Chronic Obstructive Airway DiseasePhase 4NCT01555593
Effect of Prolonged Decubitus on Nitric Oxide Concentration in Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Cardioline Exp'air by Medi-soft - Sorinnes (B) in people with Chronic Obstructive Airway Disease, run by University of Milan at 1 site in Italy.
Trial summary
Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is caused by inflammation of peripheral airways walls. Neutrophils and other inflammatory mediators Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor alfa (TNF-alfa)… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Obstructive Airway Disease
- What is being tested?
- Cardioline Exp'air by Medi-soft - Sorinnes (B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to May 2014
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of informed consent
- COPD patients with age raging from 50 to 85 years old
- Patients with at least a history of COPD of one year
- COPD patients clinically stable in the last three months
- COPD subjects with FEV1<70% of predicted value
- FEV1/FVC <88% (males) or <89% (females) of LLN
- COPD former or active smokers with at least a smoking history of 20 pack year
Who cannot join
- Acute Bronchial Exacerbation at recruitment
- Fertile women with age between 18 and 50 years old or with active period
- Pregnancy
- Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment.
- FEV1/FVC more than 70% of predicted value in basal conditions
- FEV1 more than 70% of predicted value in basal conditions
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- Known deficit of alpha 1 antitrypsin
- Subjects that underwent a Lung Volume Reduction Surgery (LVRS)
- Subjects with known positivity to Human Immunodeficiency Virus (HIV)
- Misuse of alcool or drugs
- Lack of compliance in performing respiratory tests
- Subjects not capable to follow the study prescriptions because of psychic disorders or language problems.
- Long Term Oxygen Therapy with flows > 6 litres per minute (l/min) at rest
Trial locations and contacts
1 site in 1 country.
Italy1 site
: Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS
Milan, Milano
About this study
Official title: Effect of Prolonged Decubitus on Bronchial Inflammation in COPD Patients Evaluated by Expired NO Concentration Assessment
- Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is caused by inflammation of peripheral airways walls.
- Neutrophils and other inflammatory mediators Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric Oxyde (NO) are implicated in the inflammation.
- Exhaled NO concentration is usually used to monitor bronchial inflammation
- The relationship between decubitus and small airways behaviour is not well understood.
- Our hypothesis is that cyclic opening and closure of peripheral airways during decubitus can provoke an inflammatory response which can be monitored by exhaled NO.
- Data about these physiopathological aspects is missing in literature.
Read the detailed description
Bronchial inflammation in COPD represents one of the main causes of not fully reversible obstruction and airflow limitation. The main inflammatory cells involved are represented by the neutrophils, while some inflammatory mediators (IL6, IL8, IL1alpha, IL1beta, TNFalfa, ROS, LTB4, NO) provoke the disruption of the elastic alveolar bonds that support the small airways, thus invalidating their physical and mechanical characteristics. During decubitus, in such patients, the more dependent parts of the lung are subjected to gravity force, which together with chronic inflammation may cause, we suppose, one of the following effects during tidal breathing:
- a total closure of the smaller bronchioli
- a cyclic opening and closure of the small airways thus provoking friction and an inflammatory response of mechanical origin.
The Fraction of Exhaled Nitric Oxyde (FeNO) concentration is largely used in clinical practice as a marker to monitor the lung inflammatory status.
The purpose of the study is to evaluate the possible mechanical origin of the bronchial inflammation in correlation with prolonged supine decubitus, and so use the NO as an index of the small airways impairment in COPD patients.
To do this we will measure the exhaled NO concentration in COPD patients with moderate to severe obstruction, that is a Forced Expiratory Volume less than 70% of predicted value (FEV1<70%pred). The evaluation will be done in four different moments:
- before the patient goes to sleep while in supine position
- immediately after the patient wakes up in the morning, still being in supine position.
- while sitting on the bed after point 2
- in the morning after one hour of normal patient's activities, in seated position.
Together with NO concentration, also the Respiratory Frequency and Tidal Volume will be registered during each evaluation.
All the subjects will be inpatients accessing a respiratory rehabilitation unit. At the beginning and after 15 days of rehabilitation a functional respiratory assessment will be made (spirometry, plethysmography, Carbon Monoxide (CO) diffusion lung test), together with an arterial blood gas analysis and a 6 minutes walking test (WT6').
An initial and a final assessment of dyspnoea will be made by Borg and Modified Medical Research Council (mMRC) scales. For the study duration all the patients will continue their inhaled therapy as usual (an ultra long acting anticholinergic once daily plus a long acting Beta-2 agonist in combination with an inhaled corticosteroid twice daily)
- Conditions
- Chronic Obstructive Airway Disease
- Being tested
- Cardioline Exp'air by Medi-soft - Sorinnes (B)
- Keywords
- COPD, FeNO, Bronchial inflammation, Small airways, Decubitus
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioline Exp'air by Medi-soft - Sorinnes (B)Device
FeNO measurement in four different moments, the first in the evening, the last three in the morning of the day after. These evaluations will be repeated when the patient enters the unit and after 15 days of rehabilitation activity
| Study group | Role | What they receive |
|---|---|---|
| COPD FEV1<70%pred feNO Cardioline Exp'air | Experimental | COPD subjects with FEV1<70% of predicted value and Forced Expiratory Volume Forced to Forced Vital Capacity ratio (FEV1/FVC) less than 88% (males)or less than 89% (females) of Low Levels of Normality (LLN) entering the respiratory rehabilitation unit will undergo multiflow feNo measure with Cardioline Exp'air by Medi-soft - Sorinnes (B) Receives: Device: Cardioline Exp'air by Medi-soft - Sorinnes (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fraction of Exhaled Nitric Oxide related to patient's change of decubitus before and after a rehabilitation cycle
NO concentration will be evaluated in four different sessions at t0 and t1: 1) immediately after the patient goes to bed while he is in supine position; 2) when the patient wakes up, when he's still in the bed in supine position; 3) in sitted position after 5 deep inspirations to total lung capacity 4) after one hour of normal morning activity, again in sitted position. The NO measurements will be collected by a portable NO analyzer at the patient's bed.
Measured: The exhaled NO concentration will be assessed in two different moments: the day immediately after the hospitalization (t0) and after 15 days (t1) of rehabilitation activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri
- Responsible party
- Principal investigator, Pierachille Santus, University of Milan
- Investigators
- Pierachille Santus, Md, PhD, Study director, Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555593
- Sponsor's protocol ID
- 630CEC
- Status last verified
- Oct 2014
- First submitted
- 9 Mar 2012
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Decubitus on Bronchial Inflammation in COPD Patients Evaluated by Expired NO Concentration Assessment
- ClinicalTrials.gov ID
- NCT01555593
- Acronym / sponsor ID
- 630CEC
- Conditions
- Chronic Obstructive Airway Disease
- Keywords
- COPD, FeNO, Bronchial inflammation, Small airways, Decubitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Mar 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.
- Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is caused by inflammation of peripheral airways walls.
- Neutrophils and other inflammatory mediators Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric Oxyde (NO) are implicated in the inflammation.
- Exhaled NO concentration is usually used to monitor bronchial inflammation
- The relationship between decubitus and small airways behaviour is not well understood.
- Our hypothesis is that cyclic opening and closure of peripheral airways during decubitus can provoke an inflammatory response which can be monitored by exhaled NO.
- Data about these physiopathological aspects is missing in literature.
Detailed description
Bronchial inflammation in COPD represents one of the main causes of not fully reversible obstruction and airflow limitation. The main inflammatory cells involved are represented by the neutrophils, while some inflammatory mediators (IL6, IL8, IL1alpha, IL1beta, TNFalfa, ROS, LTB4, NO) provoke the disruption of the elastic alveolar bonds that support the small airways, thus invalidating their physical and mechanical characteristics. During decubitus, in such patients, the more dependent parts of the lung are subjected to gravity force, which together with chronic inflammation may cause, we suppose, one of the following effects during tidal breathing:
- a total closure of the smaller bronchioli
- a cyclic opening and closure of the small airways thus provoking friction and an inflammatory response of mechanical origin.
The Fraction of Exhaled Nitric Oxyde (FeNO) concentration is largely used in clinical practice as a marker to monitor the lung inflammatory status.
The purpose of the study is to evaluate the possible mechanical origin of the bronchial inflammation in correlation with prolonged supine decubitus, and so use the NO as an index of the small airways impairment in COPD patients.
To do this we will measure the exhaled NO concentration in COPD patients with moderate to severe obstruction, that is a Forced Expiratory Volume less than 70% of predicted value (FEV1<70%pred). The evaluation will be done in four different moments:
- before the patient goes to sleep while in supine position
- immediately after the patient wakes up in the morning, still being in supine position.
- while sitting on the bed after point 2
- in the morning after one hour of normal patient's activities, in seated position.
Together with NO concentration, also the Respiratory Frequency and Tidal Volume will be registered during each evaluation.
All the subjects will be inpatients accessing a respiratory rehabilitation unit. At the beginning and after 15 days of rehabilitation a functional respiratory assessment will be made (spirometry, plethysmography, Carbon Monoxide (CO) diffusion lung test), together with an arterial blood gas analysis and a 6 minutes walking test (WT6').
An initial and a final assessment of dyspnoea will be made by Borg and Modified Medical Research Council (mMRC) scales. For the study duration all the patients will continue their inhaled therapy as usual (an ultra long acting anticholinergic once daily plus a long acting Beta-2 agonist in combination with an inhaled corticosteroid twice daily)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD FEV1<70%pred feNO Cardioline Exp'air | Experimental | Device: Cardioline Exp'air by Medi-soft - Sorinnes (B)COPD subjects with FEV1<70% of predicted value and Forced Expiratory Volume Forced to Forced Vital Capacity ratio (FEV1/FVC) less than 88% (males)or less than 89% (females) of Low Levels of Normality (LLN) entering the respiratory rehabilitation unit will undergo multiflow feNo measure with Cardioline Exp'air by Medi-soft - Sorinnes (B) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signature of informed consent
- COPD patients with age raging from 50 to 85 years old
- Patients with at least a history of COPD of one year
- COPD patients clinically stable in the last three months
- COPD subjects with FEV1<70% of predicted value
Key exclusion criteria (13 listed)
- Acute Bronchial Exacerbation at recruitment
- Fertile women with age between 18 and 50 years old or with active period
- Pregnancy
- Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment.
- FEV1/FVC more than 70% of predicted value in basal conditions
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 |
|---|---|---|
| Cardioline Exp'air by Medi-soft - Sorinnes (B)FeNO measurement in four different moments, the first in the evening, the last three in the morning of the day after. These evaluations will be repeated when the patient enters the unit and after 15 days of rehabilitation activity | Device | COPD FEV1<70%pred feNO Cardioline Exp'air |
Primary outcome
Change of Fraction of Exhaled Nitric Oxide related to patient's change of decubitus before and after a rehabilitation cycle
Time frame: The exhaled NO concentration will be assessed in two different moments: the day immediately after the hospitalization (t0) and after 15 days (t1) of rehabilitation activity
NO concentration will be evaluated in four different sessions at t0 and t1: 1) immediately after the patient goes to bed while he is in supine position; 2) when the patient wakes up, when he's still in the bed in supine position; 3) in sitted position after 5 deep inspirations to total lung capacity 4) after one hour of normal morning activity, again in sitted position. The NO measurements will be collected by a portable NO analyzer at the patient's bed.
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 29 Oct 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.
Pierachille Santus, Md, PhD study director
Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO
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 Cardioline Exp'air by Medi-soft - Sorinnes (B) in people with Chronic Obstructive Airway Disease, run by University of Milan at 1 site in Italy.
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 7 inclusion and 13 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 29 Oct 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 Italy. 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?
Change of Fraction of Exhaled Nitric Oxide related to patient's change of decubitus before and after a rehabilitation cycle (time frame: The exhaled NO concentration will be assessed in two different moments: the day immediately after the hospitalization (t0) and after 15 days (t1) of rehabilitation activity). 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 Oct 2014.