HealthyNCT03076086
Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum
A study testing Induced sputum procedure in people with Healthy and Smoking, Cigarette, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The aim of this study is to validate two new biomarkers in sputum samples. These are PiP3 (phosphoinositolphospat ) and phosphor proteins, representing important proteins within inflammatory situations of the lung. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Smoking, Cigarette
- What is being tested?
- Induced sputum procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2017to 15 Jan 2018
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Healthy male and female subjects, aged 25-45 years. Women will be considered for inclusion if they are not pregnant, as confirmed by pregnancy test and not nursing.
- Females of childbearing potential need to use a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first visit until at least 72 hours after the last visit -, implants, injectables, combined oral contraceptives, hormonal IUDs (intrauterine device) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Body weight ≥ 50 kg and BMI (body mass index) within the range 19-32 kg/m²
- Smokers need to consume at least ten cigarettes per day and need to have at least ten packyear
- Non-smokers need to be non-smoking since at least a year with a smoking history of no more than 1 packyear.
- FEV1 (forced expiratory volume at one second)≥80% predicted and FEV1/FVC (forced expiratory vital capacity) ≥70%
Who cannot join
- • History of an acute infection four weeks prior to the informed consent visit.
- Regular intake of medication.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Participation in another clinical trial 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum Samples of Healthy Smokers and Non Smokers
The aim of this study is to validate two new biomarkers in sputum samples. These are PiP3 (phosphoinositolphospat ) and phosphor proteins, representing important proteins within inflammatory situations of the lung.
Read the detailed description
Within the study, sputum samples will be collected at 3 repetitive occasions in a 3 week interval of the different donors.
The objective is to assess for biomarker specificity and reproducibility in the two groups (smokers and non-smokers). The methods for measurement shall be validated by repetitive measurement of the sputum samples, i.e. comparison of multiple measurements of the same sample and comparison of different samples from the same donor.
- Conditions
- Healthy, Smoking, Cigarette
- Being tested
- Induced sputum procedure
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced sputum procedureOther
induced sputum is a sputum specimen produced for diagnostic tests by aerosol administration of a hypertonic saline solution.
| Study group | Role | What they receive |
|---|---|---|
| induced sputum procedure | Experimental | Biomarker assessment (concentration of PiP3 and phosphoproteins in sputum samples) baseline and reproducibility twice in a 3 week interval of the different donors. Receives: Other: Induced sputum procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker assessment
concentration of PiP3 and phosphoproteins in sputum samples
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start12 May 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, MD, Principal investigator, Fraunhofer-Institute of Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076086
- Sponsor's protocol ID
- 16-11 SPUFO I
- Status last verified
- May 2017
- First submitted
- 6 Mar 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum Samples of Healthy Smokers and Non Smokers
- ClinicalTrials.gov ID
- NCT03076086
- Acronym / sponsor ID
- 16-11 SPUFO I
- Conditions
- Healthy, Smoking, Cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- 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.
The aim of this study is to validate two new biomarkers in sputum samples. These are PiP3 (phosphoinositolphospat ) and phosphor proteins, representing important proteins within inflammatory situations of the lung.
Detailed description
Within the study, sputum samples will be collected at 3 repetitive occasions in a 3 week interval of the different donors.
The objective is to assess for biomarker specificity and reproducibility in the two groups (smokers and non-smokers). The methods for measurement shall be validated by repetitive measurement of the sputum samples, i.e. comparison of multiple measurements of the same sample and comparison of different samples from the same donor.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| induced sputum procedure | Experimental | Other: Induced sputum procedureBiomarker assessment (concentration of PiP3 and phosphoproteins in sputum samples) baseline and reproducibility twice in a 3 week interval of the different donors. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Healthy male and female subjects, aged 25-45 years. Women will be considered for inclusion if they are not pregnant, as confirmed by pregnancy test and not nursing.
- Females of childbearing potential need to use a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first visit until at least 72 hours after the last visit -, implants, injectables, combined oral contraceptives, hormonal IUDs (intrauterine device) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Body weight ≥ 50 kg and BMI (body mass index) within the range 19-32 kg/m²
- Smokers need to consume at least ten cigarettes per day and need to have at least ten packyear
- Non-smokers need to be non-smoking since at least a year with a smoking history of no more than 1 packyear.
Key exclusion criteria (4 listed)
- • History of an acute infection four weeks prior to the informed consent visit.
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 |
|---|---|---|
| Induced sputum procedureinduced sputum is a sputum specimen produced for diagnostic tests by aerosol administration of a hypertonic saline solution. | Other | induced sputum procedure |
Primary outcome
Biomarker assessment
Time frame: up to 3 weeks
concentration of PiP3 and phosphoproteins in sputum samples
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 1 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Jens Hohlfeld, MD principal investigator
Fraunhofer-Institute of Toxicology and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced sputum procedure in people with Healthy and Smoking, Cigarette, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
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 6 inclusion and 4 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 1 Feb 2018. 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 Germany. 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?
Biomarker assessment (time frame: up to 3 weeks). 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 1 Feb 2018.