A randomised, single blind, cross-over study to compare a fixed dose combination of fluticasone propionate / formoterol fumarate (fluticasone /formoterol breath actuated inhaler (BAI)) with a fixed dose combination of indacaterol maleate / glycopyrronium bromide (Ultibro® Breezhaler) in subjects with fixed airflow obstruction and elevated eosinophils.

Mundipharma Research Limited0 sites130 target enrollmentDecember 28, 2015

Drugsflutiform® 125 microgram / 5 microgram per actuation pressurised inhalation, suspension Ultibro® Breezhaler 85 micrograms/43 micrograms, inhalation powder hard capsules

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Mundipharma Research Limited
Enrollment: 130
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 28, 2015

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Mundipharma Research Limited

Eligibility Criteria

Inclusion Criteria

•1\. Male or female subjects aged \= 40 years at Screening visit.
•2\. Adequate contraception:
•\- Female subjects of child bearing potential (less than 1 year post\-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non\-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra\-uterine devices, sexual abstinence, where this is line with the preferred and usual lifestyle of the subject 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).
•\- Male subjects with a partner of child\-bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study (as defined above).
•3\. Diagnosis of fixed airflow obstruction with elevated eosinophils /ACOS as evidenced by:
•\- Chronic respiratory symptoms e.g. wheezing, dyspnoea, especially exertional dyspnoea) for at least 6 months prior to Screening.
•\- Smoking history of \= 10 pack years (equivalent to, for example, 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years).
•\- Post\-bronchodilator FEV1 / FVC ratio \< 0\.7 and post bronchodilator FEV1 \>30 and \<\=60% predicted normal measured at visit 1 (GLI 2012\).
•\- Evidence of eosinophilic inflammation demonstrated by eosinophils in induced sputum of \=3% at Visit 1 (assessed at central laboratory) and Visit 3 (assessed at local laboratory).

Exclusion Criteria

•1\. Respiratory disease exacerbation between 4 weeks prior to screening and Visit 3 (Randomisation).
•2\. Previous treatment with ICS.
•3\. Documented evidence of a1\-antitrypsin deficiency.
•4\. Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
•5\. Use of long\-term oxygen therapy (LTOT) at least 12 hours daily or mechanical ventilation.
•6\. Chest X\-ray or CT scans performed prior to screening which reveal evidence of clinically significant abnormalities reflective of active disease not believed to be due to COPD.
•7\. Evidence of uncontrolled cardiovascular disease.
•8\. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
•9\. Current malignancy or a previous history of cancer which has been in remission for \< 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded).
•10\. Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non\-invasive positive pressure ventilation (NIPPV) device.