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

This study has been completed.

Study NCT00583947 Information provided by Sunovion

First Received on December 21, 2007. Last Updated on June 20, 2011 History of Changes

Results First Received: November 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: arformoterol Drug: levalbuterol

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
86 subjects were screened: 23 subjects aged 2-5 years and 63 subjects aged 6-11 years.

Reporting Groups

	Description
ARF/LEV	Cross-over period: 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 period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
LEV/ARF	Cross-over period: 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 period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

Description

ARF/LEV

Cross-over period: 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 period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

LEV/ARF

Cross-over period: 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 period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

Participant Flow for 3 periods

Period 1: Cross-over Period

	ARF/LEV	LEV/ARF
STARTED	27 ^[1]	26 ^[1]
COMPLETED	22	24
NOT COMPLETED	5	2
Adverse Event	2	0
Withdrawal by Subject	2	0
Did not meet-no longer met entry criteri	0	1
not specified	1	1

[1]	Participants were stratified by age group at randomization: ages 2-5 yrs and 6-11 years

Period 2: Washout

	ARF/LEV	LEV/ARF
STARTED	22	24
COMPLETED	22	24
NOT COMPLETED	0	0

Period 3: Open Label Period

	ARF/LEV	LEV/ARF
STARTED	22 ^[1]	24 ^[1]
COMPLETED	22	24
NOT COMPLETED	0	0

[1]	3 subjects were dosed with arformoterol 7.5 microgram in error

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
ARF/LEV	Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization. Open label: 7 day washout; arformoterol 15 microgram per nebulization.
LEV/ARF	Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization. Open label: 7 day washout; arformoterol 15 microgram per nebulization.

Description

ARF/LEV

Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.

Open label: 7 day washout; arformoterol 15 microgram per nebulization.

LEV/ARF

Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.

Open label: 7 day washout; arformoterol 15 microgram per nebulization.

Baseline Measures

	ARF/LEV	LEV/ARF	Total
Number of Participants [units: participants]	27	26	53
Age [units: participants]
<=18 years	27	26	53
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation
Age 2-5 years	4.4 ± 0.79	4.4 ± 0.79	4.4 ± 0.76
Age 6-11 years	9.0 ± 1.26	8.5 ± 1.43	8.8 ± 1.35
Gender [units: participants]
Female	13	12	25
Male	14	14	28
Race/Ethnicity, Customized [units: participants]
White/Caucasian	19	12	31
Black/African American	6	14	20
Other	2	0	2
Region of Enrollment [units: participants]
United States	27	26	53
Height [units: centimeters] Mean ± Standard Deviation	131.62 ± 15.244	130.42 ± 15.377	131.03 ± 15.174
Weight [units: kilograms] Mean ± Standard Deviation	31.57 ± 12.106	32.68 ± 12.802	32.12 ± 12.345

Outcome Measures

Show All Outcome Measures

1. Primary:

Mean Heart Rate [ Time Frame: predose, various timeframes up to 5 hours post last dose ]

Show Outcome Measure 1

2. Primary:

Change From Predose in Mean Heart Rate [ Time Frame: predose, various timeframes up to 5 hours post last dose ]

Show Outcome Measure 2

3. Primary:

Mean Systolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ]

Show Outcome Measure 3

4. Primary:

Change From Predose in Mean Systolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ]

Show Outcome Measure 4

5. Primary:

Mean Diastolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ]

Show Outcome Measure 5

6. Primary:

Change From Predose in Mean Diastolic Blood Pressure [ Time Frame: predose, various timeframes up to 5 hours post last dose ]

Show Outcome Measure 6

7. Primary:

Mean Serum Potassium Levels [ Time Frame: Predose, 2 hours and 6 hours postdose 1 ]

Show Outcome Measure 7

8. Primary:

Change From Predose in Mean Serum Potassium [ Time Frame: predose, 2 and 6 hours post dose ]

Show Outcome Measure 8

9. Primary:

Mean Serum Glucose Values [ Time Frame: Predose, 2 and 6 hours post dose 1 ]

Show Outcome Measure 9

10. Primary:

Change From Predose in Mean Serum Glucose [ Time Frame: predose, 2 and 6 hours post dose ]

Show Outcome Measure 10

11. Secondary:

Mean Forced Expiratory Volume in One Second(FEV1) [ Time Frame: predose, various postdose times ]

Show Outcome Measure 11

12. Secondary:

Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) [ Time Frame: predose, various postdose timepoints ]

Show Outcome Measure 12

13. Secondary:

Mean Peak Expiratory Flow Rate (PEFR) [ Time Frame: predose, various postdose times ]

Show Outcome Measure 13

14. Secondary:

Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) [ Time Frame: predose, various postdose times ]

Show Outcome Measure 14

15. Secondary:

Plasma Concentration of (R,R) Formoterol [ Time Frame: predose, various postdose times ]

Show Outcome Measure 15

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sample size was determined outside of statistical considerations. All data recorded at/after Visit 8 for 6 subjects, misdosed with ARF 7.5mcg instead of ARF 15mcg in open-label period, were excluded from the planned efficacy, PK and safety analyses.

Results Point of Contact:

Name/Title: Respiratory Medical Director
Organization: Sepracor Inc
phone: 866-503-6351

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