A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma

NCT ID: NCT02753712

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2017-08-14

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).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

fluticasone/vilanterol DPI (Relvar Ellipta DPI)

Inhalation powder. 92/22µg, I inhalation od

Group Type: ACTIVE_COMPARATOR

Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)

Intervention Type: DRUG

Fluticasone/formoterol BAI

Pressurised suspension for inhalation 125/5µg, 2 inhalations bid

Group Type: EXPERIMENTAL

Fluticasone/Formoterol BAI

Intervention Type: DRUG

Interventions

Fluticasone/Formoterol BAI

Intervention Type: DRUG

Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

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.

Exclusion Criteria

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 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.

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Research Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Woolcock Institute of Medical Research

Glebe, New South Wales, Australia

Epworth Eastern Medical Centre

Box Hill, Victoria, Australia

Allergy immunology and Respiratory medicine, The Alfred Hospital

Melbourne, Victoria, Australia

The New Zealand Respiratory and Sleep Institute

Greenlane, Auckland, New Zealand

Otago Respiratory Research Unit

Dunedin, , New Zealand

INSPIRO, s.r.o. Ambulancia pneumológie a ftizeológie

Humenné, , Slovakia

DAMIZA, s.r.o. Ambulancia pneumológie a ftizeológie

Námestovo, , Slovakia

Poliklinika ADUS, Pľúcna ambulancia

Poprad, , Slovakia

PULMO, s.r.o

Prešov, , Slovakia

Pľúcna ambulancia Hrebenár, s.r.o.

Spišská Nová Ves, , Slovakia

ANA JJ, s.r.o, Ambulancia klinickej imunológie a alergológie

Topoľčany, , Slovakia

Skane University Hospital

Lund, , Sweden

Respiratory Biomedical Research Unit, Glenfield Hospital

Leicester, Leicestershire, United Kingdom

Bradford Teaching Hospital

Bradford, , United Kingdom

Royal Brompton and Harefield Foundation Trust

London, , United Kingdom

University Hospital of South Manchester

Manchester, , United Kingdom

Countries

Australia; New Zealand; Slovakia; Sweden; United Kingdom

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/search?query=KFL3502

Link to Eu CT Register

Other Identifiers

2015-000801-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KFL3502

Identifier Type: -

Identifier Source: org_study_id