Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers

NCT ID: NCT00418509

Last Updated: 2007-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Mometasone furoate

Intervention Type: DRUG

Formoterol fumarate

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis

Horsham, , United Kingdom

Countries

United Kingdom

Other Identifiers

CFOR258H2104

Identifier Type: -

Identifier Source: org_study_id