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Trial record 22 of 1645 for:    Slovakia

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

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ClinicalTrials.gov Identifier: NCT02693769
Recruitment Status : Terminated (Recruitment issues)
First Posted : February 29, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ACOS (Fixed Airflow Obstruction and Elevated Eosinophils) Drug: fluticasone propionate/formoterol fumarate breath actuated inhaler Drug: Indacaterol maleate / glycopyrronium bromide capsules Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016


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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02693769


Locations
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Slovakia
JURMED, s.r.o.
Košice, Slovakia, 040 01
Sponsors and Collaborators
Mundipharma Research Limited

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Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT02693769     History of Changes
Other Study ID Numbers: KFL3503
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Fluticasone
Glycopyrrolate
Bromides
Formoterol Fumarate
Maleic acid
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
Anticonvulsants
Enzyme Inhibitors
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents