Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

NCT03238482 | Completed Phase 1

• 1 other identifier: 3106012
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Area under the plasma concentration versus time curve (AUC) of salmeterol

  0-34 hours after dosing and extrapolation

• Area under the plasma concentration versus time curve (AUC) of fluticasone propionate

  0-34 hours after dosing and extrapolation

• The time to reach the maximum concentration (tmax) of salmeterol

  0-34 hours after dosing

• The time to reach the maximum concentration (tmax) of fluticasone propionate

  0-34 hours after dosing

• The terminal elimination half-life (t1/2) of salmeterol

  0-34 hours after dosing

Other Outcomes (1)

• Adverse events

  through study completion, an average of 6 weeks

Study Arms (4)

Seretide Diskus

ACTIVE COMPARATOR

salmeterol-fluticasone 2 inhalations as a single dose

Drug: salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler, E

EXPERIMENTAL

salmeterol-fluticasone 2 inhalations as a single dose

Drug: salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler, F

EXPERIMENTAL

salmeterol-fluticasone 2 inhalations as a single dose

Drug: salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler, G

EXPERIMENTAL

salmeterol-fluticasone 2 inhalations as a single dose

Drug: salmeterol-fluticasone

Interventions

salmeterol-fluticasone DRUG

Seretide Diskus 50/250 µg/dose

Seretide Diskus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
• Any condition requiring regular concomitant treatment.
• 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.
• Known hypersensitivity to the active substance(s) or the lactose.
• Pregnant or lactating females and females of childbearing potential not using proper contraception.
• Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration.
• Administration of another investigational medicinal product within 90 days prior to first study treatment administration.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Pharmacology Unit, Orion Pharma

Espoo, Finland

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ulla Sairanen

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: August 3, 2017
• Study Start: August 16, 2017
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

FI (1)