HealthyPhase 1NCT00418509
Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers
A Phase 1 study testing Mometasone furoate and Formoterol fumarate in people with Healthy, run by Novartis at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mometasone furoate and Formoterol fumarate
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Mometasone furoate, Formoterol fumarate
- Keywords
- Dose proportionality, pharmacokinetics, mometasone, formoterol, Healthy volunteers study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoateDrug
Formoterol fumarateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schering-Plough
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418509
- Sponsor's protocol ID
- CFOR258H2104
- Status last verified
- Jun 2007
- First submitted
- 4 Jan 2007
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00418509
- Acronym / sponsor ID
- CFOR258H2104
- Conditions
- Healthy
- Keywords
- Dose proportionality, pharmacokinetics, mometasone, formoterol, Healthy volunteers study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Schering-Plough
- Study start
- Nov 2006
- First posted
- 5 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone furoate | Drug | – |
| Formoterol fumarate | Drug | – |
Primary outcome
Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).
2 secondary outcomes
Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.
Plasma and urine concentrations mometasone and formoterol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mometasone furoate and Formoterol fumarate in people with Healthy, run by Novartis at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2007.