AsthmaPhase 4NCT00250341
Non-invasive Measures of Distal Lung Disease in Asthmatics
A Phase 4 study testing QVAR, Advair and Servent Diskus in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
This is a Phase 4, single center study conducted in mild-to moderate asthmatics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- QVAR, Advair and Servent Diskus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2005to 30 Sep 2007
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Currently using SABA prn or a low-to-moderate persistent asthma
Who cannot join
- Tobacco use within 1 year or >= 5 pack years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung
This is a Phase 4, single center study conducted in mild-to moderate asthmatics.
Read the detailed description
The study consists of 3 phases. There are 7 study visits.
- Conditions
- Asthma
- Being tested
- QVAR, Advair, Servent Diskus
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QVARDrug
Also called beclomethasone dipropionate HFA
480 mcg
AdvairDrug
Also called Advair Diskus
250/50 mcg
Servent DiskusDrug
50 mcg
| Study group | Role | What they receive |
|---|---|---|
| Advair | Active comparator | Not described Receives: Drug: Advair |
| QVAR | Experimental | Not described Receives: Drug: QVAR; Drug: Servent Diskus |
What is being measured
The primary outcome is the main question the study is designed to answer.
High resolution Cat Scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study start30 Sep 2005
- Primary completion30 Sep 2007
- Study completion30 Sep 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Zeidler, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250341
- Sponsor's protocol ID
- IXR-403-4-196
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2005
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung
- ClinicalTrials.gov ID
- NCT00250341
- Acronym / sponsor ID
- IXR-403-4-196
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2005 (actual)
- Primary completion
- 30 Sep 2007 (actual)
- Study completion
- 30 Sep 2007 (actual)
- First posted
- 8 Nov 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 is a Phase 4, single center study conducted in mild-to moderate asthmatics.
Detailed description
The study consists of 3 phases. There are 7 study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advair | Active comparator | Drug: Advair |
| QVAR | Experimental | Drug: QVAR, Drug: Servent Diskus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- Currently using SABA prn or a low-to-moderate persistent asthma
Key exclusion criteria (1 listed)
- Tobacco use within 1 year or >= 5 pack years
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 |
|---|---|---|
| QVARAlso: beclomethasone dipropionate HFA480 mcg | Drug | QVAR |
| AdvairAlso: Advair Diskus250/50 mcg | Drug | Advair |
| Servent Diskus50 mcg | Drug | QVAR |
Primary outcome
High resolution Cat Scans
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 2 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.
Michelle Zeidler, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing QVAR, Advair and Servent Diskus in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site 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 2 inclusion and 1 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 2 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 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
High resolution Cat Scans. It is what the study was designed to measure, not a finding.
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 2 Dec 2021.