Chronic-Dose Safety and Efficacy Study of an Albuterol Metered Dose Inhaler (MDI) Inhaler Using a Hydrofluoroalkane (HFA) Propellant In Pediatric Asthmatics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:
NCT00577655
First received: December 18, 2007
Last updated: April 11, 2012
Last verified: April 2012

December 18, 2007
April 11, 2012
August 2007
July 2008   (final data collection date for primary outcome measure)
  • Maximum Percent Change From Baseline [ Time Frame: 2 hours following completion of dosing on Day 22 ] [ Designated as safety issue: No ]
    The FEV1 test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the amount of air blown over time. The maximum percent change from baseline in the Forced Expiratory Volume in one second (FEV1) observed up to 2 hours following completion of dosing using Day 22 baseline.
  • Maximum Percent Change in Peak Expiratory Flow (PEF) [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the amount of air blown over time. Maximum percent change in Peak Expiratory Flow (PEF) observed up to 2 hours following completion of dosing using Day 22 baseline.
The primary objective is to evaluate the chronic-dose safety and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics. [ Time Frame: 21 days of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00577655 on ClinicalTrials.gov Archive Site
  • Baseline Adjusted Area-under-the-effect-curve for Percent of Predicted FEV1 Over 6 Hours Post Dose [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Baseline
  • Baseline-adjusted area-under-the Effect Curve for Percent of Predicted FEV1 Over 6 Hours Post-dose on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 15% is Noted in Participants Who Responded to the Medication. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 15% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 12% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 12% is Noted [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Maximum FEVl [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Time (in Minutes) to Maximum PEF [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing to the Time at Which the FEVl First Decreases Below 15% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the FEVl First Decreases Below 12% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 15% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 12% [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Highest Daily Asthma Symptom Scores by Study Week [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms will be scored daily as 0 = No symptoms occurred, 1 = Symptom occurred but did not interfere with daily activity, 2 = Symptom occurred but was sometimes annoying or interfered with daily activity, 3 = Symptom present even at rest and was annoying or interfered with daily activity
  • The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • The Daily a.m. Pre-dose PEF [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • The Average Number of Puffs of Rescue Medication Per 24 Hour Period [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
Baseline-adjusted area-under-the effect curve for percent-=prdicted FEV1 and PEF over six hours post-dose. [ Time Frame: 6-hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Chronic-Dose Safety and Efficacy Study of an Albuterol Metered Dose Inhaler (MDI) Inhaler Using a Hydrofluoroalkane (HFA) Propellant In Pediatric Asthmatics
Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Eligible patients will be randomized to receive one of the following two treatments four times a day for 21 days:

Placebo in a metered-dose inhaler using a hydrofluoroalkane propellant (Placebo-HFA-MDI).

180 mcg of Albuterol in a metered-dose inhaler using a hydrofluoroalkane propellant (Albuterol-HFA-MDI)

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Albuterol
    Albuterol HFA MDI 180 mcg
  • Drug: Placebo
    Placebo HFA MDI
  • Experimental: 180 mcg of Albuterol
    Dosing with 180 mcg of albuterol in a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Albuterol HFA-MDI.")
    Intervention: Drug: Albuterol
  • Placebo Comparator: Placebo
    A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening.

Exclusion Criteria:

  • Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.
Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577655
IXR-302-25-105
No
Teva Branded Pharmaceutical Products, R&D Inc.
Teva Branded Pharmaceutical Products, R&D Inc.
Not Provided
Study Director: Teva Study Physician MD TEVA
Teva Branded Pharmaceutical Products, R&D Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP