Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00308685
• Collaborator: (none)
• Enrollment: 95
• Locations: 14
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site: 6.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Albuterol; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics
• Actual Study Start Date: Jun 10, 2006
• Actual Primary Completion Date: Dec 4, 2006
• Actual Study Completion Date: Dec 4, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Albuterol-HFA-BAI ProAir(TM) HFA, Breath Actuated Inhalation Aerosol	Drug: Albuterol; Albuterol 90mcg
Placebo Comparator: Placebo-HFA-BAI Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22 [Baseline (Predose at Day 22), 2 hours postdose at Day 22]

   The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.

Secondary Outcome Measures

1. Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22 [Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22]

   Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening

• Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%

• Ability to perform spirometry

• Demonstrate 12% airways reversibility

Exclusion Criteria:

• Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids

• Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Little Rock Allergy and Asthma	Little Rock	Arkansas	United States	72205-4565
2	Allergy & Asthma Specialist Medical Group	Huntington Beach	California	United States	92647
3	Allergy & Asthma Associates of Santa Clara Valley Research Center	San Jose	California	United States	95117
4	William Storms Medical Research	Colorado Springs	Colorado	United States	80907
5	Colorado Allergy and Asthma Centers, PC	Denver	Colorado	United States	80230
6	Colorado Allergy and Asthma Centers, PC	Englewood	Colorado	United States	80112
7	Colorado Allergy and Asthma Centers, PC	Lakewood	Colorado	United States	80401
8	Southern Allergy & Asthma, PC	Savannah	Georgia	United States	31405
9	Sneeze, Wheeze & Itch Associates, Inc.	Normal	Illinois	United States	61761
10	Clinical Research Institute	Minneapolis	Minnesota	United States	55402
11	The Asthma & Allergy Center, PC	Papillion	Nebraska	United States	68046
12	Allergy and Respiratory Center	Canton	Ohio	United States	44718
13	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma	United States	73120
14	Pediatric Pulmonary Associates of North Texas	Dallas	Texas	United States	75230

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Teva Medical Expert, M.D., Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT00308685
• Other Study ID Numbers: IXR-303-25-167
• First Posted: Mar 30, 2006
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.: Asthma; Pediatric asthma
• Additional relevant MeSH terms: Asthma; Albuterol

Study Results

Participant Flow

Arm/Group Title	Albuterol-HFA-BAI	Placebo-HFA-BAI
Arm/Group Description	Participants received albuterol	Participants received placebo
Period Title: Overall Study
STARTED	50	45
Received at Least 1 Dose of Study Drug	50	45
COMPLETED	47	40
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Albuterol-HFA-BAI	Placebo-HFA-BAI	Total
Arm/Group Description	Participants received albuterol	Participants received placebo	Total of all reporting groups
Overall Participants	50	45	95
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.3 (2.22)	8.8 (1.58)	8.5 (1.96)
Sex: Female, Male (Count of Participants)
Female	27 54%	26 57.8%	53 55.8%
Male	23 46%	19 42.2%	42 44.2%
Race/Ethnicity, Customized (Count of Participants)
White	35 70%	36 80%	71 74.7%
Black	13 26%	9 20%	22 23.2%
Asian	1 2%	0 0%	1 1.1%
Other	1 2%	0 0%	1 1.1%
Forced Expiratory Volume in 1 Second (FEV1) (liters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [liters]	1.52 (0.44)	1.61 (0.38)	1.56 (0.42)

Outcome Measures

1. Primary Outcome

Title	Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22
Description	The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.
Time Frame	Baseline (Predose at Day 22), 2 hours postdose at Day 22

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of the assigned study medication and had at least 1 postdose spirometry measurement.

Arm/Group Title	Albuterol-HFA-BAI	Placebo-HFA-BAI
Arm/Group Description	Participants received albuterol	Participants received placebo
Measure Participants	50	45
Mean (Standard Error) [percent change]	13.807 (0.954)	8.644 (1.044)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albuterol-HFA-BAI, Placebo-HFA-BAI
	Comments	Analysis was performed using an analysis of covariance (ANCOVA) with baseline FEV1 as covariate and fixed effects of pooled center and treatment group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Threshold for significance at 0.05 level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in adjusted means
	Estimated Value	5.163
	Confidence Interval	(2-Sided) 95%; 2.478 to 7.847
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
Description	Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines.
Time Frame	Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who took at least 1 dose of the assigned study medication and had at least 1 postdose spirometry measurement.

Arm/Group Title	Albuterol-HFA-BAI	Placebo-HFA-BAI
Arm/Group Description	Participants received albuterol	Participants received placebo
Measure Participants	50	45
PPFEV1 AUEC0-6 on Day 22 Using Day 22 Baseline	29.473 (4.033)	11.672 (4.476)
PPFEV1 AUEC0-6 on Day 22 Using Day 1 Baseline	43.182 (6.036)	6.767 (6.572)

Adverse Events

Time Frame	Day 1 up to Day 22
Adverse Event Reporting Description	Safety population included all randomized participants who received at least 1 dose of their assigned study medication.
Arm/Group Title	Albuterol-HFA-BAI		Placebo-HFA-BAI
Arm/Group Description	Participants received albuterol		Participants received placebo
All Cause Mortality
	Albuterol-HFA-BAI		Placebo-HFA-BAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/45 (0%)
Serious Adverse Events
	Albuterol-HFA-BAI		Placebo-HFA-BAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Albuterol-HFA-BAI		Placebo-HFA-BAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.