Cystic FibrosisNCT02261987
Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis
A study testing Autogenic drainage (AD), Resistive inspiratory manoeuvre (RIM) and Resistive inspiratory manoeuvre+autogenic drainage in people with Cystic Fibrosis, run by Universidad San Jorge at 4 sites in Spain.
Trial summary
This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable CF patients. 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?
- Autogenic drainage (AD), Resistive inspiratory manoeuvre (RIM) and Resistive inspiratory manoeuvre+autogenic drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesSpain
- Study dates
- Nov 2014to Jun 2016
- 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
- Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l)
- Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk);
- Chronic sputum production, at least ≥ 15 ml /24h
- Familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions)
- To be able to provide written, informed consent
Who cannot join
- Lung function: Forced expiratory volume in 1 second < 30 % pred . ; Forced vital capacity < 40 % pred.
- Active haemoptysis during the previous month
- Supplemental oxygen or non-invasive ventilation (NIV)
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Cystic Fibrosis Association
Madrid, Madrid
Cystic Fibrosis Association
Murcia, Murcia
Cystic Fibrosis Association
Valencia, Valencia
Universidad San Jorge
Zaragoza, Zaragoza, 50830
About this study
Official title: Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial
This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable CF patients.
Read the detailed description
It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms of treatment in a crossover randomization. Each arm of treatment will be apply only in one session. The wash-out period will be one week. Before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess.
During the study period the patients' pharmacological treatment remained unchanged
- Conditions
- Cystic Fibrosis
- Being tested
- Autogenic drainage (AD), Resistive inspiratory manoeuvre (RIM), Resistive inspiratory manoeuvre+autogenic drainage
- Keywords
- Autogenic drainage, Resistive inspiratory manoeuvre, Computerized respiratory sounds, Airway clearance techniques, Mucus clearances
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic drainage (AD)Other
It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
Resistive inspiratory manoeuvre (RIM)Other
It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
Resistive inspiratory manoeuvre+autogenic drainageOther
It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
| Study group | Role | What they receive |
|---|---|---|
| Autogenic drainage (AD) | Active comparator | Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations. Receives: Other: Autogenic drainage (AD) |
| Resistive inspiratory manoeuvre (RIM) | Active comparator | Patients will perform the repetitive inspiratory manoeuvers by breathing through a fixed resistance (Power Breathe device, model KH1) . Each session will comprise to cycles of 5 inspiratory breaths (60% of maximal inspiratory pressure). Patients will be stay in both lateral decubitus position (15 min per side). Receives: Other: Resistive inspiratory manoeuvre (RIM) |
| Resistive inspiratory manoeuvre+autogenic drainage | Active comparator | First, patients will perform the resistive inspiratory manoeuvre during 10 minutes (5 min per side). Right after, patients will perform the autogenic drainage during 20 minutes.The instructions will be similar to described previously. Receives: Other: Resistive inspiratory manoeuvre+autogenic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet sputum production
24h wet sputum production (g) after bronchial drainage session
Measured: 24 hours
Secondary outcomes (4)
Wet sputum production
Wet sputum production (g) during bronchial drainage session
Measured: 30 minutes
Computerized respiratory sounds
Adventitous respiratory sounds: crackles and wheezes
Measured: 30 minutes
Lung function (simply spirometry)
Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Measured: 30 minutes
Patients´ perception
Visual analogical scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2016
- Study completionJun 2016
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.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Beatriz Herrero, Msc, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261987
- Sponsor's protocol ID
- FR_FQ- 013
- Status last verified
- Nov 2016
- First submitted
- 7 Oct 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904.
PubMed 15065835
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02261987
- Acronym / sponsor ID
- FR_FQ- 013
- Conditions
- Cystic Fibrosis
- Keywords
- Autogenic drainage, Resistive inspiratory manoeuvre, Computerized respiratory sounds, Airway clearance techniques, Mucus clearances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Nov 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Oct 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 resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable CF patients.
Detailed description
It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms of treatment in a crossover randomization. Each arm of treatment will be apply only in one session. The wash-out period will be one week. Before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess.
During the study period the patients' pharmacological treatment remained unchanged
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autogenic drainage (AD) | Active comparator | Other: Autogenic drainage (AD)Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations. |
| Resistive inspiratory manoeuvre (RIM) | Active comparator | Other: Resistive inspiratory manoeuvre (RIM)Patients will perform the repetitive inspiratory manoeuvers by breathing through a fixed resistance (Power Breathe device, model KH1) . Each session will comprise to cycles of 5 inspiratory breaths (60% of maximal inspiratory pressure). Patients will be stay in both lateral decubitus position (15 min per side). |
| Resistive inspiratory manoeuvre+autogenic drainage | Active comparator | Other: Resistive inspiratory manoeuvre+autogenic drainageFirst, patients will perform the resistive inspiratory manoeuvre during 10 minutes (5 min per side). Right after, patients will perform the autogenic drainage during 20 minutes.The instructions will be similar to described previously. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l)
- Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk);
- Chronic sputum production, at least ≥ 15 ml /24h
- Familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions)
- To be able to provide written, informed consent
Key exclusion criteria (3 listed)
- Lung function: Forced expiratory volume in 1 second < 30 % pred . ; Forced vital capacity < 40 % pred.
- Active haemoptysis during the previous month
- Supplemental oxygen or non-invasive ventilation (NIV)
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 |
|---|---|---|
| Autogenic drainage (AD)It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order. | Other | Autogenic drainage (AD) |
| Resistive inspiratory manoeuvre (RIM)It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order. | Other | Resistive inspiratory manoeuvre (RIM) |
| Resistive inspiratory manoeuvre+autogenic drainageIt will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order. | Other | Resistive inspiratory manoeuvre+autogenic drainage |
Primary outcome
Wet sputum production
Time frame: 24 hours
24h wet sputum production (g) after bronchial drainage session
4 secondary outcomes
Wet sputum production
Time frame: 30 minutes
Computerized respiratory sounds
Time frame: 30 minutes
Lung function (simply spirometry)
Time frame: 30 minutes
Patients´ perception
Time frame: 30 minutes
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 15 Nov 2016.
- Results publication: PubMed 15065835Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904.
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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.
Beatriz Herrero, Msc principal investigator
Universidad San Jorge
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenic drainage (AD), Resistive inspiratory manoeuvre (RIM) and Resistive inspiratory manoeuvre+autogenic drainage in people with Cystic Fibrosis, run by Universidad San Jorge at 4 sites 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 5 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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: 24 hours). 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 NCT02261987, 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 15 Nov 2016.