NCT00418509

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
Last Updated

June 22, 2007

Status Verified

June 1, 2007

First QC Date

January 4, 2007

Last Update Submit

June 21, 2007

Conditions

Healthy

Keywords

Dose proportionalitypharmacokineticsmometasoneformoterolHealthy volunteers study

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.

  • Plasma and urine concentrations mometasone and formoterol

Interventions

Mometasone furoateDRUG
Formoterol fumarateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Horsham, United Kingdom

Location

MeSH Terms

Interventions

Mometasone FuroateFormoterol Fumarate

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Novartis

    Investigator site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 5, 2007

Study Start

November 1, 2006

Last Updated

June 22, 2007

Record last verified: 2007-06

Locations

GB(1)