Chronic Obstructive Pulmonary DiseasePhase 4NCT02181023
Acute Effect of Aclidinium on Hyperinflation and Ventilation Inhomogeneity in Severe COPD Patients
A Phase 4 study testing Aclidinium Bromide and Glycopyrronium Bromide in people with Chronic Obstructive Pulmonary Disease, run by University of Milan at 1 site in Italy.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and flow limitation. These physiopathological modifications are secondary to loss of elastic recoil and bronchial obstruction due to emphysema. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aclidinium Bromide and Glycopyrronium Bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Oct 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 Forced Expiratory Volume at one second (FEV1)<50% of predicted value
- COPD subjects with Residual Volume (RV) >125% predicted value
- FEV1/Forced Vital Capacity (FVC) <88% (males) or <89% (females) of Low Levels of Normality (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.
About this study
Official title: Acute Effect of Aclidinium on Hyperinflation and Lung Volume Distribution in Severe COPD Patients
- Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and flow limitation. These physiopathological modifications are secondary to loss of elastic recoil and bronchial obstruction due to emphysema.
- The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and anticholinergics. The molecules of the latter classes can be characterized by short lasting action (few hours), long acting action (12 hours) or ultra long acting duration of action (24 hours).
- For years the only anticholinergic (or antimuscarinic) drug other than those used by aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice daily).
- The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume. The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase III
- For COPD patients, the most important characteristic for an inhalatory drug is a prompt action in order to give a quick relief from respiratory symptoms, in particular dyspnoea.
- The objective of this study is to study the acute action of glycopyrronium and aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung volume distribution and dyspnoea at rest in severe COPD patients.
- To our knowledge no study has explored these aspects before.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by progressive and evolutionary physiopathological changes that are responsible for the developing of respiratory symptoms, disability, poor quality of life and morbidity. These changes are secondary to parenchymal disruption and chronic bronchiolar inflammation in major part due to cigarette smoke.
Lung architectural derangement and loss of elastic recoil secondary to emphysema together with decreased internal bronchiolar lumen due to mucosal chronic inflammation are responsible for bronchial obstruction, flow limitation and lung hyperinflation. All these features bring to exertional dyspnoea, chronic cough and sputum and so decreased activeness in daily life activities.
The Single Breath Nitrogen Washout Test (SBN2) is one of the test that more adequately can catch the modifications of small airways and their premature collapse called closing volume (CV). Together with CV the test reflects pulmonary ventilation inhomogeneity through the slope of the so called phase III (a plateau line of nitrogen concentration that is steeper the bigger the ventilation inhomogeneity). In literature the effects of COPD inhalatory treatments on this modifications and on hyperinflation were until today poorly analysed. Recently some new anticholinergic molecules were developed, in particular Aclidinium Bromide and Glycopyrronium Bromide, and there is no trace of such evaluation in medical literature with those new inhalatory drugs.
The study of the acute effects of these drugs on lung mechanics are mandatory because the quicker the effects, the faster the patient's dyspnoea relief.
The study will comprise a first enrollment visit and then the suitable subjects will undergo a pharmacological washout of 72 hours from any inhalatory drug except from Salbutamol.
Then the patients will be randomised to be given Glycopyrronium Bromide 44 mcg (and matched Aclidinium Bromide 322 mcg placebo) or Aclidinium Bromide 322 mcg (and matched Glycopyrronium Bromide 44 mcg placebo) (Day 1) with a double dummy scheme.
At day 1 the pre-dose (baseline) evaluation consists of:
- body plethysmography (with residual volume and specific resistances evaluation),
- arterial blood gas analysis (partial pressure of oxygen and carbon dioxide evaluation),
- SBN2
- Visual Analogic Scale for Dyspnoea (VAS scale) evaluation
- Diffusion Lung Capacity for Carbon Monoxide with Single Breath method (DLCO). These tests will be repeated after 5, 15, 30, 60 and 180 minutes after study drug inhalation. DLCO and arterial blood gas analysis will be performed only at baseline and after 180 minutes after study drug inhalation.
After day 1 all the patients will undergo another period of inhalatory therapy washout of 72 hours (only rescue Salbutamol spray permitted).
After the second pharmacological washout the patients will undergo the crossing over. The ones who were given Aclidinium Bromide will assume Glycopyrronium Bromide and vice versa (Day 2) always in double dummy conditions.
At Day 2 all the patients will undergo the same evaluation as in day 1. At day 1 and day 2 the study drugs with the two different devices (active drug + placebo) will be given to the patients by medical personnel not involved in the performing of any of the tests of day 1 and 2, in order to maintain the double blind conditions.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Aclidinium Bromide, Glycopyrronium Bromide
- Keywords
- COPD, Hyperinflation, Aclidinium, Glycopyrronium, Volume distribution, Anticholinergic, Pharmacokinetics, Single Breath Nitrogen Test, Phase III
- 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.
Aclidinium BromideDrug
Also called Eklira Genuair (UK), Tudorza Pressair (US), Bretaris Genuair (EU)
Aclidinium Bromide 322 mcg inhalation powder via Genuair inhaler (Eklira) Product by Almirall, S.A. Ronda General Mitre, 151. ES-08022 Barcelona, Spain
Glycopyrronium BromideDrug
Also called Seebri Breezhaler
Glycopyrronium Bromide 44 mcg dry powder (capsules) inhaled via Breezehaler inhaler, Seebri - product by Novartis Europharm Limited - Wimblehurst Road, Horsham, West Sussex, RH12 5AB; United Kingdom
| Study group | Role | What they receive |
|---|---|---|
| Aclidinium - Glycopyrronium | Experimental | Patients will assume Aclidinium Bromide 322 dry powder by Genuair inhaler and Glycopyrronium 44 dry powder inhaler by Breezehaler inhaler (placebo) after 72 hours from inhalatory therapy washout (only short acting bronchodilators permitted). Then, after 72 hours of inhalatory drugs washout (only short acting bronchodilators permitted), they will receive Glycopyrronium Bromide 322 mcg via Breezehaler inhaler and Aclidinium Bromide 322 dry powder by Genuair inhaler (placebo). Receives: Drug: Aclidinium Bromide; Drug: Glycopyrronium Bromide |
| Glycopyrronium - Aclidinium | Experimental | Patients will assume Glycopyrronium Bromide 44 mcg dry powder by Breezehaler inhaler and Aclidinium Bromide 322 dry powder by Genuair inhaler (placebo) after 72 hours of inhalatory therapy washout (only short acting bronchodilators permitted). Then, after 72 hours of inhalatory drugs washout (only short acting bronchodilators permitted) they will receive Aclidinium Bromide 322 mcg via Genuair inhaler and Glycopyrronium Bromide 44 mcg dry powder by Breezehaler inhaler (placebo). Receives: Drug: Aclidinium Bromide; Drug: Glycopyrronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Volume Variation from baseline
Residual Volume is obtained by performing body plethysmography before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over
Measured: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Functional Residual Capacity variation from baseline
Functional Residual Capacity (plethysmographic Intra Thoracic Gas Volume - ITGV) is obtained by performing body plethysmography before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over
Measured: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Secondary outcomes (3)
Phase III slope variation from baseline
Phase III slope is measured from the Single Breath Nitrogen Washout curve. It is measured at baseline (before study drug administration, and after 5, 15, 30, 60 and 180 minutes after study drug administration. The same patient will perform the same evaluation after drug crossing over
Measured: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Visual Analogical Scale (VAS) for Dyspnoea at rest variation from baseline
Visual Analogical Scale (VAS) for Dyspnoea is obtained by asking the patients to evaluate the intensity of dyspnoea sensation at rest putting a sign in a scale that ranges from 0 to 10, being 10 the maximum dyspnoea discomfort and 0 the absence of dyspnoea sensation. The VAS scale will be performed before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over.
Measured: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Oxygen and Carbon Dioxide variation from baseline
Partial Pressure of Oxygen (PaO2) and Partial Pressure of Carbon Dioxide (PaCO2) are obtained from arterial blood gas analysis before study drug inhalation and 180 minutes after drug inhalation. Patients will undergo the same evaluation after drug crossing over
Measured: At baseline and 180 minutes after inhalation of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionOct 2014
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 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
- NCT02181023
- Sponsor's protocol ID
- 960CEC
- Status last verified
- Oct 2014
- First submitted
- 1 Jul 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Santus P, Radovanovic D, Di Marco F, Raccanelli R, Valenti V, Centanni S. Faster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover study. Pulm Pharmacol Ther. 2015 Dec;35:42-9. doi: 10.1016/j.pupt.2015.11.001. Epub 2015 Nov 6.
PubMed 26549785
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
- Acute Effect of Aclidinium on Hyperinflation and Lung Volume Distribution in Severe COPD Patients
- ClinicalTrials.gov ID
- NCT02181023
- Acronym / sponsor ID
- 960CEC
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Hyperinflation, Aclidinium, Glycopyrronium, Volume distribution, Anticholinergic, Pharmacokinetics, Single Breath Nitrogen Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Jul 2014 (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.
- Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and flow limitation. These physiopathological modifications are secondary to loss of elastic recoil and bronchial obstruction due to emphysema.
- The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and anticholinergics. The molecules of the latter classes can be characterized by short lasting action (few hours), long acting action (12 hours) or ultra long acting duration of action (24 hours).
- For years the only anticholinergic (or antimuscarinic) drug other than those used by aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice daily).
- The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume. The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase III
- For COPD patients, the most important characteristic for an inhalatory drug is a prompt action in order to give a quick relief from respiratory symptoms, in particular dyspnoea.
- The objective of this study is to study the acute action of glycopyrronium and aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung volume distribution and dyspnoea at rest in severe COPD patients.
- To our knowledge no study has explored these aspects before.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by progressive and evolutionary physiopathological changes that are responsible for the developing of respiratory symptoms, disability, poor quality of life and morbidity. These changes are secondary to parenchymal disruption and chronic bronchiolar inflammation in major part due to cigarette smoke.
Lung architectural derangement and loss of elastic recoil secondary to emphysema together with decreased internal bronchiolar lumen due to mucosal chronic inflammation are responsible for bronchial obstruction, flow limitation and lung hyperinflation. All these features bring to exertional dyspnoea, chronic cough and sputum and so decreased activeness in daily life activities.
The Single Breath Nitrogen Washout Test (SBN2) is one of the test that more adequately can catch the modifications of small airways and their premature collapse called closing volume (CV). Together with CV the test reflects pulmonary ventilation inhomogeneity through the slope of the so called phase III (a plateau line of nitrogen concentration that is steeper the bigger the ventilation inhomogeneity). In literature the effects of COPD inhalatory treatments on this modifications and on hyperinflation were until today poorly analysed. Recently some new anticholinergic molecules were developed, in particular Aclidinium Bromide and Glycopyrronium Bromide, and there is no trace of such evaluation in medical literature with those new inhalatory drugs.
The study of the acute effects of these drugs on lung mechanics are mandatory because the quicker the effects, the faster the patient's dyspnoea relief.
The study will comprise a first enrollment visit and then the suitable subjects will undergo a pharmacological washout of 72 hours from any inhalatory drug except from Salbutamol.
Then the patients will be randomised to be given Glycopyrronium Bromide 44 mcg (and matched Aclidinium Bromide 322 mcg placebo) or Aclidinium Bromide 322 mcg (and matched Glycopyrronium Bromide 44 mcg placebo) (Day 1) with a double dummy scheme.
At day 1 the pre-dose (baseline) evaluation consists of:
- body plethysmography (with residual volume and specific resistances evaluation),
- arterial blood gas analysis (partial pressure of oxygen and carbon dioxide evaluation),
- SBN2
- Visual Analogic Scale for Dyspnoea (VAS scale) evaluation
- Diffusion Lung Capacity for Carbon Monoxide with Single Breath method (DLCO). These tests will be repeated after 5, 15, 30, 60 and 180 minutes after study drug inhalation. DLCO and arterial blood gas analysis will be performed only at baseline and after 180 minutes after study drug inhalation.
After day 1 all the patients will undergo another period of inhalatory therapy washout of 72 hours (only rescue Salbutamol spray permitted).
After the second pharmacological washout the patients will undergo the crossing over. The ones who were given Aclidinium Bromide will assume Glycopyrronium Bromide and vice versa (Day 2) always in double dummy conditions.
At Day 2 all the patients will undergo the same evaluation as in day 1. At day 1 and day 2 the study drugs with the two different devices (active drug + placebo) will be given to the patients by medical personnel not involved in the performing of any of the tests of day 1 and 2, in order to maintain the double blind conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aclidinium - Glycopyrronium | Experimental | Drug: Aclidinium Bromide, Drug: Glycopyrronium BromidePatients will assume Aclidinium Bromide 322 dry powder by Genuair inhaler and Glycopyrronium 44 dry powder inhaler by Breezehaler inhaler (placebo) after 72 hours from inhalatory therapy washout (only short acting bronchodilators permitted). Then, after 72 hours of inhalatory drugs washout (only short acting bronchodilators permitted), they will receive Glycopyrronium Bromide 322 mcg via Breezehaler inhaler and Aclidinium Bromide 322 dry powder by Genuair inhaler (placebo). |
| Glycopyrronium - Aclidinium | Experimental | Drug: Aclidinium Bromide, Drug: Glycopyrronium BromidePatients will assume Glycopyrronium Bromide 44 mcg dry powder by Breezehaler inhaler and Aclidinium Bromide 322 dry powder by Genuair inhaler (placebo) after 72 hours of inhalatory therapy washout (only short acting bronchodilators permitted). Then, after 72 hours of inhalatory drugs washout (only short acting bronchodilators permitted) they will receive Aclidinium Bromide 322 mcg via Genuair inhaler and Glycopyrronium Bromide 44 mcg dry powder by Breezehaler inhaler (placebo). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 Forced Expiratory Volume at one second (FEV1)<50% 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 |
|---|---|---|
| Aclidinium BromideAlso: Eklira Genuair (UK), Tudorza Pressair (US), Bretaris Genuair (EU)Aclidinium Bromide 322 mcg inhalation powder via Genuair inhaler (Eklira) Product by Almirall, S.A. Ronda General Mitre, 151. ES-08022 Barcelona, Spain | Drug | Aclidinium - Glycopyrronium, Glycopyrronium - Aclidinium |
| Glycopyrronium BromideAlso: Seebri BreezhalerGlycopyrronium Bromide 44 mcg dry powder (capsules) inhaled via Breezehaler inhaler, Seebri - product by Novartis Europharm Limited - Wimblehurst Road, Horsham, West Sussex, RH12 5AB; United Kingdom | Drug | Aclidinium - Glycopyrronium, Glycopyrronium - Aclidinium |
Primary outcome
Residual Volume Variation from baseline
Time frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Residual Volume is obtained by performing body plethysmography before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over
Functional Residual Capacity variation from baseline
Time frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Functional Residual Capacity (plethysmographic Intra Thoracic Gas Volume - ITGV) is obtained by performing body plethysmography before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over
3 secondary outcomes
Phase III slope variation from baseline
Time frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Visual Analogical Scale (VAS) for Dyspnoea at rest variation from baseline
Time frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration
Oxygen and Carbon Dioxide variation from baseline
Time frame: At baseline and 180 minutes after inhalation of study drug
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.
- Derived from this study: PubMed 26549785Santus P, Radovanovic D, Di Marco F, Raccanelli R, Valenti V, Centanni S. Faster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover study. Pulm Pharmacol Ther. 2015 Dec;35:42-9. doi: 10.1016/j.pupt.2015.11.001. Epub 2015 Nov 6.
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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 Aclidinium Bromide and Glycopyrronium Bromide in people with Chronic Obstructive Pulmonary 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 8 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?
Residual Volume Variation from baseline (time frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration). 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?
On the ClinicalTrials.gov record for NCT02181023, 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 29 Oct 2014.