Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: salmeterol-fluticasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03238482

3106012

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Seretide Diskus

Active Comparator group

Description:

salmeterol-fluticasone 2 inhalations as a single dose

Treatment:

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler, E

Experimental group

Description:

salmeterol-fluticasone 2 inhalations as a single dose

Treatment:

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler, F

Experimental group

Description:

salmeterol-fluticasone 2 inhalations as a single dose

Treatment:

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler, G

Experimental group

Description:

salmeterol-fluticasone 2 inhalations as a single dose

Treatment:

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone

Drug: salmeterol-fluticasone