Phase 2
Completed N=32
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
Source: ClinicalTrials.gov NCT00746330 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment — 1.77; 1.77; 1.80; 1.71 liters
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 in children of 5-11 years with persistent asthma. The study will also assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI) to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted throughout the study to assess systemic exposure following administration of the study medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment |
1.77; 1.77; 1.80; 1.71 | — |
| SECONDARY Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect |
1.74; 1.77; 1.77; 1.68; 1.79; 1.80 | — |
| SECONDARY Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect |
2.09; 2.09; 2.09; 2.08; 2.12; 2.11 | — |
| SECONDARY Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect |
246.65; 248.17; 250.05; 237.85; 255.69; 253.37 | — |
| SECONDARY Plasma Formoterol Concentrations (Pmol/L) Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI) |
0; 0; 0; 13.1; 16.3; 18.56 | — |
| SECONDARY Urinary Excretion of Formoterol Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI) |
0.31; 0.52; 0.42; 1.14; 1.50; 1.33 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00746330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.