Chronic Obstructive Pulmonary DiseasePhase 4EDAINCT04238221
Effect of add-on Doxofylline on Lung Function in Stable COPD
A Phase 4 study testing Doxofylline in people with Chronic Obstructive Pulmonary Disease, run by University of Milan at 1 site in Italy.
Trial summary
It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Doxofylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2026to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis for at least 6 months, according to current European Respiratory Society guidelines
- baseline FEV1 ≤ 80% of predicted value
- active or former smokers with smoking history ≥ 10 pack-years
- patients chronically treated with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonists (LABA), in association with or without an inhaled corticosteroid (ICS)
- clinically stable disease for 6 months.
Who cannot join
- previous or current diagnosis of bronchial asthma
- previous lung volume reduction through surgery or endobronchial valves
- inability to perform respiratory function tests according to international standards, or contraindications to perform 6-minute walking test
- known allergy or intolerance to doxofylline
- current or potential pregnancy
- mini-Mental test <21
Show all 14Show fewer
- congestive heart failure NYHA III or IV
- recent (<6 months) myocardial infarction
- unstable arrhythmias
- chronic hypotension
- active peptic ulcer
- severe liver disease
- active neoplasia
- history of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dejan Radovanovic, MD contact
Italy1 site
L. Sacco Hospital
Milan, 20157
Pierachille Santus, MD, PhD, 0239042801, pierachille.santus@unimi.it
About this study
Official title: Effect of Doxofylline on Bronchial Obstruction, in add-on to Maximal Inhalation Therapy, in Clinically Stable COPD Patients.
It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients.
Read the detailed description
The investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg, in add-on to maximal inhalation therapy (bronchodilators with or without a fixed dose combination with inhaled corticosteroids), in clinically stable COPD patients.
After screening and collection of informed consent, study participants will undergo a 7-day run-in, during which compliance to inhaled therapy and clinical stability will be assessed.
On the first visit patients will complete questionnaires (CAT, mMRC and SGRQ) to assess baseline respiratory function and health related quality of life.
After the first visit, patients will undergo a washout period during which the inhaled therapy will be withheld for 24 hours (7 days in case of chronic therapy with tiotropium).
The following day (the 8th day in case of tiotropium use), patients will perform the baseline measurement of the following:
- plethysmography
- DLCO
- maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
- 6-minute walk test (6MWT) with the assessment of dyspnea scale (Borg scale) at rest and after exercise.
Sixty minutes after the administration of the usual chronic inhalation therapy, patients will then perform the same respiratory lung functional bundle of tests as detailed above (from 1 to 3).
Subsequently, patients will be randomized in two parallel arms (arm A and arm B). Patients assigned to arm A will be prescribed 30-day treatment with doxofylline 400 mg bid, in addition to their chronic inhalation therapy, and will take the first dose of the medication; patients assigned to arm B will have their chronic therapy unchanged.
Randomization, drug administration and patient training will be performed by an operator not involved in patients' recruitment, data collection and analysis.
180 minutes after the administration of the usual chronic inhalation therapy, patients will repeat the lung function bundle from point 1 to 3.
During the subsequent 4-week treatment, patients' compliance will be monitored by telephone calls. Any adverse event will be registered and will be treated according to our center's standard operating procedures and good clinical practice by the treating physician.
After 4 weeks, before the administration of the morning dose, patients will be asked to complete the CAT, mMRC and SGRQ questionnaires and to perform the baseline functional bundle detailed in points 1 to 4. Patients will be asked to take the home inhalation therapy, as well as doxofylline if arm A. Respiratory function tests from points 1 to 3 will be repeated 60 minutes after drug administration. After that, patients assigned to Arm B will take the first dose of doxofylline. Respiratory function tests from points 1 to 3 will then be repeated 180 minutes after inhalation therapy administration. Eventually, the 6-MWT will be performed by patients assigned to Arm A, with assessment of the Borg dyspnea scale.
During the subsequent 4 weeks, patients assigned to arm B will be prescribed therapy with doxofylline 400 mg bid in addition to their chronic inhalatory therapy, while patients assigned to arm A will have only their usual chronic inhalation therapy. Compliance monitoring and adverse event management will be handled as previously discussed.
At the end of the 4 weeks, before the administration of the morning dose, patients will be asked to complete the CAT, mMRC and SGRQ questionnaires and to perform the baseline functional bundle detailed in points 1 to 4. Patients will be asked to take the home inhalation therapy, as well as doxofylline if arm B. Respiratory function tests from points 1 to 3 will be repeated 60 minutes and 180 minutes after drug administration. Eventually, the 6-MWT will be performed by patients assigned to Arm B, with assessment of the Borg dyspnea scale.
A 30-day follow up will be performed after the last visit, in order to register any late drug adverse reaction or adverse events..
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Doxofylline
- Keywords
- COPD, Bronchodilator, Pulmonary Function Test, Doxofylline, Methylxanthines, 6-minute walk test, FEV1
- 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.
DoxofyllineDrug
Also called Ansimar
Patients will receive a 4-week treatment with doxofylline 400 mg bid, in addition to their chronic usual inhalation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Doxofylline+inhalation therapy | Experimental | 4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy, followed by 4-week treatment of maximal inhalation therapy only Receives: Drug: Doxofylline |
| Inhalation therapy | Experimental | 4-week treatment with maximal inhalation therapy only, followed by 4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy Receives: Drug: Doxofylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in changes in FEV1 after 4 weeks of treatment
Difference between changes in the Forced Expiratory Volume in one second (FEV1) measured at baseline and the FEV1 after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the FEV1 measured at baseline and the FEV1 after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
Measured: 4-8 weeks
Secondary outcomes (13)
Change in FEV1 60' after drug administration
Changes in the Forced Expiratory Volume in one second (FEV1) measured at baseline and the FEV1 measured 60 minutes after the first dose of doxofylline plus inhalation therapy.
Measured: 60 minutes
Difference in changes in distance covered in 6-minute walking test after 4 weeks of treatment
Difference between changes in the distance covered in the 6-minute walking test (6-MWT) performed at baseline and the distance covered in 6-MWT performed after 4 weeks of treatment with doxofylline in addition to inhalation therapy, 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the distance covered in the 6-MWT performed at baseline and the 6-MWT performed after 4 weeks of treatment with inhalation therapy alone, 30 minutes before the morning dose of inhalation therapy.
Measured: 4-8 weeks
Changes in distance covered in 6-minute walking test 180' after drug administration
Change in the distance covered in the 6-minute walking test (6-MWT) performed at baseline and the distance covered in 6-MWT performed after 4 weeks of treatment with doxofylline in addition to inhalation therapy, 180 minutes after the morning dose of doxofylline
Measured: 4-8 weeks
Difference in changes in resting and effort dyspnea after 4 weeks of treatment
Difference between changes in the modified Borg dyspnea scale assessed before and after the 6-minute walking test (6-MWT) performed at baseline and the modified Borg dyspnea scale assessed before and after the 6-MWT performed after 4 weeks of treatment with doxofylline in addition to inhalation therapy, 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the modified Borg dyspnea scale assessed before and after the 6-MWT performed at baseline and the modified Borg dyspnea scale assessed before and after the 6-MWT performed after 4 weeks of treatment with inhalation therapy alone, 30 minutes before the morning dose of inhalation therapy.
Modified Borg dyspnea scale is used to rate difficulty of breathing and ranges from 0 (absence of dyspnea) to 10 (maximum dyspnea).
Measured: 4-8 weeks
Changes in resting and effort dyspnea 180' after drug administration
Difference between the modified Borg dyspnea scale assessed before and after the 6-minute walking test (6-MWT) performed at baseline and the modified Borg dyspnea scale assessed before and after the 6-MWT performed after 4 weeks of treatment with doxofylline in addition to inhalation therapy, 180 minutes after the morning dose of doxofylline plus inhalation therapy.
Modified Borg dyspnea scale is used to rate difficulty of breathing and ranges from 0 (absence of dyspnea) to 10 (maximum dyspnea).
Measured: 4-8 weeks
Difference in changes in modified Medical Research Council (mMRC) scale after 4 weeks of treatment
Difference between changes in the score of modified Medical Research Council (mMRC) scale at baseline and after 4 weeks of treatment with doxofylline in addition to chronic inhalation therapy and changes in the score of mMRC at baseline and after 4 weeks of treatment with chronic inhalation therapy alone.
The mMRC scale is used to assess the severity of dyspnea and ranges from 0 to 4; the higher the score, the higher the dyspnea sensation.
Measured: 4-8 weeks
Difference in changes in COPD Assessment Test (CAT) score after 4 weeks of treatment
Difference between changes in the score of COPD Assessment Test (CAT) at baseline and after 4 weeks of treatment with doxofylline in addition to chronic inhalation therapy and changes in the score of CAT at baseline and after 4 weeks of treatment with chronic inhalation therapy alone.
The CAT score is used to assess the impact of COPD on a patient's daily life, and ranges from 0 (suggesting no significant impact) to 40 (suggesting a very severe impact)
Measured: 4-8 weeks
Difference in changes in St. George Respiratory Questionnaire (SGRQ) after 4 weeks of treatment
Difference between changes in the score of St. George Respiratory Questionnaire (SGRQ) at baseline and the score of SGRQ after 4 weeks of treatment with doxofylline in addition to inhalation therapy and changes in the score of SGRQ at baseline and the SGRQ after 4 weeks of treatment with inhalation therapy alone.
SGRQ is designed to measure the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 4-8 weeks
Difference in changes in vital capacity after 4 weeks of treatment
Difference between changes in the slow vital capacity (VC) measured at baseline and the VC after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the VC measured at baseline and the VC after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
Measured: 4-8 weeks
Difference in changes in residual volume after 4 weeks of treatment
Difference between changes in the residual volume (RV) measured at baseline and the RV after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the RV measured at baseline and the RV after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
Measured: 4-8 weeks
Difference in changes in functional residual capacity after 4 weeks of treatment
Difference between changes in the functional residual capacity (FRC) measured at baseline and the FRC after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the FRC measured at baseline and the FRC after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
Measured: 4-8 weeks
Difference in changes in inspiratory capacity after 4 weeks of treatment
Difference between changes in the inspiratory capacity (IC) measured at baseline and the IC after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the IC measured at baseline and the IC after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
Measured: 4-8 weeks
Difference in changes in specific airway resistance after 4 weeks of treatment
Difference between changes in the specific airway resistances (sRaw) measured at baseline and the sRaw after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the sRaw measured at baseline and the sRaw after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Phase 4, single center, prospective, interventional, randomized, single blind, crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierachille Santus, MD, PhD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238221
- Sponsor's protocol ID
- 01-PNSNP-2020
- Acronym
- EDAI
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Doxofylline on Bronchial Obstruction, in add-on to Maximal Inhalation Therapy, in Clinically Stable COPD Patients.
- ClinicalTrials.gov ID
- NCT04238221
- Acronym / sponsor ID
- EDAI / 01-PNSNP-2020
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Bronchodilator, Pulmonary Function Test, Doxofylline, Methylxanthines, 6-minute walk test, FEV1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 23 Jan 2020 (actual)
- 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.
It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients.
Detailed description
The investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg, in add-on to maximal inhalation therapy (bronchodilators with or without a fixed dose combination with inhaled corticosteroids), in clinically stable COPD patients.
After screening and collection of informed consent, study participants will undergo a 7-day run-in, during which compliance to inhaled therapy and clinical stability will be assessed.
On the first visit patients will complete questionnaires (CAT, mMRC and SGRQ) to assess baseline respiratory function and health related quality of life.
After the first visit, patients will undergo a washout period during which the inhaled therapy will be withheld for 24 hours (7 days in case of chronic therapy with tiotropium).
The following day (the 8th day in case of tiotropium use), patients will perform the baseline measurement of the following:
- plethysmography
- DLCO
- maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
- 6-minute walk test (6MWT) with the assessment of dyspnea scale (Borg scale) at rest and after exercise.
Sixty minutes after the administration of the usual chronic inhalation therapy, patients will then perform the same respiratory lung functional bundle of tests as detailed above (from 1 to 3).
Subsequently, patients will be randomized in two parallel arms (arm A and arm B). Patients assigned to arm A will be prescribed 30-day treatment with doxofylline 400 mg bid, in addition to their chronic inhalation therapy, and will take the first dose of the medication; patients assigned to arm B will have their chronic therapy unchanged.
Randomization, drug administration and patient training will be performed by an operator not involved in patients' recruitment, data collection and analysis.
180 minutes after the administration of the usual chronic inhalation therapy, patients will repeat the lung function bundle from point 1 to 3.
During the subsequent 4-week treatment, patients' compliance will be monitored by telephone calls. Any adverse event will be registered and will be treated according to our center's standard operating procedures and good clinical practice by the treating physician.
After 4 weeks, before the administration of the morning dose, patients will be asked to complete the CAT, mMRC and SGRQ questionnaires and to perform the baseline functional bundle detailed in points 1 to 4. Patients will be asked to take the home inhalation therapy, as well as doxofylline if arm A. Respiratory function tests from points 1 to 3 will be repeated 60 minutes after drug administration. After that, patients assigned to Arm B will take the first dose of doxofylline. Respiratory function tests from points 1 to 3 will then be repeated 180 minutes after inhalation therapy administration. Eventually, the 6-MWT will be performed by patients assigned to Arm A, with assessment of the Borg dyspnea scale.
During the subsequent 4 weeks, patients assigned to arm B will be prescribed therapy with doxofylline 400 mg bid in addition to their chronic inhalatory therapy, while patients assigned to arm A will have only their usual chronic inhalation therapy. Compliance monitoring and adverse event management will be handled as previously discussed.
At the end of the 4 weeks, before the administration of the morning dose, patients will be asked to complete the CAT, mMRC and SGRQ questionnaires and to perform the baseline functional bundle detailed in points 1 to 4. Patients will be asked to take the home inhalation therapy, as well as doxofylline if arm B. Respiratory function tests from points 1 to 3 will be repeated 60 minutes and 180 minutes after drug administration. Eventually, the 6-MWT will be performed by patients assigned to Arm B, with assessment of the Borg dyspnea scale.
A 30-day follow up will be performed after the last visit, in order to register any late drug adverse reaction or adverse events..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 4, single center, prospective, interventional, randomized, single blind, crossover
| Arm | Type | Receives |
|---|---|---|
| Doxofylline+inhalation therapy | Experimental | Drug: Doxofylline4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy, followed by 4-week treatment of maximal inhalation therapy only |
| Inhalation therapy | Experimental | Drug: Doxofylline4-week treatment with maximal inhalation therapy only, followed by 4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD diagnosis for at least 6 months, according to current European Respiratory Society guidelines
- baseline FEV1 ≤ 80% of predicted value
- active or former smokers with smoking history ≥ 10 pack-years
- patients chronically treated with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonists (LABA), in association with or without an inhaled corticosteroid (ICS)
- clinically stable disease for 6 months.
Key exclusion criteria (14 listed)
- previous or current diagnosis of bronchial asthma
- previous lung volume reduction through surgery or endobronchial valves
- inability to perform respiratory function tests according to international standards, or contraindications to perform 6-minute walking test
- known allergy or intolerance to doxofylline
- current or potential pregnancy
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 |
|---|---|---|
| DoxofyllineAlso: AnsimarPatients will receive a 4-week treatment with doxofylline 400 mg bid, in addition to their chronic usual inhalation therapy. | Drug | Doxofylline+inhalation therapy, Inhalation therapy |
Primary outcome
Difference in changes in FEV1 after 4 weeks of treatment
Time frame: 4-8 weeks
Difference between changes in the Forced Expiratory Volume in one second (FEV1) measured at baseline and the FEV1 after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the FEV1 measured at baseline and the FEV1 after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
13 secondary outcomes
Change in FEV1 60' after drug administration
Time frame: 60 minutes
Difference in changes in distance covered in 6-minute walking test after 4 weeks of treatment
Time frame: 4-8 weeks
Changes in distance covered in 6-minute walking test 180' after drug administration
Time frame: 4-8 weeks
Difference in changes in resting and effort dyspnea after 4 weeks of treatment
Time frame: 4-8 weeks
Changes in resting and effort dyspnea 180' after drug administration
Time frame: 4-8 weeks
Difference in changes in modified Medical Research Council (mMRC) scale after 4 weeks of treatment
Time frame: 4-8 weeks
Difference in changes in COPD Assessment Test (CAT) score after 4 weeks of treatment
Time frame: 4-8 weeks
Difference in changes in St. George Respiratory Questionnaire (SGRQ) after 4 weeks of treatment
Time frame: 4-8 weeks
Difference in changes in vital capacity after 4 weeks of treatment
Time frame: 4-8 weeks
Difference in changes in residual volume after 4 weeks of treatment
Time frame: 4-8 weeks
Difference in changes in functional residual capacity after 4 weeks of treatment
Time frame: 4-8 weeks
Difference in changes in inspiratory capacity after 4 weeks of treatment
Time frame: 4-8 weeks
Difference in changes in specific airway resistance after 4 weeks of treatment
Time frame: 4-8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Dejan Radovanovic, MD contact
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 Doxofylline 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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierachille Santus, MD, PhD (0239043801, pierachille.santus@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in changes in FEV1 after 4 weeks of treatment (time frame: 4-8 weeks). 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 Apr 2026.