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
NCT ID: NCT00746330
Last Updated: 2011-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2008-08-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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F12M - PL - F12D - MFF
Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
Mometasone furoate/formoterol fumarate (MFF)
Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.
Formoterol fumarate 12 μg pMDI (F12M)
Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).
Formoterol fumarate 12 μg DPI (F12D)
Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).
Placebo to F12D
Placebo to formoterol fumarate DPI delivered via DPI
Placebo to F12M/MFF
Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
F12D - F12M - MFF - PL
Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
Mometasone furoate/formoterol fumarate (MFF)
Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.
Formoterol fumarate 12 μg pMDI (F12M)
Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).
Formoterol fumarate 12 μg DPI (F12D)
Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).
Placebo to F12D
Placebo to formoterol fumarate DPI delivered via DPI
Placebo to F12M/MFF
Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
MFF - F12D - PL - F12M
Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
Mometasone furoate/formoterol fumarate (MFF)
Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.
Formoterol fumarate 12 μg pMDI (F12M)
Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).
Formoterol fumarate 12 μg DPI (F12D)
Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).
Placebo to F12D
Placebo to formoterol fumarate DPI delivered via DPI
Placebo to F12M/MFF
Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
PL - MFF - F12M - F12D
Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
Mometasone furoate/formoterol fumarate (MFF)
Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.
Formoterol fumarate 12 μg pMDI (F12M)
Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).
Formoterol fumarate 12 μg DPI (F12D)
Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).
Placebo to F12D
Placebo to formoterol fumarate DPI delivered via DPI
Placebo to F12M/MFF
Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
Interventions
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Mometasone furoate/formoterol fumarate (MFF)
Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.
Formoterol fumarate 12 μg pMDI (F12M)
Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).
Formoterol fumarate 12 μg DPI (F12D)
Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).
Placebo to F12D
Placebo to formoterol fumarate DPI delivered via DPI
Placebo to F12M/MFF
Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
11 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
Novartis
INDUSTRY
Responsible Party
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Novartis
Locations
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Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Huntington Beach, California, United States
Novartis Investigative Site
Orange, California, United States
Novartis Investigative Site
Hialeah, Florida, United States
Novartis Investigative Site
Pensacola, Florida, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Barranquilla, , Colombia
Novartis Investigative Site
Bogotá, , Colombia
Novartis Investigative Site
Lima, , Peru
Countries
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Other Identifiers
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CMFF258C2204
Identifier Type: -
Identifier Source: org_study_id
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