AsthmaNCT01302587
A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
An observational study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Teva Branded Pharmaceutical Products R&D, Inc. at 25 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Emphysema
- What is being tested?
- Albuterol
- Type of treatment
- Pill or oral medicine
- How many people
- 306 participants
- Where
- 25 sitesUnited States
- Study dates
- Mar 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Teva Clinical Study Site 10085
Canton, Ohio
Teva Clinical Study Site
Dallas, Texas
Teva Clinical Study Site 10088
Eugene, Oregon
Teva Clinical Study Site
Fall River, Massachusetts
Teva Clinical Study Site
Glendale, Arizona
Teva Clinical Study Site 10081
Greenville, South Carolina
Teva Clinical Study Site 10083
High Point, North Carolina
Teva Clinical Study Site 10090
Indianapolis, Indiana
Teva Clinical Study Site
Miami, Florida
Teva Clinical Study Site 10086
Minneapolis, Minnesota
Teva Clinical Study Site 10100
Mission Viejo, California
Teva Clinical Study Site 10091
New Braunfels, Texas
Teva Clinical Study Site 10094
North Dartmouth, Massachusetts
Teva Clinical Study Site 10093
Orange, California
Teva Clinical Study Site 10082
Ormond Beach, Florida
Teva Clinical Study Site 10097
Overland Park, Kansas
Teva Clinical Study Site 10095
Portland, Oregon
Teva Clinical Study Site 10092
Raleigh, North Carolina
Teva Clinical Study Site 10089
San Diego, California
Teva Clinical Study Site 10099
Seattle, Washington
Teva Clinical Study Site 10084
Spartanburg, South Carolina
Teva Clinical Study Site
Tamarac, Florida
Teva Clinical Study Site 10080
Tulsa, Oklahoma
Teva Clinical Study Site 10098
Wheat Ridge, Colorado
Teva Clinical Study Site 10087
Wichita, Kansas
About this study
Official title: A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter
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.
- Being tested
- Albuterol
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuterolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Albuterol MDI | All participants in this study will receive an albuterol MDI inhaler. Receives: Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of times the counter advanced but the inhaler did not actuate
MDI actuates but the counter display does not advance.
Measured: Days 1 through 46
Secondary outcomes (1)
The number of times the inhaler actuated but the counter did not advance.
Counter advances but the MDI does not actuate.
Measured: Days 1 through 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Project Leader, Study director, Teva Respiratory R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302587
- Sponsor's protocol ID
- ABM-AS-307
- Status last verified
- Jun 2012
- First submitted
- 16 Feb 2011
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Given J, Taveras H, Iverson H, Lepore M. Prospective, open-label assessment of albuterol sulfate hydrofluoroalkane metered-dose inhaler with new integrated dose counter. Allergy Asthma Proc. 2013 Jan-Feb;34(1):42-51. doi: 10.2500/aap.2012.33.3647. Epub 2012 Dec 20.
PubMed 23265285
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter
- ClinicalTrials.gov ID
- NCT01302587
- Acronym / sponsor ID
- ABM-AS-307
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albuterol MDI | – | Drug: AlbuterolAll participants in this study will receive an albuterol MDI inhaler. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuterolAlbuterol 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. | Drug | Albuterol MDI |
Primary outcome
The number of times the counter advanced but the inhaler did not actuate
Time frame: Days 1 through 46
MDI actuates but the counter display does not advance.
1 secondary outcome
The number of times the inhaler actuated but the counter did not advance.
Time frame: Days 1 through 46
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
- Derived from this study: PubMed 23265285Given J, Taveras H, Iverson H, Lepore M. Prospective, open-label assessment of albuterol sulfate hydrofluoroalkane metered-dose inhaler with new integrated dose counter. Allergy Asthma Proc. 2013 Jan-Feb;34(1):42-51. doi: 10.2500/aap.2012.33.3647. Epub 2012 Dec 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Project Leader study director
Teva Respiratory R&D
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Teva Branded Pharmaceutical Products R&D, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of times the counter advanced but the inhaler did not actuate (time frame: Days 1 through 46). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01302587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.