AsthmaPhase 2NCT00112411
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
A Phase 2 study testing Bronchodilator in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 9 sites in United States.
Trial summary
This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Bronchodilator
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- 30 Jun 2005to 30 Sep 2005
- Phase
- Phase 2
- 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 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Persistent asthma for a minimum of six months duration that has been stable for at least four weeks
- Predicted FEV1 60-90%
- Demonstration of 12% airway reversibility
Who cannot join
- Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled;
- Presence of clinically-significant non-asthmatic acute or chronic disease
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Allergy and Asthma Research Group
Eugene, Oregon, 97401
Mississippi Asthma and Allergy Clinic
Jackson, Mississippi, 39202
University of Louisville
Louisville, Kentucky, 40202
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
Allergy Associates Research Center
Portland, Oregon, 97213
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Allergy Associates Medical Group, Inc.
San Diego, California, 92120
Aeroallergy Research Labs of Savannah, Inc.
Savannah, Georgia, 31409
Medical Research Network
The Woodlands, Texas, 77380
About this study
Official title: Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.
- Conditions
- Asthma
- Being tested
- Bronchodilator
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchodilatorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study start30 Jun 2005
- Primary completion30 Sep 2005
- Study completion30 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112411
- Sponsor's protocol ID
- IXR-204-25-167
- Status last verified
- Dec 2021
- First submitted
- 2 Jun 2005
- Last updated
- 8 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
- ClinicalTrials.gov ID
- NCT00112411
- Acronym / sponsor ID
- IXR-204-25-167
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2005 (actual)
- Primary completion
- 30 Sep 2005 (actual)
- Study completion
- 30 Sep 2005 (actual)
- First posted
- 3 Jun 2005 (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 designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Persistent asthma for a minimum of six months duration that has been stable for at least four weeks
- Predicted FEV1 60-90%
- Demonstration of 12% airway reversibility
Key exclusion criteria (2 listed)
- Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled;
- Presence of clinically-significant non-asthmatic acute or chronic disease
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 |
|---|---|---|
| Bronchodilator | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bronchodilator in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 9 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 3 inclusion and 2 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 8 Dec 2021.