Clinical trial NCT00583947: A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Official title: A Cumulative Dose Safety and Tolerability Crossover Study of Arformoterol Tartrate Inhalation Solution and Levalbuterol Hydrochloride Inhalation Solution in Pediatric Subjects (Aged 2 to 11 Years of Age) With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Respiratory Tract Diseases
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 53
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

Detailed description: A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility criteria: Inclusion Criteria:

* Male and Female
* Between Age 2 and 11, inclusive, at the time of consent
* Weight equal to or greater than 15 Kg
* History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.

Exclusion Criteria:

* Female subject who is pregnant or lactating.
* Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
* Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures.
* Subject with a history of cancer.
* Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
* Subject with a history of cigarette smoking or use of any tobacco products.

Primary outcomes:
measure: Mean Heart Rate
timeFrame: predose, various timeframes up to 5 hours post last dose
measure: Change From Predose in Mean Heart Rate
timeFrame: predose, various timeframes up to 5 hours post last dose
measure: Mean Systolic Blood Pressure
timeFrame: predose, various timeframes up to 5 hours post last dose
measure: Change From Predose in Mean Systolic Blood Pressure
timeFrame: predose, various timeframes up to 5 hours post last dose
measure: Mean Diastolic Blood Pressure
timeFrame: predose, various timeframes up to 5 hours post last dose
measure: Change From Predose in Mean Diastolic Blood Pressure
timeFrame: predose, various timeframes up to 5 hours post last dose
measure: Mean Serum Potassium Levels
timeFrame: Predose, 2 hours and 6 hours postdose 1
measure: Change From Predose in Mean Serum Potassium
timeFrame: predose, 2 and 6 hours post dose
measure: Mean Serum Glucose Values
timeFrame: Predose, 2 and 6 hours post dose 1
measure: Change From Predose in Mean Serum Glucose
timeFrame: predose, 2 and 6 hours post dose
Secondary outcomes:
measure: Mean Forced Expiratory Volume in One Second(FEV1)
timeFrame: predose, various postdose times
measure: Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
timeFrame: predose, various postdose timepoints
measure: Mean Peak Expiratory Flow Rate (PEFR)
timeFrame: predose, various postdose times
measure: Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
timeFrame: predose, various postdose times
measure: Plasma Concentration of (R,R) Formoterol
timeFrame: predose, various postdose times
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Orange
country: United States
state: California
city: Savannah
country: United States
state: Georgia
city: Normal
country: United States
state: Illinois
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Upland
country: United States
state: Pennsylvania
city: Orangeburg
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Unicorn Pharma Consulting
name: Pulmonary Medical Director
role: STUDY_CHAIR
References:
citation: Hinkle J, Hinson J, Kerwin E, Goodwin E, Sciarappa K, Curry L, Hanrahan JP. A cumulative dose, safety and tolerability study of arformoterol in pediatric subjects with stable asthma. Pediatr Pulmonol. 2011 Aug;46(8):761-9. doi: 10.1002/ppul.21446. Epub 2011 May 16.