A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583947
• Other study ID #: 091-029
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: February 21, 2012
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Heart Rate	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).	predose, various timeframes up to 5 hours post last dose	No
Primary	Change From Predose in Mean Heart Rate	Heart rate measured at various timepoints minus the heart rate at predose.	predose, various timeframes up to 5 hours post last dose	No
Primary	Mean Systolic Blood Pressure	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).	predose, various timeframes up to 5 hours post last dose	No
Primary	Change From Predose in Mean Systolic Blood Pressure	Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose	predose, various timeframes up to 5 hours post last dose	No
Primary	Mean Diastolic Blood Pressure	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).	predose, various timeframes up to 5 hours post last dose	No
Primary	Change From Predose in Mean Diastolic Blood Pressure	Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure	predose, various timeframes up to 5 hours post last dose	No
Primary	Mean Serum Potassium Levels		Predose, 2 hours and 6 hours postdose 1	No
Primary	Change From Predose in Mean Serum Potassium	Change in mean serum potassium at the specified timepoint minus the predose value.	predose, 2 and 6 hours post dose	No
Primary	Mean Serum Glucose Values		Predose, 2 and 6 hours post dose 1	No
Primary	Change From Predose in Mean Serum Glucose	Change in mean serum glucose at the specified timepoint minus the predose value.	predose, 2 and 6 hours post dose	No
Secondary	Mean Forced Expiratory Volume in One Second(FEV1)	Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.	predose, various postdose times	No
Secondary	Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)	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.	predose, various postdose timepoints	No
Secondary	Mean Peak Expiratory Flow Rate (PEFR)	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.	predose, various postdose times	No
Secondary	Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)	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.	predose, various postdose times	No
Secondary	Plasma Concentration of (R,R) Formoterol	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.	predose, various postdose times	No