Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers

NCT01181063 | Completed Phase 1

• 1 other identifier: 3103005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known. The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.

Conditions

Asthma

Keywords

Asthma; Easyhaler

Outcome Measures

Primary Outcomes (1)

• The maximum observed concentration of concentration-time curve.

  24 hours

Secondary Outcomes (1)

• The area under the concentration-time curve from time zero to infinity, AUC∞

  24 hours

Study Arms (5)

400/12 μg D94-2BF (60/40) inhaler

EXPERIMENTAL

Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers

320/9 μg D94-2BF (20/80) inhaler

EXPERIMENTAL

Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers

Symbicort 320/9 μg inhaler

ACTIVE COMPARATOR

Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers

320/9 μg D94-2F (60/40) inhaler

EXPERIMENTAL

Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers

320/9 μg D94-2BF (60/40) inhaler

EXPERIMENTAL

Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers

Interventions

Budesonide/formoterol 320/9 μg and 400/12 μg inhalers DRUG

Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product

Also known as: Symbicort 320/9 μg inhaler

320/9 μg D94-2BF (20/80) inhaler; 320/9 μg D94-2BF (60/40) inhaler; 320/9 μg D94-2F (60/40) inhaler; 400/12 μg D94-2BF (60/40) inhaler; Symbicort 320/9 μg inhaler

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.
• Good general health ascertained by detailed medical history, and laboratory and physical examinations.
• Finnish speaking males and females, 18-60 (inclusive) years of age.
• Normal weight defined as body mass index (BMI) \> 19 and \< 30 kg/m2 (BMI = weight/height2)
• Weight at least 50 kg
• Hemoglobin 135-195 g/l male, 125-175 g/l female.

You may not qualify if:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
• Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
• Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed.
• Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram \[ECG\] and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
• Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
• History of vasovagal collapses.
• History of anaphylactic/anaphylactoid reactions.
• History of seizures including febrile seizures.
• Pregnant or lactating females.
• Females of childbearing potential not using proper contraception (mechanical and/or hormonal contraception, intrauterine device \[IUD\] or surgical sterilization) Note: Females of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator.
• Recent or current (suspected) drug abuse or positive result in the drugs abuse test.
• Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females \[1 unit = 4 cl spirits or equivalent\]).
• Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study(from the screening visit to the end-of study visit).
• Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24h after study treatment administration.
• Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Phase I Unit, Orion Pharma

Espoo, Finland

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Formoterol Fumarate; Nebulizers and Vaporizers; Budesonide, Formoterol Fumarate 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)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Equipment and Supplies; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Kimmo Ingman, MD, PhD

  Phase I Unit, Orion Pharma, Espoo, Finland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

FI (1)