Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers - Full Text View

Sponsor:	Novartis
Collaborator:	Schering-Plough
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00418509

Purpose

This study will compare the performance of three combination metered dose inhalation devices and the variability of mometasone and formoterol doses delivered to the lungs in a healthy volunteer population

Condition	Intervention	Phase
Healthy	Drug: Mometasone furoate Drug: Formoterol fumarate	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Single Dose, 3-Period Crossover Study to Evaluate the Dosage Form Proportionality, Dose Proportionality and Pharmacokinetics of Mometasone Furoate and Formoterol Fumarate From Three Combination MDI Formulations

Resource links provided by NLM:

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Mometasone furoate Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).

Secondary Outcome Measures:

Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.
Plasma and urine concentrations mometasone and formoterol

Estimated Enrollment:	24
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, male or female subjects age 18 to 65 years of age (included)
In good health as confirmed by past medical history
Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years)
Body mass index (BMI) within the range of 18.5 to 32 kg/m2 and weigh at least 50 kg
Able to communicate well with the investigator, to understand and comply with the requirements of the study
Understand and sign the written informed consent

Exclusion Criteria:

Smokers (use of tobacco products in the previous 1 year with a pack year history of no greater than 10 pack years).
Female subjects who are pregnant, or lactating
Treatment with any oral or intravenous corticosteroids within 1 month of the first study treatment.
Patients with a current respiratory tract infection or one within 1 month prior to screening.
Patients with a history of malignancy, myocardial infarction, untoward reactions to sympathomimetic amines or inhaled medicine.

Subjects with a current or history of a clinically significant cardiac arrhythmia.

Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
Significant illness within the two weeks prior to dosing.
A past medical history of clinically significant ECG abnormalities.
History of fainting, known hypersensitivity to the study drug or drugs similar to the study drug. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, immunocompromise, including a positive HIV (ELISA and Western blot) test result, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result, drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening evaluations.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418509

Locations

United Kingdom
Novartis
Horsham, United Kingdom

Sponsors and Collaborators

Novartis

Schering-Plough

Investigators

Principal Investigator:

Novartis

Investigator site

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00418509 History of Changes
Other Study ID Numbers:	CFOR258H2104
Study First Received:	January 4, 2007
Last Updated:	June 21, 2007
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Dose proportionality
pharmacokinetics
mometasone
formoterol
Healthy volunteers study

Additional relevant MeSH terms:

Formoterol
Mometasone furoate
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012