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

NCT03076086 | Completed

• 1 other identifier: 16-11 SPUFO I
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Smoking, Cigarette

Outcome Measures

Primary Outcomes (1)

• Biomarker assessment

  concentration of PiP3 and phosphoproteins in sputum samples

  up to 3 weeks

Study Arms (1)

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.

Other: Induced sputum procedure

Interventions

Induced sputum procedure OTHER

induced sputum is a sputum specimen produced for diagnostic tests by aerosol administration of a hypertonic saline solution.

induced sputum procedure

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer ITEM

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Jens Hohlfeld, MD

  Fraunhofer-Institute of Toxicology and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: May 12, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: February 1, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)