A Study to Compare Fluticasone /Formoterol Breath Actuated Inhaler (BAI) and Ultibro in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils

December 9, 2016 updated by: Mundipharma Research Limited

A Randomised, Single Blind, Cross-over Study to Compare a Fixed Dose Combination of Fluticasone Propionate / Formoterol Fumarate (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

The purpose of this study is to investigate whether fluticasone/formoterol Breath actuated inhaler is effective and well tolerated in the treatment of subjects with fixed airflow obstruction and elevated eosinophils.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study is designed to provide efficacy and safety data for the use of fluticasone/formoterol Breath actuated inhaler in subjects with the characteristics of fixed airflow obstruction and elevated eosinophils. These patients have typically been excluded from previous Flutiform pMDI asthma and chronic obstructive pulmonary disease (COPD) trials; for example in asthma studies, patients with a smoking history of 10 pack years or more have been excluded, conversely in COPD studies patients with any prior history of asthma have been excluded. It is expected that the data from this study will provide a greater understanding of the effects of fluticasone/formoterol in this patient population

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Košice, Slovakia, 040 01
        • JURMED, s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects aged ≥ 40 years at Screening visit.
  2. Adequate contraception:
  3. Diagnosis of fixed airflow obstruction with elevated eosinophils
  4. Subjects symptomatic at Visit 1 (CAT ≥10) despite currently receiving treatment with either LAMA or LABA monotherapy or LAMA + LABA as a combination inhaler or separate inhalers.
  5. Documented history of ≥ 1 moderate or severe respiratory disease exacerbations (requiring treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation) in the previous year.
  6. Willing and able to replace current therapy for obstructive lung disease with study medication.
  7. Able to demonstrate correct use of a BAI, Breezehaler and pMDI.

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 α1-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.
  11. Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
  12. Known or suspected history of drug or alcohol abuse in the last 2 years.
  13. Requiring treatment with any of the prohibited concomitant medications.
  14. Known or suspected hypersensitivity or contraindication to any of the study drugs or excipients.
  15. Received an investigational drug within 30 days of the Screening.
  16. Received a systemic corticosteroid within 30 days of the Screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fluticasone/formoterol BAI
To compare the efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.)
Drug: fluticasone propionate/formoterol fumarate breath actuated inhaler
Drug: Indacaterol maleate / glycopyrronium bromide capsules
Active Comparator: Ultibro Breezhaler
Ultibro Breezhaler 85/43 µg (1 puff o.d.)
Drug: fluticasone propionate/formoterol fumarate breath actuated inhaler
Drug: Indacaterol maleate / glycopyrronium bromide capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) versus Ultibro Breezhaler 85/43 µg (1 puff o.d.) in terms of the percentage of eosinophils in induced sputum
Time Frame: at Week 6 of each treatment
at Week 6 of each treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) versus Ultibro Breezhaler 85/43 µg (1 puff o.d.) in terms of the serum concentration of surfactant protein D (SPD)
Time Frame: at Week 6 of each treatment.
at Week 6 of each treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma Research Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFL3503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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