A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects - Full Text View

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00583947

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: arformoterol Drug: levalbuterol	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Potassium

Drug Information available for: Albuterol Formoterol fumarate Levalbuterol hydrochloride Albuterol sulfate Arformoterol Formoterol Arformoterol Tartrate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

Mean Heart Rate [ Time Frame: predose, various timeframes up to 5 hours post last dose ] [ Designated as safety issue: No ]
Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Change From Predose in Mean Heart Rate [ Time Frame: predose, various timeframes up to 5 hours post last dose ] [ Designated as safety issue: No ]
Heart rate measured at various timepoints minus the heart rate at predose.
Mean Systolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ] [ Designated as safety issue: No ]
Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Change From Predose in Mean Systolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ] [ Designated as safety issue: No ]
Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose
Mean Diastolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ] [ Designated as safety issue: No ]
Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Change From Predose in Mean Diastolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ] [ Designated as safety issue: No ]
Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure
Mean Serum Potassium Levels [ Time Frame: Predose, 2 hours and 6 hours postdose 1 ] [ Designated as safety issue: No ]
Change From Predose in Mean Serum Potassium [ Time Frame: predose, 2 and 6 hours post dose ] [ Designated as safety issue: No ]
Change in mean serum potassium at the specified timepoint minus the predose value.
Mean Serum Glucose Values [ Time Frame: Predose, 2 and 6 hours post dose 1 ] [ Designated as safety issue: No ]
Change From Predose in Mean Serum Glucose [ Time Frame: predose, 2 and 6 hours post dose ] [ Designated as safety issue: No ]
Change in mean serum glucose at the specified timepoint minus the predose value.

Secondary Outcome Measures:

Mean Forced Expiratory Volume in One Second(FEV1) [ Time Frame: predose, various postdose times ] [ Designated as safety issue: No ]
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) [ Time Frame: predose, various postdose timepoints ] [ Designated as safety issue: No ]
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.
Mean Peak Expiratory Flow Rate (PEFR) [ Time Frame: predose, various postdose times ] [ Designated as safety issue: No ]
PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) [ Time Frame: predose, various postdose times ] [ Designated as safety issue: No ]
PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.
Plasma Concentration of (R,R) Formoterol [ Time Frame: predose, various postdose times ] [ Designated as safety issue: No ]
If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero.

Enrollment:	53
Study Start Date:	January 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ARF/LEV Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.	Drug: arformoterol Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). Other Name: Brovana Drug: levalbuterol Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). Other Name: Xopenex
LEV/ARF Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.	Drug: arformoterol Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). Other Name: Brovana Drug: levalbuterol Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). Other Name: Xopenex

Arms

Assigned Interventions

ARF/LEV

Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.

Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

Drug: arformoterol

Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Other Name: Brovana

Drug: levalbuterol

Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Other Name: Xopenex

LEV/ARF

Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.

Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

Drug: arformoterol

Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Other Name: Brovana

Drug: levalbuterol

Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Other Name: Xopenex

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

Ages Eligible for Study:	2 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583947

Locations

United States, California

Beverly Hills, California, United States, 90211

Orange, California, United States, 92868
United States, Georgia

Savannah, Georgia, United States, 31406
United States, Illinois

Normal, Illinois, United States, 61761
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73112

Oklahoma City, Oklahoma, United States, 73120
United States, Oregon

Medford, Oregon, United States, 97504

Portland, Oregon, United States, 97213
United States, Pennsylvania

Upland, Pennsylvania, United States, 19013
United States, South Carolina

Orangeburg, South Carolina, United States, 29118

Spartanburg, South Carolina, United States, 29303
United States, Texas

Dallas, Texas, United States, 75230
United States, Virginia

Burke, Virginia, United States, 22015

Richmond, Virginia, United States, 23229

Sponsors and Collaborators

Sunovion

Investigators

Study Chair:

Pulmonary Medical Director

Unicorn Pharma Consulting

More Information

Additional Information:

Xopenex HCI Patient Prescribing Information This link exits the ClinicalTrials.gov site

Brovana Patient Medication Guide This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	James M. Hinson Jr., MD, FCCP, CPI, Unicorn Pharma Consulting
ClinicalTrials.gov Identifier:	NCT00583947 History of Changes
Other Study ID Numbers:	091-029
Study First Received:	December 21, 2007
Results First Received:	November 30, 2009
Last Updated:	June 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Asthma
Respiratory Tract Diseases

Additional relevant MeSH terms:

Respiratory Aspiration
Asthma
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Formoterol

Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on February 12, 2012