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

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00418509
First received: January 4, 2007
Last updated: June 21, 2007
Last verified: June 2007
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 27, 2014