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Trial record 10 of 318 for:    FLUTICASONE AND SALMETEROL

Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

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ClinicalTrials.gov Identifier: NCT03238482
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
The purpose of this study is to compare absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus

Condition or disease Intervention/treatment Phase
Asthma Drug: salmeterol-fluticasone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : December 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Seretide Diskus
salmeterol-fluticasone 2 inhalations as a single dose
Drug: salmeterol-fluticasone
Seretide Diskus 50/250 µg/dose

Experimental: Salmeterol/fluticasone Easyhaler, E
salmeterol-fluticasone 2 inhalations as a single dose
Drug: salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E

Experimental: Salmeterol/fluticasone Easyhaler, F
salmeterol-fluticasone 2 inhalations as a single dose
Drug: salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F

Experimental: Salmeterol/fluticasone Easyhaler, G
salmeterol-fluticasone 2 inhalations as a single dose
Drug: salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G




Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) of salmeterol [ Time Frame: between 0-34 hours after dosing ]
    Cmax of salmeterol

  2. Peak plasma concentration (Cmax) of fluticasone propionate [ Time Frame: between 0-34 hours after dosing ]
    Cmax of fluticasone propionate

  3. Area under the plasma concentration versus time curve (AUC) of salmeterol [ Time Frame: 0-34 hours after dosing ]
    AUC from time zero to the last sample with the quantifiable concentration

  4. Area under the plasma concentration versus time curve (AUC) of fluticasone propionate [ Time Frame: 0-34 hours after dosing ]
    AUC from time zero to the last sample with the quantifiable concentration

  5. Truncated area under the plasma concentration versus time curve (AUC) of salmeterol [ Time Frame: 0-30 minutes after dosing ]
    AUC from time zero to 30 min after study treatment administration


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of salmeterol [ Time Frame: 0-34 hours after dosing and extrapolation ]
    AUC from time zero to infinity

  2. Area under the plasma concentration versus time curve (AUC) of fluticasone propionate [ Time Frame: 0-34 hours after dosing and extrapolation ]
    AUC from time zero to infinity

  3. The time to reach the maximum concentration (tmax) of salmeterol [ Time Frame: 0-34 hours after dosing ]
    tmax of salmeterol

  4. The time to reach the maximum concentration (tmax) of fluticasone propionate [ Time Frame: 0-34 hours after dosing ]
    tmax of fluticasone propionate

  5. The terminal elimination half-life (t1/2) of salmeterol [ Time Frame: 0-34 hours after dosing ]
    t1/2 of salmeterol

  6. The terminal elimination half-life (t1/2) of fluticasone propionate [ Time Frame: 0-34 hours after dosing ]
    t1/2 of fluticasone propionate


Other Outcome Measures:
  1. Adverse events [ Time Frame: through study completion, an average of 6 weeks ]
    Adverse events



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main inclusion Criteria:

  1. Written informed consent (IC) obtained.
  2. Males and females, 18-60 (inclusive) years of age.
  3. Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2).
  4. Weight at least 50 kg.

Main exclusion Criteria:

  1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
  2. Any condition requiring regular concomitant treatment.
  3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
  4. Known hypersensitivity to the active substance(s) or the lactose.
  5. Pregnant or lactating females and females of childbearing potential not using proper contraception.
  6. Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration.
  7. Administration of another investigational medicinal product within 90 days prior to first study treatment administration.

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): NCT03238482


Locations
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Finland
Clinical Pharmacology Unit, Orion Pharma
Espoo, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Ulla Sairanen Orion Corporation, Orion Pharma

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03238482     History of Changes
Other Study ID Numbers: 3106012
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics