a stable dose of 250/50 µg BID at screening for = 8 weeks.

5. uncontrolled asthma as defined by Asthma Control Questionnaire (ACQ-6) score = 1.0

6. R5-R20 = 0.10 kPa/L/s as measured on impulse oscillometry during the screening visit.

7. Historical evidence (within 24 months) of eosinophilic airways disease evidenced by
sputum eosinophil count = 3% and/or FeNO 35 ppb.

Inclusion criteria for subjects on equivalent /higher dose or other ICS-LABAs or higher
dose of Seretide at screening:

1. Male and female subjects =18 years old.

2. Adequate contraception

3. Documented clinical history of asthma for =6 months prior to screening visit

4. R5-R20 =0.07 kPa/L/s as measured on impulse oscillometry during the screening visit.

- 5. Historical evidence (within past 24 months) of eosinophilic airways disease,
evidenced by sputum eosinophil count =3% and/or FeNo =35 ppb.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for all subjects:

1. Any severe chronic respiratory disease other than asthma.

2. 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.)

3. Current smoking history within 12 months prior to the screening visit

4. Near fatal or life-threatening (including intubation) asthma within the past year.

5. Known history of systemic (injectable or oral) corticosteroid medication within 1
month of visit 1.

6. 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.

7. In the investigator's opinion a clinically significant upper or lower respiratory
infection within 4 weeks prior to visit 1.

8. Current evidence or known history of alcohol and/or substance abuse within 12 months
prior to the screening visit.

9. Subject has taken ß-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.

10. Current use of bronchodilators / anti-inflammatory agents other than those specified
in the protocol.

11. Known or suspected sensitivity to study drug or excipients.

12. Participation in a clinical drug study within 30 days of the screening visit.

13. Current participation in a clinical study.

Exclusion Criteria for subset of subjects undergoing OR-MRI and HD-CT

1. 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.

2. Inability to stay in the supine position for the duration of the scanning procedure

3. Obesity (body weight >140kg).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/08/2017
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Woolcock Institute of Medical Research - Glebe
Recruitment hospital [2] 0 0
Epworth Eastern Medical Centre - Box Hill
Recruitment hospital [3] 0 0
Allergy immunology and Respiratory medicine, The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
NSW 2037 - Glebe
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin
Country [3] 0 0
Slovakia
State/province [3] 0 0
Humenné
Country [4] 0 0
Slovakia
State/province [4] 0 0
Námestovo
Country [5] 0 0
Slovakia
State/province [5] 0 0
Poprad
Country [6] 0 0
Slovakia
State/province [6] 0 0
Prešov
Country [7] 0 0
Slovakia
State/province [7] 0 0
Spišská Nová Ves
Country [8] 0 0
Slovakia
State/province [8] 0 0
Topolcany
Country [9] 0 0
Sweden
State/province [9] 0 0
Lund
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Leicestershire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Bradford
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mundipharma Research Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02753712
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02753712