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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 Rate

Change 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

Page last updated: August 23, 2015

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