Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers
This study has been completed.
Sponsor:
Novartis
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
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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:
Drug Information available for:
Formic acid
Formoterol fumarate
Formoterol
Mometasone furoate
Mometasone furoate monohydrate
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 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 May 22, 2013