Cystic FibrosisSPICyNCT03760120
Short-term Effects of Physiotherapy on LCI
A study testing PEP-MASK in people with Cystic Fibrosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
Trial summary
Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- PEP-MASK
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesItaly
- Study dates
- 21 Nov 2016to Dec 2022
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CF diagnosis
- Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre
- ≥ 15 kilograms
- FEV1 ≥ 40%predicted
- Ability to perform NMBW test
- Ability to perform spirometry
- Willing to adhere to protocol procedures
- Patients in treatment with PEP-MASK
Who cannot join
- Pulmonary Exacerbation within two last week
- Burkholderia cepacia infection
- Patients in lung transplantation waiting list
- Patients undergoing non invasive mechanical ventilation or oxygen therapy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliero-Universitaria Meyer
Florence
Centro Regionale di Riferimento Fibrosi Cistica
Milan
About this study
Official title: Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis
Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).
The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).
Read the detailed description
Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.
Standard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity.
Sample size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.
- Conditions
- Cystic Fibrosis
- Being tested
- PEP-MASK
- Keywords
- physiotherapy, pulmonary function
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-MASKDevice
| Study group | Role | What they receive |
|---|---|---|
| PEP standard | Active comparator | Not described Receives: Device: PEP-MASK |
| PEP sham | Sham comparator | Not described Receives: Device: PEP-MASK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of PEP-MASK on ventilation heterogeneity (Sacin)
Acinar airways (Sacin) mean difference between treatments
Measured: Right after intervention/sham procedure
Secondary outcomes (4)
Effect of PEP-MASK on ventilation heterogeneity (Scond)
Conductive airways (Scond) mean difference between treatments
Measured: Right after intervention/sham procedure
Effect of PEP-MASK on ventilation heterogeneity (LCI)
Ventilation heterogeneity (LCI) mean difference between treatments
Measured: Right after intervention/sham procedure
Sputum weight
Sputum weight (grams) will be collected throughout the active or sham interventions
Measured: From the beginning to the end of each intervention/sham procedure
Oxygen saturation
Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions
Measured: From the beginning to the end of each intervention/sham procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start21 Nov 2016
- Primary completionAug 2022
- Study completionDec 2022
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 Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla Colombo, Study director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760120
- Sponsor's protocol ID
- 2291
- Acronym
- SPICy
- Status last verified
- Dec 2022
- First submitted
- 7 Nov 2018
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03760120
- Acronym / sponsor ID
- SPICy / 2291
- Conditions
- Cystic Fibrosis
- Keywords
- physiotherapy, pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 30 Nov 2018 (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.
Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).
The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).
Detailed description
Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.
Standard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity.
Sample size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.
| Arm | Type | Receives |
|---|---|---|
| PEP standard | Active comparator | Device: PEP-MASK |
| PEP sham | Sham comparator | Device: PEP-MASK |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- CF diagnosis
- Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre
- ≥ 15 kilograms
- FEV1 ≥ 40%predicted
- Ability to perform NMBW test
Key exclusion criteria (4 listed)
- Pulmonary Exacerbation within two last week
- Burkholderia cepacia infection
- Patients in lung transplantation waiting list
- Patients undergoing non invasive mechanical ventilation or oxygen therapy
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 |
|---|---|---|
| PEP-MASK | Device | PEP sham, PEP standard |
Primary outcome
Effect of PEP-MASK on ventilation heterogeneity (Sacin)
Time frame: Right after intervention/sham procedure
Acinar airways (Sacin) mean difference between treatments
4 secondary outcomes
Effect of PEP-MASK on ventilation heterogeneity (Scond)
Time frame: Right after intervention/sham procedure
Effect of PEP-MASK on ventilation heterogeneity (LCI)
Time frame: Right after intervention/sham procedure
Sputum weight
Time frame: From the beginning to the end of each intervention/sham procedure
Oxygen saturation
Time frame: From the beginning to the end of each intervention/sham procedure
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 Dec 2022.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Standard Operating Procedures LCILink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Carla Colombo study director
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP-MASK in people with Cystic Fibrosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 8 inclusion and 4 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 Dec 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Effect of PEP-MASK on ventilation heterogeneity (Sacin) (time frame: Right after intervention/sham procedure). 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 NCT03760120, 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 Dec 2022.