| September 14, 2007 |
| September 28, 2009 |
| January 2007 |
| October 2008 (final data collection date for primary outcome measure) |
| The percent change in the area-under-the-effect curve from test day baseline FEV1 versus time [ Time Frame: Study Days 1 and 2 ] [ Designated as safety issue: No ] |
| Improvement in Lung function test over 2 hour period following single dose of investigational drug treatment [ Time Frame: For up to 2 hour post treatment ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00530062 on ClinicalTrials.gov Archive Site |
- The maximum percent increase in FEV1 (%) from baseline within the scheduled first 30 minutes of spirometric evaluations post dose [ Time Frame: Study Days 1 and 2 ] [ Designated as safety issue: No ]
- The maximum percent increase in FEV1 from baseline over 2 hours [ Time Frame: Study days 1 and 2 ] [ Designated as safety issue: No ]
- The area-under-the-effect curve of change in FEV1 from test-day baseline versus time [ Time Frame: Study days 1 and 2 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI Versus Albuterol-HFA-MDI in Asthmatics |
| Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability |
This is a research study designed to compare the single-dose effectiveness of albuterol-HFA-BAI (breath activated inhaler) and albuterol-HFA-MDI (metered dose inhaler) in asthmatics with poor inhaler coordinating abilities. Patients must be 7 to 70 years of age to participate in this study. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Crossover Assignment |
| Asthma |
- Drug: Albuterol-HFA-MDI
- Drug: Albuterol-HFA-BAI
|
- Active Comparator: Albuterol Hydrofluoroalkane (HFA) Breath-Actuated Inhaler (BAI)
- Active Comparator: Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
|
| |
| |
| Completed |
| 49 |
| October 2008 |
| October 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male or females aged 7-70 years old
- Asthma of a minimum of 6 months duration
- Patients who demonstrate poor inhalation/actuation coordination when evaluated with the AIM -Aerosol Inhalation Monitor.
- Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
- The reversibility (FEV1) of <70% following administration of the initial 90 mcg of albuterol
- Ability to perform spirometry reproducibly
- Ability to self-perform PEF determinations and report scores on diaries
- Can tolerate withdrawal of applicable medications at screening
- Otherwise healthy individuals
- Non-smokers for at least two years
Exclusion Criteria:
- Allergy or sensitivity to albuterol
- Exposure to investigational drugs within 30 days prior to the screening visit
- Continuous treatment with Beta-blockers, MAO inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
- Treated with oral or injectable corticosteroids within the six weeks prior to the screening visit
- Unstable dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil
- Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
- Hospitalization for acute exacerbation of asthma more than twice in past year
- Treatment in an emergency room or hospitalization for asthmatic symptoms within three months prior to the screening visit
- An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved three weeks prior to the screening visit
- History and/or presence of any clinically significant non-asthmatic acute or chronic disease
- Known or suspected substance abuse
- Previous enrollment in an IVAX Research-sponsored Albuterol HFA asthma study
- Other criteria apply
|
| Both |
| 7 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00530062 |
| Clinical Study Leader, Teva Global Respiratory Research, LLC |
| IXR-404-04-167 |
| Teva Global Respiratory Research LLC |
|
| Study Chair: |
Clinical Study Leader |
Teva Global Respiratory Research LLC |
|
|
| Teva Global Respiratory Research LLC |
| September 2009 |