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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418509
Recruitment Status : Completed
First Posted : January 5, 2007
Last Update Posted : June 22, 2007
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Mometasone furoate Drug: Formoterol fumarate Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2006

Primary Outcome Measures :
  1. Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).

Secondary Outcome Measures :
  1. Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.
  2. Plasma and urine concentrations mometasone and formoterol

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418509

United Kingdom
Horsham, United Kingdom
Sponsors and Collaborators
Principal Investigator: Novartis Investigator site Identifier: NCT00418509     History of Changes
Other Study ID Numbers: CFOR258H2104
First Posted: January 5, 2007    Key Record Dates
Last Update Posted: June 22, 2007
Last Verified: June 2007

Keywords provided by Novartis:
Dose proportionality
Healthy volunteers study

Additional relevant MeSH terms:
Formoterol Fumarate
Mometasone Furoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents