Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: salmeterol-fluticasone; Drug: salmeterol-fluticasone; Drug: salmeterol-fluticasone; Drug: salmeterol-fluticasone

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Clinical Pharmacology Unit, Orion Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Seretide Diskus; salmeterol-fluticasone 2 inhalations as a single dose	Drug: salmeterol-fluticasone; Seretide Diskus 50/250 µg/dose; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
Experimental: Salmeterol/fluticasone Easyhaler, E; salmeterol-fluticasone 2 inhalations as a single dose	Drug: salmeterol-fluticasone; Seretide Diskus 50/250 µg/dose; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
Experimental: Salmeterol/fluticasone Easyhaler, F; salmeterol-fluticasone 2 inhalations as a single dose	Drug: salmeterol-fluticasone; Seretide Diskus 50/250 µg/dose; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
Experimental: Salmeterol/fluticasone Easyhaler, G; salmeterol-fluticasone 2 inhalations as a single dose	Drug: salmeterol-fluticasone; Seretide Diskus 50/250 µg/dose; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F; Drug: salmeterol-fluticasone; Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax) of salmeterol	Cmax of salmeterol	between 0-34 hours after dosing
Peak plasma concentration (Cmax) of fluticasone propionate	Cmax of fluticasone propionate	between 0-34 hours after dosing
Area under the plasma concentration versus time curve (AUC) of salmeterol	AUC from time zero to the last sample with the quantifiable concentration	0-34 hours after dosing
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate	AUC from time zero to the last sample with the quantifiable concentration	0-34 hours after dosing
Truncated area under the plasma concentration versus time curve (AUC) of salmeterol	AUC from time zero to 30 min after study treatment administration	0-30 minutes after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC) of salmeterol	AUC from time zero to infinity	0-34 hours after dosing and extrapolation
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate	AUC from time zero to infinity	0-34 hours after dosing and extrapolation
The time to reach the maximum concentration (tmax) of salmeterol	tmax of salmeterol	0-34 hours after dosing
The time to reach the maximum concentration (tmax) of fluticasone propionate	tmax of fluticasone propionate	0-34 hours after dosing
The terminal elimination half-life (t1/2) of salmeterol	t1/2 of salmeterol	0-34 hours after dosing
The terminal elimination half-life (t1/2) of fluticasone propionate	t1/2 of fluticasone propionate	0-34 hours after dosing

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events	through study completion, an average of 6 weeks

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Study Director: Ulla Sairanen, Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): December 19, 2017
• Study Completion (Actual): December 19, 2017

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: 3106012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No