Chronic Obstructive Pulmonary DiseaseNCT01096173
Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum
An observational study of Chronic Obstructive Pulmonary Disease, run by Pulmatrix Inc. at 1 site in United States.
Trial summary
This study is intended to be an evaluation of the properties of human sputum collected from patients with COPD. It is hypothesized that cationic airway lining modulators will have beneficial effects on the rheological properties of sputum derived from patients with COPD. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2010
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic setting
Who may be able to join
- Clinical and spirometric diagnosis of COPD
- Smoking history of at least 10 pack yrs
- Sputum production of greater than 2 tablespoons per day by patient report.
Who cannot join
- a primary diagnosis of asthma or bronchiectasis
- a COPD exacerbation within 4 weeks
- Inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the in Vitro Effects of CALM on COPD Sputum
This study is intended to be an evaluation of the properties of human sputum collected from patients with COPD. It is hypothesized that cationic airway lining modulators will have beneficial effects on the rheological properties of sputum derived from patients with COPD. Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be collected and tested in laboratory tests.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Sputum, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The VA Western New York Healthcare System, Buffalo Institute For Medical Research
- Investigators
- Sanjay Sethi, MD, Principal investigator, Va Western NY Healthcare, Buffalo Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096173
- Sponsor's protocol ID
- PUL_VABUF_01
- Status last verified
- Apr 2011
- First submitted
- 25 Mar 2010
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the in Vitro Effects of CALM on COPD Sputum
- ClinicalTrials.gov ID
- NCT01096173
- Acronym / sponsor ID
- PUL_VABUF_01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Sputum, chronic obstructive pulmonary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Collaborators
- The VA Western New York Healthcare System, Buffalo Institute For Medical Research
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Mar 2010 (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 intended to be an evaluation of the properties of human sputum collected from patients with COPD. It is hypothesized that cationic airway lining modulators will have beneficial effects on the rheological properties of sputum derived from patients with COPD. Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be collected and tested in laboratory tests.
Study design
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic setting
Key inclusion criteria (3 listed)
- Clinical and spirometric diagnosis of COPD
- Smoking history of at least 10 pack yrs
- Sputum production of greater than 2 tablespoons per day by patient report.
Key exclusion criteria (3 listed)
- a primary diagnosis of asthma or bronchiectasis
- a COPD exacerbation within 4 weeks
- Inability to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 11 Apr 2011.
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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.
Sanjay Sethi, MD principal investigator
Va Western NY Healthcare, Buffalo Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Pulmatrix 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 3 inclusion and 3 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 11 Apr 2011. 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 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 11 Apr 2011.