Chronic Obstructive Pulmonary Disease(COPD)NCT01661374
The Effect of Humidification on Mucus Rheology
An observational study of Chronic Obstructive Pulmonary Disease(COPD), run by Virginia Commonwealth University at 1 site in United States.
Trial summary
In this study the investigators will collect mucus from mechanical ventilated patients and patients with COPD to study the effect of temperature and humidity, on the biophysical properties of the airway mucus. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease(COPD)
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2014
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic,ICU, Pulmonary Clinic
Who may be able to join
- Any Subject Mechanically Ventilated and producing sputum.
- 40 to 90 years of age suffering from COPD
- History of mucus production
Who cannot join
- None
- COPD Group
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
In this study the investigators will collect mucus from mechanical ventilated patients and patients with COPD to study the effect of temperature and humidity, on the biophysical properties of the airway mucus. It is hypothesised that changes in inspired gas temperature and humidity (over time) may affect the biophysical properties of the airway mucus and reduce the airway's ability to clear mucus, resulting in deleterious clinical affects.
Read the detailed description
Expectorated sputum samples are collected and used to measure the biophysical properties of mucus secretions. The samples are later exposed to different temperatures and humidity levels during bench experiments.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically Ventilated | Not described | |
| Chronic obstructive pulmonary disease (COPD). | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Collection
Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of sputum.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease(COPD)Studies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Bruce K Rubin, MEngr, MD, MBA, FRCPC, Principal investigator, Virginia Commonwealth University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661374
- Sponsor's protocol ID
- HM14433
- Status last verified
- Dec 2014
- First submitted
- 6 Aug 2012
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Humidification on Mucus Rheology
- ClinicalTrials.gov ID
- NCT01661374
- Acronym / sponsor ID
- HM14433
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Aug 2012 (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.
In this study the investigators will collect mucus from mechanical ventilated patients and patients with COPD to study the effect of temperature and humidity, on the biophysical properties of the airway mucus. It is hypothesised that changes in inspired gas temperature and humidity (over time) may affect the biophysical properties of the airway mucus and reduce the airway's ability to clear mucus, resulting in deleterious clinical affects.
Detailed description
Expectorated sputum samples are collected and used to measure the biophysical properties of mucus secretions. The samples are later exposed to different temperatures and humidity levels during bench experiments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated | – | – |
| Chronic obstructive pulmonary disease (COPD). | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic,ICU, Pulmonary Clinic
Key inclusion criteria (3 listed)
- Any Subject Mechanically Ventilated and producing sputum.
- 40 to 90 years of age suffering from COPD
- History of mucus production
Key exclusion criteria (3 listed)
- None
- COPD Group
- None
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
Sputum Collection
Time frame: 10 minutes
Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of sputum.
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 10 Dec 2014.
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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.
Bruce K Rubin, MEngr, MD, MBA, FRCPC principal investigator
Virginia Commonwealth University School of Medicine
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(COPD), run by Virginia Commonwealth University 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 10 Dec 2014. 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.
What does the primary outcome measure?
Sputum Collection (time frame: 10 minutes). 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 10 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.