A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: arformoterol (Drug); levalbuterol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sunovion Official(s) and/or principal investigator(s): Pulmonary Medical Director, Study Chair, Affiliation: Unicorn Pharma Consulting
Summary
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Heart RateChange From Predose in Mean Heart Rate Mean Systolic Blood Pressure Change From Predose in Mean Systolic Blood Pressure Mean Diastolic Blood Pressure Change From Predose in Mean Diastolic Blood Pressure Mean Serum Potassium Levels Change From Predose in Mean Serum Potassium Mean Serum Glucose Values Change From Predose in Mean Serum Glucose
Secondary outcome: Mean Forced Expiratory Volume in One Second(FEV1)Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) Mean Peak Expiratory Flow Rate (PEFR) Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) Plasma Concentration of (R,R) Formoterol
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
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
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.
Locations and Contacts
Beverly Hills, California 90211, United States
Orange, California 92868, United States
Savannah, Georgia 31406, United States
Normal, Illinois 61761, United States
Oklahoma City, Oklahoma 73112, United States
Oklahoma City, Oklahoma 73120, United States
Medford, Oregon 97504, United States
Portland, Oregon 97213, United States
Upland, Pennsylvania 19013, United States
Orangeburg, South Carolina 29118, United States
Spartanburg, South Carolina 29303, United States
Dallas, Texas 75230, United States
Burke, Virginia 22015, United States
Richmond, Virginia 23229, United States
Additional Information
Xopenex HCI Patient Prescribing Information Brovana Patient Medication Guide
Starting date: January 2008
Last updated: February 21, 2012
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