A study to compare the effects of fluticasone / formoterol BAI against Relvar® Ellipta® dry powder inhaler (DPI) on asthma

Phase 1

• Conditions: Asthma Bronciale; MedDRA version: 18.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 18.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 18.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000801-38-SE
• Lead Sponsor: Mundipharma Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Participants to be included in the study are those who meet all of the following criteria:

Inclusion criteria (for participants on Seretide Accuhaler 250/50 µg at screening):
1. Male and female participants =18 years old.
2. Female participants less than one year post-menopausal must have a negative urine
pregnancy test recorded at the screening visit prior to the first dose of study
medication, be non-lactating, and willing to use adequate and highly effective
methods of contraception throughout the study. A highly effective method of birth
control is defined as those which result in a low failure rate (i.e., less than
1% per year) when used consistently and correctly such as sterilisation,
implants, injectables, combined oral contraceptives, some IUDs (Intrauterine
Device, hormonal), true sexual abstinence, where this is in line with the
preferred and usual lifestyle of the participant, or vasectomised partner.
Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation
methods), declaration of abstinence for duration of study, and withdrawal are not
acceptable methods of 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 past 24 months) of eosinophilic airways disease,
evidenced by sputum eosinophil count = 3% and/or FeNO = 35 ppb.
8. Good compliance with current asthma medication(s) in the Investigators opinion.
9. Willing and able to substitute pre-study prescribed inhaled asthma medication for
the entire duration of the study.
10. Willing and able to attend all study visits.
11. Written informed consent obtained.

Inclusion criteria (for participants on equivalent /higher dose or other ICS-LABAs or higher dose of Seretide at screening):
1. Male and females participants =18 years old.
2. Female participants less than one year post-menopausal must have a negative urine
pregnancy test recorded at the screening visit prior to the first dose of study
medication, be non-lactating, and willing to use adequate and highly effective
methods of contraception throughout the study. A highly effective method of birth
control is defined as those which result in a low failure rate (i.e., less than
1% per year) when used consistently and correctly such as sterilisation,
implants, injectables, combined oral contraceptives, some IUDs (Intrauterine
Device, hormonal), true sexual abstinence where this is in line with the
preferred and usual lifestyle of the participant, or vasectomised partner. Note:
Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods),
declaration of abstinence for duration of study, and withdrawal are not
acceptable methods of 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.
6. Good compliance with current asthma me

Exclusion Criteria

Participants to be excluded from the study are those who meet any of the following criteria:
1. Any severe chronic respiratory disease other than asthma.
2. Participant 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 participant 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. Participant 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 participants undergoing OE-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 that 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 >140 kg).

Randomisation Criteria required following Run-in
1. R5-R20 = 0.10 kPa/L/s
2. ACQ-6 score =1.0

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified