Cystic FibrosisPhase 4NCT01377792
Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis
A Phase 4 study testing Hypertonic saline in people with Cystic Fibrosis, run by Adelaida Lamas Ferreiro at 1 site in Spain.
Trial summary
A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Hypertonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Sep 2012
- Phase
- Phase 4
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Cystic fibrosis
- Over 6 years old
- FEV1 over than 30%
- Must be able to perform a spirometry
- Must be able to perform induced sputum
- Must tolerate the maximum dose of 10 ml hypertonic saline
- No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study
- No treatment with hypertonic saline in the 2 weeks before
Who cannot join
- No clinical diagnosis of Cystic Fibrosis
- No tolerance of 10 ml of hypertonic saline
- Positive pregnancy test
- No tolerance of Beta2-agonist
- Treatment with corticosteroids
- FEV1 < 30%
Show all 12Show fewer
- Liver and/or lung transplantation
- Oxygen treatment
- Hospital admission within the 4 previous weeks
- Oral or intravenous antibiotic treatment within the 2 previous weeks
- Smokers
- Pulmonary colonisation with Burkholderia cepacia complex
Trial locations and contacts
1 site in 1 country.
Spain1 site
Cystic Fibrosis Unit. Ramón y Cajal University Hospital
Madrid, Madrid, 28034
About this study
Official title: Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis
A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.
- Conditions
- Cystic Fibrosis
- Being tested
- Hypertonic saline
- Keywords
- hypertonic saline, cystic fibrosis, pulmonary inflammation, pulmonary exacerbation
- Medical subject headings
- Cystic Fibrosis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDrug
comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| 5 ml | Active comparator | Not described Receives: Drug: Hypertonic saline |
| 10 ml | Active comparator | Not described Receives: Drug: Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free time, specified in days, of pulmonary exacerbation
Exact number of days, along 48 weeks of tretment with hypertonic saline, in wich the patient is free of pulmonary excaerbation symptoms and does not need antibiotics.
Measured: 12 months
Secondary outcomes (3)
Changes in lung function test measured by spirometry
Measured: 12 months
Changes in inflammatory markers during the treatment
Measurement of inflammatory markers in induced sputum.
Measured: 12 months
Quality of life
Measurement of quality of life of patients during treatment by CFQ-R test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionSep 2012
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adelaida Lamas Ferreiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adelaida Lamas Ferreiro, Hospital Universitario Ramon y Cajal
- Investigators
- Adelaida Lamas, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377792
- Sponsor's protocol ID
- SSH-FQ1
- Status last verified
- Jan 2013
- First submitted
- 9 May 2011
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01377792
- Acronym / sponsor ID
- SSH-FQ1
- Conditions
- Cystic Fibrosis
- Keywords
- hypertonic saline, cystic fibrosis, pulmonary inflammation, pulmonary exacerbation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Adelaida Lamas FerreiroUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Jun 2011 (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.
A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 ml | Active comparator | Drug: Hypertonic saline |
| 10 ml | Active comparator | Drug: Hypertonic saline |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of Cystic fibrosis
- Over 6 years old
- FEV1 over than 30%
- Must be able to perform a spirometry
- Must be able to perform induced sputum
Key exclusion criteria (12 listed)
- No clinical diagnosis of Cystic Fibrosis
- No tolerance of 10 ml of hypertonic saline
- Positive pregnancy test
- No tolerance of Beta2-agonist
- Treatment with corticosteroids
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 salinecomparison of different dosages of drug | Drug | 10 ml, 5 ml |
Primary outcome
Free time, specified in days, of pulmonary exacerbation
Time frame: 12 months
Exact number of days, along 48 weeks of tretment with hypertonic saline, in wich the patient is free of pulmonary excaerbation symptoms and does not need antibiotics.
3 secondary outcomes
Changes in lung function test measured by spirometry
Time frame: 12 months
Changes in inflammatory markers during the treatment
Time frame: 12 months
Quality of life
Time frame: 12 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 30 Jan 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.
Adelaida Lamas, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypertonic saline in people with Cystic Fibrosis, run by Adelaida Lamas Ferreiro 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 8 inclusion and 12 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 30 Jan 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Free time, specified in days, of pulmonary exacerbation (time frame: 12 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 30 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.