Chronic Obstructive Pulmonary Disease (COPD)Phase 4SANOBNCT01853787
Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients - SANOB Study
A Phase 4 study testing Formoterol Fumarate and Salmeterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Milan at 2 sites in Italy.
Trial summary
Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is also caused by inflammation of peripheral airways walls. Neutrophils and other inflammatory mediators like Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Formoterol Fumarate and Salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2014to Jun 2015
- 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 45 to 90 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 (Forced Expiratory Volume in 1st second)<70% of predicted value
- FEV1/FVC (Forced Expiratory Volume in 1st second/Forced Vital Capacity) <88% (males) or <89% (females) of LLN (Low Levels of Normality)
- 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
Show all 13Show fewer
- 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
2 sites in 1 country.
Italy2 sites
Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Scienze Mediche, Università di Ferrara
Ferrara, Ferrara, 44121
: Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS
Milan, Milano, 20138
About this study
Official title: Acute Bronchodilation and Bronchial Inflammation: Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients. Stretching of Airways and Nitric Oxide in Bronchodilation, SANOB Study
- Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is also caused by inflammation of peripheral airways walls.
- Neutrophils and other inflammatory mediators like 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.
- NO is produced in response to physical and chemical stress on bronchial epithelium and plays a critical role in small airways remodelling
- Exhaled NO concentration is usually used to monitor bronchial inflammation
- The relationship between stretch and strain of small airways and bronchial inflammation is not well understood.
- The investigators hypothesis is that cyclic opening and closure of peripheral obstructed airways through the consequent stretching and strain acting on them can provoke an inflammatory response which can be monitored by exhaled NO.
- The pharmacological effects of bronchodilators may play a role on bronchial inflammation by reducing the stretching stress on bronchiolar walls thus reducing the production of NO in exhalate
- 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 like Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL1alpha), Interleukin-1 beta (IL1beta), Tumor Necrosis Factor alfa (TNFalfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4) and Nitric Oxide (NO) provoke the disruption of the elastic alveolar bonds that support the small airways, thus invalidating their physical and mechanical characteristics. During tidal volume respiration, in such patients, the chronically obstructed small airways are subjected, the investigators suppose, to one of the following effects:
- a total closure of the smaller bronchioli causing atelectasis
- a cyclic opening and closure of the airways thus provoking friction and strain stress 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. Formoterol and Salmeterol are two of the most used Long Acting Beta 2 Agonists (LABA) for inhaled therapy of COPD, representing the basis of the bronchodilator therapy in this disease.
The purpose of the study is to evaluate the possible mechanical origin of the bronchial inflammation and then the capacity of inhaled LABA in acute conditions to modify the trend of production of NO by reducing stretching and strain forces. Thus the possible decline of exhaled NO concentration will be used as an index of the small airways inflammatory state occurring after inhaled therapy.
To do this the investigators 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:
- at baseline, after 72 hours of pharmacological washout conditions
- at 30 minutes after the assumption of inhaled therapy (Salmeterol 50 mcg or Formoterol 12 mcg in double blind conditions)
- at 60 minutes after step 2
- at 180 minutes after step 2 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 or outpatients of the ambulatory service. After every NO measure, a functional respiratory assessment will be made (spirometry, plethysmography, Carbon Monoxide (CO) diffusion lung test, Single Breath N2 washout test), together with an arterial blood gas analysis.
At every step a dyspnoea assessment will be made by Visual Analogic Scale, while Modified Medical Research Council (mMRC) scale will be assessed at the beginning of the test.
Every patient will repeat the four step assessment after 72 hours, while a double blind pharmacological crossover will be performed, thus creating a controlled study in witch every patients, at the end of the study, will take Salmeterol and Formoterol in a randomized way.
For the study duration all the patients will perform a pharmacological washout (living the short acting inhaled Beta 2 agonists as rescue medication)
- Being tested
- Formoterol Fumarate, Salmeterol
- Keywords
- COPD, bronchial inflammation, NO concentration, small airways, LABA, Small Airways Stretching, Stretch and strain of small airways in COPD, Acute LABA effect on NO production, Pulmonary desufflation
- 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.
Formoterol FumarateDrug
Also called Foradil spray, Novartis Farma S.p.A.
Formoterol Fumarate, one inhalation of 12 mcg via MDI (Metered Dose Inhaler) Modulite will be taken in double blind randomized way immediately after T0 evaluation.
SalmeterolDrug
Also called Serevent, GlaxoSmithKline S.p.A.
Salmeterol 50 mcg via MDI (Metered Dose Inhaler), one inhalation only, immediately after T0 evaluation
| Study group | Role | What they receive |
|---|---|---|
| Formoterol Fumarate | Experimental | At study day n°1 the patients will be randomized to take either Salmeterol or Formoterol in a double blind way. Receives: Drug: Formoterol Fumarate; Drug: Salmeterol |
| Salmeterol | Active comparator | The second study arm represents the crossing over arm. Every patient, at study day number 2 will take a different medication (Salmeterol 50 mcg or Formoterol 12 mcg) from that taken at the study day n° 1. Receives: Drug: Formoterol Fumarate; Drug: Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exhaled Nitric Oxide concentration after Long acting Beta 2 Agonist assumption
The evaluation of exhaled Nitric Oxide concentration will be performed following the schedule below:
- at baseline (T0), after 72 hours of inhalatory therapy washout
- 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg)
- 60 minutes after T0 (T2)
- 180 minutes after T0 (T3) every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day.
The measurements of Exhaled NO will be performed by Medi-Soft Exp'air FeNo concentration sampling device, Sorinnes (Dinant) Belgium. At every step, will be performed 3 measurements at different flows (50 ml/sec, 100 ml/sec, 150 ml/sec and 350 ml/sec), for a total of 12 valid measurements for each step.
Alveolar NO and Bronchial Wall NO concentrations will be taken in consideration.
Measured: - At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Secondary outcomes (5)
Change in static plethysmographic volumes, assessment of desufflation and resistances after Long acting Beta 2 Agonist assumption and
The evaluation of pulmonary desufflation and pulmonary specific resistances (sRAW) will be performed with a plethysmographic maneuver for each of the following steps:
- at baseline (T0), after 72 hours of inhalatory therapy washout
- 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg)
- 60 minutes after T0 (T2)
- 180 minutes after T0 (T3) every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day.
The considered pulmonary volumes will be the Residual Volume and the Functional Residual Capacity, while Specific Resistances of AirWays (sRAW)will be evaluated using a Jaeger (Germany) plethysmographic cabin. At every step, 3 measurements will be performed, following the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines on pulmonary Function testing.
Measured: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Diffusion Lung Capacity for Carbon Monoxide (DLCO) and Alveolar Volume (VA) variation from baseline
The evaluation of DLCO and VA will be assessed performing the Single Breath method for each of the following steps:
- at baseline (T0), after 72 hours of inhalatory therapy washout
- 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg)
- 60 minutes after T0 (T2)
- 180 minutes after T0 (T3) Every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day.
DLCO and VA will be obtained using a Jaeger (Germany) pneumotachograph with an integrated gas analyzer, by means of a fixed gas mixture made as follows : 10% Helium, 6% Carbon Monoxide, 84% Nitrogen At every step 3 consecutive measurements will be performed, following the ATS/ERS guidelines on pulmonary Function testing.
Measured: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Modification of arterial gases concentration after bronchodilator therapy in acute conditions
An arterial blood sampling will be taken for each of the following steps:
- at baseline (T0), after 72 hours of inhalatory therapy washout
- 180 minutes after T0 (T3) Every patient will repeat the same two steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day.
Partial arterial pressure of Oxygen and Partial arterial pressure of Carbon Dioxide will be obtained using a arterial gas analyzer GEM Premier 3000
Measured: At baseline, after 180 minutes of LABA assumption
Closing Capacity variability from baseline at the Single Breath Nitrogen Washout test
The evaluation of the appearance of the CLosing Capacity (CC) will be assessed performing the Single Breath Nitrogen Washout test (SBN2 test) for each of the following steps:
- at baseline (T0), after 72 hours of inhalatory therapy washout
- 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg)
- 60 minutes after T0 (T2)
- 180 minutes after T0 (T3) Every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day.
The CC will be obtained using Vmax, Jaeger (Germany) pneumotachograph with an integrated gas analyzer. The parameters considered will be the phase III (alveolar phase) and the phase IV (Closing Capacity appearance) at the SBN2 test.
At every step 3 consecutive measurements will be performed, following the ATS/ERS guidelines on pulmonary function testing.
Measured: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Change from baseline in dyspnoea, evaluated with VAS (Visual Analogue Scale).
The evaluation of grade of dyspnea will assessed through the VAS scale for each of the following steps:
- at baseline (T0), after 72 hours of inhalatory therapy washout
- 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg)
- 60 minutes after T0 (T2)
- 180 minutes after T0 (T3) Every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day.
Measured: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri, Università degli Studi di Ferrara
- 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
- NCT01853787
- Sponsor's protocol ID
- 898CEC
- Acronym
- SANOB
- Status last verified
- Jul 2015
- First submitted
- 5 May 2013
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Santus P, Radovanovic D, Mascetti S, Pauletti A, Valenti V, Mantero M, Papi A, Contoli M. Effects of bronchodilation on biomarkers of peripheral airway inflammation in COPD. Pharmacol Res. 2018 Jul;133:160-169. doi: 10.1016/j.phrs.2018.05.010. Epub 2018 May 23.
PubMed 29775687
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Bronchodilation and Bronchial Inflammation: Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients. Stretching of Airways and Nitric Oxide in Bronchodilation, SANOB Study
- ClinicalTrials.gov ID
- NCT01853787
- Acronym / sponsor ID
- SANOB / 898CEC
- Keywords
- COPD, bronchial inflammation, NO concentration, small airways, LABA, Small Airways Stretching, Stretch and strain of small airways in COPD, Acute LABA effect on NO production
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri, Università degli Studi di Ferrara
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 May 2013 (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.
- Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is also caused by inflammation of peripheral airways walls.
- Neutrophils and other inflammatory mediators like 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.
- NO is produced in response to physical and chemical stress on bronchial epithelium and plays a critical role in small airways remodelling
- Exhaled NO concentration is usually used to monitor bronchial inflammation
- The relationship between stretch and strain of small airways and bronchial inflammation is not well understood.
- The investigators hypothesis is that cyclic opening and closure of peripheral obstructed airways through the consequent stretching and strain acting on them can provoke an inflammatory response which can be monitored by exhaled NO.
- The pharmacological effects of bronchodilators may play a role on bronchial inflammation by reducing the stretching stress on bronchiolar walls thus reducing the production of NO in exhalate
- 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 like Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL1alpha), Interleukin-1 beta (IL1beta), Tumor Necrosis Factor alfa (TNFalfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4) and Nitric Oxide (NO) provoke the disruption of the elastic alveolar bonds that support the small airways, thus invalidating their physical and mechanical characteristics. During tidal volume respiration, in such patients, the chronically obstructed small airways are subjected, the investigators suppose, to one of the following effects:
- a total closure of the smaller bronchioli causing atelectasis
- a cyclic opening and closure of the airways thus provoking friction and strain stress 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. Formoterol and Salmeterol are two of the most used Long Acting Beta 2 Agonists (LABA) for inhaled therapy of COPD, representing the basis of the bronchodilator therapy in this disease.
The purpose of the study is to evaluate the possible mechanical origin of the bronchial inflammation and then the capacity of inhaled LABA in acute conditions to modify the trend of production of NO by reducing stretching and strain forces. Thus the possible decline of exhaled NO concentration will be used as an index of the small airways inflammatory state occurring after inhaled therapy.
To do this the investigators 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:
- at baseline, after 72 hours of pharmacological washout conditions
- at 30 minutes after the assumption of inhaled therapy (Salmeterol 50 mcg or Formoterol 12 mcg in double blind conditions)
- at 60 minutes after step 2
- at 180 minutes after step 2 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 or outpatients of the ambulatory service. After every NO measure, a functional respiratory assessment will be made (spirometry, plethysmography, Carbon Monoxide (CO) diffusion lung test, Single Breath N2 washout test), together with an arterial blood gas analysis.
At every step a dyspnoea assessment will be made by Visual Analogic Scale, while Modified Medical Research Council (mMRC) scale will be assessed at the beginning of the test.
Every patient will repeat the four step assessment after 72 hours, while a double blind pharmacological crossover will be performed, thus creating a controlled study in witch every patients, at the end of the study, will take Salmeterol and Formoterol in a randomized way.
For the study duration all the patients will perform a pharmacological washout (living the short acting inhaled Beta 2 agonists as rescue medication)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formoterol Fumarate | Experimental | Drug: Formoterol Fumarate, Drug: SalmeterolAt study day n°1 the patients will be randomized to take either Salmeterol or Formoterol in a double blind way. |
| Salmeterol | Active comparator | Drug: Formoterol Fumarate, Drug: SalmeterolThe second study arm represents the crossing over arm. Every patient, at study day number 2 will take a different medication (Salmeterol 50 mcg or Formoterol 12 mcg) from that taken at the study day n° 1. |
Who may qualify
- Ages
- 45 to 90 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 (Forced Expiratory Volume in 1st second)<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 |
|---|---|---|
| Formoterol FumarateAlso: Foradil spray, Novartis Farma S.p.A.Formoterol Fumarate, one inhalation of 12 mcg via MDI (Metered Dose Inhaler) Modulite will be taken in double blind randomized way immediately after T0 evaluation. | Drug | Formoterol Fumarate, Salmeterol |
| SalmeterolAlso: Serevent, GlaxoSmithKline S.p.A.Salmeterol 50 mcg via MDI (Metered Dose Inhaler), one inhalation only, immediately after T0 evaluation | Drug | Formoterol Fumarate, Salmeterol |
Primary outcome
Change in exhaled Nitric Oxide concentration after Long acting Beta 2 Agonist assumption
Time frame: - At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
The evaluation of exhaled Nitric Oxide concentration will be performed following the schedule below: * at baseline (T0), after 72 hours of inhalatory therapy washout * 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg) * 60 minutes after T0 (T2) * 180 minutes after T0 (T3) every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day. The measurements of Exhaled NO will be performed by Medi-Soft Exp'air FeNo concentration sampling device, Sorinnes (Dinant) Belgium. At every step, will be performed 3 measurements at different flows (50 ml/sec, 100 ml/sec, 150 ml/sec and 350 ml/sec), for a total of 12 valid measurements for each step. Alveolar NO and Bronchial Wall NO concentrations will be taken in consideration.
5 secondary outcomes
Change in static plethysmographic volumes, assessment of desufflation and resistances after Long acting Beta 2 Agonist assumption and
Time frame: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Diffusion Lung Capacity for Carbon Monoxide (DLCO) and Alveolar Volume (VA) variation from baseline
Time frame: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Modification of arterial gases concentration after bronchodilator therapy in acute conditions
Time frame: At baseline, after 180 minutes of LABA assumption
Closing Capacity variability from baseline at the Single Breath Nitrogen Washout test
Time frame: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
Change from baseline in dyspnoea, evaluated with VAS (Visual Analogue Scale).
Time frame: At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption
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 Jul 2015.
- Derived from this study: PubMed 29775687Santus P, Radovanovic D, Mascetti S, Pauletti A, Valenti V, Mantero M, Papi A, Contoli M. Effects of bronchodilation on biomarkers of peripheral airway inflammation in COPD. Pharmacol Res. 2018 Jul;133:160-169. doi: 10.1016/j.phrs.2018.05.010. Epub 2018 May 23.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Formoterol Fumarate and Salmeterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Milan at 2 sites 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 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 in exhaled Nitric Oxide concentration after Long acting Beta 2 Agonist assumption (time frame: - At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01853787, which also lists 1 linked publication.
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 Jul 2015.