Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

April 5, 2018 updated by: Orion Corporation, Orion Pharma

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak plasma concentration (Cmax) of salmeterol
Time Frame: between 0-34 hours after dosing
Cmax of salmeterol
between 0-34 hours after dosing
Peak plasma concentration (Cmax) of fluticasone propionate
Time Frame: between 0-34 hours after dosing
Cmax of fluticasone propionate
between 0-34 hours after dosing
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
0-34 hours after dosing
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
0-34 hours after dosing
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
0-30 minutes after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
0-34 hours after dosing and extrapolation
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
0-34 hours after dosing and extrapolation
The time to reach the maximum concentration (tmax) of salmeterol
Time Frame: 0-34 hours after dosing
tmax of salmeterol
0-34 hours after dosing
The time to reach the maximum concentration (tmax) of fluticasone propionate
Time Frame: 0-34 hours after dosing
tmax of fluticasone propionate
0-34 hours after dosing
The terminal elimination half-life (t1/2) of salmeterol
Time Frame: 0-34 hours after dosing
t1/2 of salmeterol
0-34 hours after dosing
The terminal elimination half-life (t1/2) of fluticasone propionate
Time Frame: 0-34 hours after dosing
t1/2 of fluticasone propionate
0-34 hours after dosing

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: through study completion, an average of 6 weeks
Adverse events
through study completion, an average of 6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orion Corporation, Orion Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ulla Sairanen, Orion Corporation, Orion Pharma

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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