Status:
COMPLETED
Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
Lead Sponsor:
Novartis
Collaborating Sponsors:
Schering-Plough
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE2
Brief Summary
This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and duration of action), of a single dose of formoterol fumarate in combination with mometasone furoate to placebo...
Eligibility Criteria
Inclusion
- 5 to 11 years of age of either sex and of any race
- A diagnosis (according to the Global Initiative for Asthma \[GINA\] guidelines) of persistent asthma for a period of at least 6 months prior to screening and must have been on a stable asthma regimen (daily dose unchanged) for at least 4 weeks prior to screening
- β2-agonist reversibility, defined as an increase in absolute FEV1 of ≥12% within 30 minutes after administration of 200μg of salbutamol without the use of a spacer or its equivalent in accordance with ATS/ERS standards
- A child must have an FEV1 of ≥ 60% and ≤ 90% of Polgar predicted when all restricted medications have been withheld for the appropriate intervals
Exclusion
- Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer.
- History of malignancy of any organ system within past 5 years.
- Pre-dose change (increase or decrease) in absolute FEV1 of 15% at Visit 2, compared with value at screening.
- Hospitalized or had an emergency room treatment for an acute asthma exacerbation in the 1 month prior to Visit 1, or who had a clinical deterioration of asthma between Visits 1 and 2 that resulted in emergency treatment, hospitalization, or treatment with excluded asthma medication.
- Significant medication condition or situation.
- QTc \> 440 msec (boys) or \> 450 msec (girls) on electrocardiogram(ECG) assessment at screening.
- Upper or lower respiratory tract infection within 4 weeks prior to screening.
- Chronic conditions affecting the respiratory tract or chronic lung diseases.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00746330
Start Date
August 1 2008
End Date
April 1 2009
Last Update
June 7 2011
Active Locations (9)
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1
Novartis Investigative Site
Mobile, Alabama, United States, 36608
2
Novartis Investigative Site
Huntington Beach, California, United States, 92647
3
Novartis Investigative Site
Orange, California, United States, 92868
4
Novartis Investigative Site
Hialeah, Florida, United States, 33012