COPDPhase 2PIF3NCT02018549
An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler DPI
A Phase 2 study testing Inhalation through Chiesi NEXThaler DPI in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial summary
Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler device in adult COPD patients with varying degrees of airflow limitation Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Inhalation through Chiesi NEXThaler DPI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the patient and/or the legal representatives
- Inpatients and outpatients of both sexes, aged ≥ 40 years
- Documented clinical diagnosis (within the past 6 months) of COPD with varying degrees of airflow limitation based on Spirometric classification of disease severity according to GOLD 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). Current smokers and ex-smokers are eligible
- A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler® as confirmed by the activation of the training device BAM
Who cannot join
- Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable)
- Diagnosis of asthma
- Diagnosis of restrictive lung disease
- Allergy to any component of the placebo treatment
- Inability to comply with study procedures or treatment
- Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any previously documented laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler Dry Powder Inhaler (DPI) Device
Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler device in adult COPD patients with varying degrees of airflow limitation
Read the detailed description
As this is an exploratory study, a total of 70 to 80 completed patients, ensuring the following distribution in terms of COPD Stage as per GOLD 2013 (updated) spirometric classification of disease severity, are deemed to be sufficient for assessing the inhalation profile through the NEXThaler®:
- 10 to 20 COPD GOLD Stage I patients
- 20 patients in each of the COPD GOLD Stage II to IV. Assuming a screening failure/drop-out rate of 10%, a maximum of 89 patients will be screened in order to reach the required number of completed patients.
All the analyses will be performed separately for the first and the second inhalation. Results stratified by disease severity and overall will be presented.
- Conditions
- COPD
- Being tested
- Inhalation through Chiesi NEXThaler DPI
- Keywords
- COPD, placebo, inhalatory profile
- 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.
Inhalation through Chiesi NEXThaler DPIDevice
Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Inhalation through Chiesi NEXThaler DPI containing Placebo Dry Powder. Each patient will perform at least two inhalations using the Chiesi NEXThaler DPI device containing placebo dry powder. There is no comparator and all patients will receive the same study treatment. Receives: Device: Inhalation through Chiesi NEXThaler DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Inhalatory Profile for 80 patients
The study duration per patient is only one visit. At visit 1 the patient after having signed the ICF and after having assessed the eligibility criteria should perform two evaluable inhalatory manoeuvres through the device instrumented with an acoustic monitoring system (microphone). The sounds captured by the microphone are sent to a PC which acquire it for analysis of the profile. Each manoeuvre lasts few seconds. After having completed the manoeuvres and have the same assessed as good by the Investigator, the study is completed. All the procedures are expected to be performed within a couple of hours for each patient.
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Scuri, MD, Study director, Chiesi Farmaceutici S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018549
- Sponsor's protocol ID
- CCD_01535BC1_01
- Other IDs
- 2013-000262-11
- Acronym
- PIF3
- Status last verified
- Oct 2021
- First submitted
- 3 Jul 2013
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler Dry Powder Inhaler (DPI) Device
- ClinicalTrials.gov ID
- NCT02018549
- Acronym / sponsor ID
- PIF3 / CCD_01535BC1_01
- Conditions
- COPD
- Keywords
- COPD, placebo, inhalatory profile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Dec 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.
Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler device in adult COPD patients with varying degrees of airflow limitation
Detailed description
As this is an exploratory study, a total of 70 to 80 completed patients, ensuring the following distribution in terms of COPD Stage as per GOLD 2013 (updated) spirometric classification of disease severity, are deemed to be sufficient for assessing the inhalation profile through the NEXThaler®:
- 10 to 20 COPD GOLD Stage I patients
- 20 patients in each of the COPD GOLD Stage II to IV. Assuming a screening failure/drop-out rate of 10%, a maximum of 89 patients will be screened in order to reach the required number of completed patients.
All the analyses will be performed separately for the first and the second inhalation. Results stratified by disease severity and overall will be presented.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Device: Inhalation through Chiesi NEXThaler DPIInhalation through Chiesi NEXThaler DPI containing Placebo Dry Powder. Each patient will perform at least two inhalations using the Chiesi NEXThaler DPI device containing placebo dry powder. There is no comparator and all patients will receive the same study treatment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent obtained from the patient and/or the legal representatives
- Inpatients and outpatients of both sexes, aged ≥ 40 years
- Documented clinical diagnosis (within the past 6 months) of COPD with varying degrees of airflow limitation based on Spirometric classification of disease severity according to GOLD 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). Current smokers and ex-smokers are eligible
- A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler® as confirmed by the activation of the training device BAM
Key exclusion criteria (6 listed)
- Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable)
- Diagnosis of asthma
- Diagnosis of restrictive lung disease
- Allergy to any component of the placebo treatment
- Inability to comply with study procedures or treatment
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 |
|---|---|---|
| Inhalation through Chiesi NEXThaler DPIInhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set | Device | Placebo |
Primary outcome
Evaluation of Inhalatory Profile for 80 patients
Time frame: Visit 1
The study duration per patient is only one visit. At visit 1 the patient after having signed the ICF and after having assessed the eligibility criteria should perform two evaluable inhalatory manoeuvres through the device instrumented with an acoustic monitoring system (microphone). The sounds captured by the microphone are sent to a PC which acquire it for analysis of the profile. Each manoeuvre lasts few seconds. After having completed the manoeuvres and have the same assessed as good by the Investigator, the study is completed. All the procedures are expected to be performed within a couple of hours for each patient.
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 2021.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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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.
Mario Scuri, MD study director
Chiesi Farmaceutici S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhalation through Chiesi NEXThaler DPI in people with COPD, run by Chiesi Farmaceutici S.p.A. 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 4 inclusion and 6 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 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation of Inhalatory Profile for 80 patients (time frame: Visit 1). 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 2021; AzTrials last refreshed its copy on 6 Nov 2026.