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Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076086
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Fraunhofer-Institute of Toxicology and Experimental Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Smoking, Cigarette Other: Induced sputum procedure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum Samples of Healthy Smokers and Non Smokers
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 15, 2018

Arm Intervention/treatment
Experimental: induced sputum procedure
Biomarker assessment (concentration of PiP3 and phosphoproteins in sputum samples) baseline and reproducibility twice in a 3 week interval of the different donors.
Other: Induced sputum procedure
induced sputum is a sputum specimen produced for diagnostic tests by aerosol administration of a hypertonic saline solution.




Primary Outcome Measures :
  1. Biomarker assessment [ Time Frame: up to 3 weeks ]
    concentration of PiP3 and phosphoproteins in sputum samples



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • 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%

Exclusion Criteria:

  • • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076086


Locations
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Germany
Fraunhofer ITEM
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Investigators
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Principal Investigator: Jens Hohlfeld, MD Fraunhofer-Institute of Toxicology and Experimental Medicine

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Responsible Party: Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03076086     History of Changes
Other Study ID Numbers: 16-11 SPUFO I
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No