Cystic FibrosisNCT01737801
Time to Perform Lung Function Test in Cystic Fibrosis
A study testing Lung function test in people with Cystic Fibrosis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Time to perform lung function test after chest physiotherapy in cystic fibrosis. The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital capacity). Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Lung function test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2008to Sep 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with cystic fibrosis
Who cannot join
- patients with cystic fibrosis who could not stay at the clinic for more than 4 hrs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time to Perform Lung Function Test in Cystic Fibrosis After Chest Physiotherapy.
Time to perform lung function test after chest physiotherapy in cystic fibrosis.
The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital capacity).
Read the detailed description
The patients perform spirometry before, direct after, 30 minutes, 1 hour, 2 hours, and 3 hours after physiotherapist. The investigators want to study the FEV1 and FVC.
- Conditions
- Cystic Fibrosis
- Being tested
- Lung function test
- Keywords
- Lung function, 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.
Lung function testProcedure or surgery
Also called Lung function test.
Lung function test.
| Study group | Role | What they receive |
|---|---|---|
| Lung function test | Experimental | Lung function test Receives: Procedure: Lung function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function test. FEV1 and FVC
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startFeb 2008
- Primary completionJan 2012
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Rodriguez, Karolinska University Hospital
- Investigators
- Cecilia Rodriguez, Physio, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737801
- Sponsor's protocol ID
- 2012-CF-2
- Status last verified
- Nov 2012
- First submitted
- 19 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Perform Lung Function Test in Cystic Fibrosis After Chest Physiotherapy.
- ClinicalTrials.gov ID
- NCT01737801
- Acronym / sponsor ID
- 2012-CF-2
- Conditions
- Cystic Fibrosis
- Keywords
- Lung function, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Nov 2012 (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.
Time to perform lung function test after chest physiotherapy in cystic fibrosis.
The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital capacity).
Detailed description
The patients perform spirometry before, direct after, 30 minutes, 1 hour, 2 hours, and 3 hours after physiotherapist. The investigators want to study the FEV1 and FVC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung function test | Experimental | Procedure: Lung function testLung function test |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cystic fibrosis
Key exclusion criteria (1 listed)
- patients with cystic fibrosis who could not stay at the clinic for more than 4 hrs.
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 |
|---|---|---|
| Lung function testAlso: Lung function test.Lung function test. | Procedure or surgery | Lung function test |
Primary outcome
Lung function test. FEV1 and FVC
Time frame: 2 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 30 Nov 2012.
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Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
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Cystic Fibrosis (CF)
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.
Cecilia Rodriguez, Physio principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung function test in people with Cystic Fibrosis, run by Karolinska University Hospital at 1 site in Sweden.
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 30 Nov 2012. 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 Sweden. 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?
Lung function test. FEV1 and FVC (time frame: 2 days). 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 Nov 2012.