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

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ClinicalTrials.gov Identifier: NCT02753712
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited

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).

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone/Formoterol BAI Drug: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : August 14, 2017


Arm Intervention/treatment
Active Comparator: fluticasone/vilanterol DPI (Relvar Ellipta DPI)
Inhalation powder. 92/22µg, I inhalation od
Drug: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
Experimental: Fluticasone/formoterol BAI
Pressurised suspension for inhalation 125/5µg, 2 inhalations bid
Drug: Fluticasone/Formoterol BAI



Primary Outcome Measures :
  1. Measuring peripheral airway resistance (R5-R20) [ Time Frame: From baseline to week 8 ]
    Measuring peripheral airway resistance (R5-R20)


Secondary Outcome Measures :
  1. measure ventilation heterogeneity (using Functional Respiratory Imaging) [ Time Frame: From baseline to week 9 ]
    measures of ventilation heterogeneity

  2. Measuring distal airway volume and resistance (using impulse oscillometry) [ Time Frame: From baseline to week 8 and 9 ]
    Measuring distal airway volume and resistance (using Functional Respiratory Imaging (FRI)

  3. Evaluate asthma control (using ACQ-6) ) [ Time Frame: From baseline to week 4 and 8 ]
    Evaluate asthma control (using ACQ-6) )

  4. Evaluate health status (using AQLQ) [ Time Frame: From baseline to week 4 and 8 ]
    Evaluate health status (using AQLQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753712


Locations
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Australia, New South Wales
The Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, NSW 2037
Australia, Victoria
Epworth Eastern Medical Centre
Box Hill, Victoria, Australia, 3128
Allergy immunology and Respiratory medicine, The Alfred Hospital
Melbourne, Victoria, Australia, 3004
New Zealand
The New Zealand Respiratory and Sleep Institute
Greenlane, Auckland, New Zealand, 1051
Otago Respiratory Research Unit
Dunedin, New Zealand, 9016
Slovakia
INSPIRO, s.r.o. Ambulancia pneumológie a ftizeológie
Humenné, Slovakia, 066 01
DAMIZA, s.r.o. Ambulancia pneumológie a ftizeológie
Námestovo, Slovakia, 029 01
Poliklinika ADUS, Pľúcna ambulancia
Poprad, Slovakia, 05801
PULMO, s.r.o
Prešov, Slovakia, 080 01
Pľúcna ambulancia Hrebenár, s.r.o.
Spišská Nová Ves, Slovakia, 052 01
ANA JJ, s.r.o, Ambulancia klinickej imunológie a alergológie
Topoľčany, Slovakia, 955 01
Sweden
Skane University Hospital
Lund, Sweden, 221 85
United Kingdom
Respiratory Biomedical Research Unit, Glenfield Hospital
Leicester, Leicestershire, United Kingdom, LE3 9QP
Bradford Teaching Hospital
Bradford, United Kingdom, BD9 6RJ
Royal Brompton and Harefield Foundation Trust
London, United Kingdom, SW3 6HP
University Hospital of South Manchester
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Mundipharma Research Limited
Additional Information:
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Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT02753712    
Other Study ID Numbers: KFL3502
2015-000801-38 ( EudraCT Number )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Keywords provided by Mundipharma Research Limited:
Small airway disease
asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action