A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
This study has been completed.
Sponsor:
Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01302587
First received: February 16, 2011
Last updated: June 21, 2012
Last verified: June 2012
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Purpose
This study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or COPD.
| Condition | Intervention |
|---|---|
|
Asthma Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis |
Drug: Albuterol |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
COPD (Chronic Obstructive Pulmonary Disease)
Chronic Bronchitis
Emphysema
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- The number of times the counter advanced but the inhaler did not actuate [ Time Frame: Days 1 through 46 ] [ Designated as safety issue: No ]MDI actuates but the counter display does not advance.
Secondary Outcome Measures:
- The number of times the inhaler actuated but the counter did not advance. [ Time Frame: Days 1 through 46 ] [ Designated as safety issue: No ]Counter advances but the MDI does not actuate.
| Enrollment: | 306 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Albuterol MDI
All participants in this study will receive an albuterol MDI inhaler.
|
Drug: Albuterol
Albuterol MDI with integrated dose counter. Each participant will use 2 oral inhalations of 90 micrograms each of albuterol twice a day for the length of the study.
|
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)
Criteria
Inclusion Criteria:
- Written informed consent/assent
- General good health
- Asthma or COPD
- Capable of understanding the requirements, risks, and benefits of study participation.
- Able to demonstrate proper metered-dose inhaler use and technique.
- Other inclusion criteria apply
Exclusion Criteria:
- History of life-threatening asthma or COPD that is defined for this protocol as an asthma or COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
- Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of Screening Visit.
- Is being treated with a long-acting β2-agonist alone.
- Is currently being treated with Ventolin HFA.
- Any asthma or COPD exacerbation requiring oral corticosteroids within 2 months of Screening Visit. A subject must not have had any hospitalization for asthma or COPD within 4 months prior to Screening Visit.
- Historical or current evidence of a clinically significant non-asthmatic acute or chronic condition.
- Uncontrolled hypertension
- History of any adverse reaction to any component of the HFA-MDI formulation.
- Participation in any investigational drug study within the 30 days preceding the Screening Visit.
- Other exclusion criteria apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302587
Show 25 Study Locations
Show 25 Study LocationsSponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
| Study Director: | Clinical Project Leader | Teva Respiratory R&D |
More Information
No publications provided by Teva Pharmaceutical Industries
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ) |
| ClinicalTrials.gov Identifier: | NCT01302587 History of Changes |
| Other Study ID Numbers: | ABM-AS-307 |
| Study First Received: | February 16, 2011 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchitis Bronchitis, Chronic Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Respiratory Tract Infections Pathologic Processes Albuterol Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents |
ClinicalTrials.gov processed this record on May 22, 2013