Cystic FibrosisNCT01943890
High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients
A study testing Hypertonic saline and Physiotherapy in people with Cystic Fibrosis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Hypertonic saline and Physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2010to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cystic fibrosis
Who cannot join
- Non-adherence
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Thoracic Medicine, Haukeland University Hospital
Bergen, N-5021
About this study
Official title: Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients
Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.
The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.
Read the detailed description
Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy.
HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age > 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.
- Conditions
- Cystic Fibrosis
- Being tested
- Hypertonic saline, Physiotherapy
- Keywords
- Hypertonic saline, Lung physiotherapy
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDevice
1 mmol/ml hypertonic saline given from (small children) 1,5 ml in 3 positions twice daily increasing to (children) 2 ml in 3 positions twice daily and up to (adults) 3 ml in 3 positions twice daily
PhysiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy and hypertonic saline | Experimental | Chest physiotherapy integrated with inhalation of hypertonic saline Receives: Device: Hypertonic saline; Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
Measured: 24 months
Secondary outcomes (1)
Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients
Establishment of a standardized routine of nebulised high volumes of hypertonic saline including chest physiotherapy in cystic fibrosis patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stian Hammer, Principal investigator, Dept. of Physiotherapy, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943890
- Sponsor's protocol ID
- 2009/2125
- Status last verified
- Sep 2013
- First submitted
- 16 May 2012
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT01943890
- Acronym / sponsor ID
- 2009/2125
- Conditions
- Cystic Fibrosis
- Keywords
- Hypertonic saline, Lung physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Sep 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.
Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.
The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.
Detailed description
Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy.
HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age > 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy and hypertonic saline | Experimental | Device: Hypertonic saline, Procedure: PhysiotherapyChest physiotherapy integrated with inhalation of hypertonic saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cystic fibrosis
Key exclusion criteria (1 listed)
- Non-adherence
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 |
|---|---|---|
| Hypertonic saline1 mmol/ml hypertonic saline given from (small children) 1,5 ml in 3 positions twice daily increasing to (children) 2 ml in 3 positions twice daily and up to (adults) 3 ml in 3 positions twice daily | Device | Physiotherapy and hypertonic saline |
| Physiotherapy | Procedure or surgery | Physiotherapy and hypertonic saline |
Primary outcome
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
Time frame: 24 months
1 secondary outcome
Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients
Time frame: 24 months
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 17 Sep 2013.
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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.
Stian Hammer principal investigator
Dept. of Physiotherapy, Haukeland University Hospital, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline and Physiotherapy in people with Cystic Fibrosis, run by Haukeland University Hospital at 1 site in Norway.
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 1 inclusion and 1 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 17 Sep 2013. 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 Norway. 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?
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second (time frame: 24 months). 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 17 Sep 2013.