Cystic FibrosisNCT02303808
Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis
A study testing INHALATION WITH PEP DEVICE (Acapella Duet) in people with Cystic Fibrosis, run by Universidad San Jorge at 1 site in Spain.
Trial summary
This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- INHALATION WITH PEP DEVICE (Acapella Duet)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2014to Nov 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pass the inhalation test
- Chronic sputum production, at least ≥ 10 ml /24h
- Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l)
- Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
- Trained in the use of autogenic drainage technique (at least 6 months)
- Inhaling hypertonic saline since at least 6 months
- To be able to provide written, informed consent and perform the protocol and the evaluations
Who cannot join
- Active massive hemoptysis during the previous 2 months
- Patient in transplantation or retransplantation list
- Patient already participating in another study at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).
Read the detailed description
All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.
During the study period the patients' pharmacological treatment remains unchanged
- Conditions
- Cystic Fibrosis
- Being tested
- INHALATION WITH PEP DEVICE (Acapella Duet)
- Keywords
- Hyperosmolar agents, Hypertonic saline, Airway clearance techniques, Positive Expiratory Pressure, Autogenic drainage
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INHALATION WITH PEP DEVICE (Acapella Duet)Device
Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| USUAL CARE | No intervention | Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. |
| INHALATION WITH PEP DEVICE | Active comparator | Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. Receives: Device: INHALATION WITH PEP DEVICE (Acapella Duet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet sputum production
Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)
Measured: 45 minutes
Secondary outcomes (6)
Wet sputum production
2 hours wet sputum production (ml) after chest physiotherapy session
Measured: 2 hours
Wet sputum production
22 hours wet sputum production (ml) after chest physiotherapy session
Measured: 22 hours
Lung function (simply spirometry)
Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Measured: 5 days
Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)
Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate
Measured: 45 minutes
Patient's perception (Likert test)
Likert test
Measured: 5 days
Questionnaire
Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C\&S)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta San Miguel, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303808
- Sponsor's protocol ID
- FQ_INH_PEP_01
- Other IDs
- 239|2012
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.
PubMed 37319354San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.
PubMed 32026826
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT02303808
- Acronym / sponsor ID
- FQ_INH_PEP_01
- Conditions
- Cystic Fibrosis
- Keywords
- Hyperosmolar agents, Hypertonic saline, Airway clearance techniques, Positive Expiratory Pressure, Autogenic drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Dec 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.
This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).
Detailed description
All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.
During the study period the patients' pharmacological treatment remains unchanged
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| USUAL CARE | No intervention | –Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. |
| INHALATION WITH PEP DEVICE | Active comparator | Device: INHALATION WITH PEP DEVICE (Acapella Duet)Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pass the inhalation test
- Chronic sputum production, at least ≥ 10 ml /24h
- Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l)
- Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
- Trained in the use of autogenic drainage technique (at least 6 months)
Key exclusion criteria (3 listed)
- Active massive hemoptysis during the previous 2 months
- Patient in transplantation or retransplantation list
- Patient already participating in another study at the same time
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 WITH PEP DEVICE (Acapella Duet)Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized. | Device | INHALATION WITH PEP DEVICE |
Primary outcome
Wet sputum production
Time frame: 45 minutes
Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)
6 secondary outcomes
Wet sputum production
Time frame: 2 hours
Wet sputum production
Time frame: 22 hours
Lung function (simply spirometry)
Time frame: 5 days
Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)
Time frame: 45 minutes
Patient's perception (Likert test)
Time frame: 5 days
Questionnaire
Time frame: 5 days
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 2 Dec 2015.
- Derived from this study: PubMed 37319354Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.
- Derived from this study: PubMed 32026826San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.
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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.
Marta San Miguel principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INHALATION WITH PEP DEVICE (Acapella Duet) in people with Cystic Fibrosis, run by Universidad San Jorge at 1 site in Spain.
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 3 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 2 Dec 2015. 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 Spain. 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.
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?
Wet sputum production (time frame: 45 minutes). 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 NCT02303808, which also lists 2 linked publications.
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 2 Dec 2015.