COPDNCT00238082
The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
A study testing HFA-134A Beclomethasone DIpropionate (QVAR) in people with COPD, run by National Jewish Health at 1 site in United States.
Trial summary
This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway "remodeling" or scarring in subjects with COPD. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD
- What is being tested?
- HFA-134A Beclomethasone DIpropionate (QVAR)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Feb 2005
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis
- FEV1/FVC<70%
- FEV1 50-80% predicted
- Albuterol response of <12% and <200mL or methacholine PC20 > 8mg/mL
- RV > 120% predicted
- DLCO < 80%
- smokers and nonsmokers
- Lower age limit 45 years
Who cannot join
- Asthma
- Other chronic airway or parenchymal lung disease
- Other comorbid illness (including but not limited to DM, MI or CAD-related intervention in 6 months, neurologic disease, syncope)
- Use of any steroid (oral, IV, nasal, pulmonary) within 12 weeks
- Use of theophylline, leukotriene modifiers within 12 weeks
- Use of long-acting beta-agonists (formoterol, salmeterol) or anticholinergic (tiotropium)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Medical and Research Center
Denver, Colorado, 80206
About this study
Official title: The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway "remodeling" or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo.
- Conditions
- COPD
- Being tested
- HFA-134A Beclomethasone DIpropionate (QVAR)
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
- Medical subject headings
- 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.
HFA-134A Beclomethasone DIpropionate (QVAR)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometric response (FEV1)
Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startNov 1999
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Investigators
- Richard Martin, MD, Principal investigator, National Jewish Medical and Research Center faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238082
- Sponsor's protocol ID
- HS-1277
- Status last verified
- Mar 2017
- First submitted
- 11 Oct 2005
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
- ClinicalTrials.gov ID
- NCT00238082
- Acronym / sponsor ID
- HS-1277
- Conditions
- COPD
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Nov 1999 (actual)
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 13 Oct 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 an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway "remodeling" or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- COPD diagnosis
- FEV1/FVC<70%
- FEV1 50-80% predicted
- Albuterol response of <12% and <200mL or methacholine PC20 > 8mg/mL
- RV > 120% predicted
Key exclusion criteria (6 listed)
- Asthma
- Other chronic airway or parenchymal lung disease
- Other comorbid illness (including but not limited to DM, MI or CAD-related intervention in 6 months, neurologic disease, syncope)
- Use of any steroid (oral, IV, nasal, pulmonary) within 12 weeks
- Use of theophylline, leukotriene modifiers within 12 weeks
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 |
|---|---|---|
| HFA-134A Beclomethasone DIpropionate (QVAR) | Drug | – |
Primary outcome
Spirometric response (FEV1)
Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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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.
Richard Martin, MD principal investigator
National Jewish Medical and Research Center faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFA-134A Beclomethasone DIpropionate (QVAR) in people with COPD, run by National Jewish Health 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Mar 2017. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Spirometric response (FEV1). The study lists 2 primary outcomes in all. 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 29 Mar 2017.