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Nasal Epithelial Cells/Blood Lymphocyte Markers for Cystic Fibrosis (CF)/CF Pulmonary Exacerbations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00381628
First Posted: September 28, 2006
Last Update Posted: February 15, 2017
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.
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
James F. Chmiel, University Hospitals Cleveland Medical Center
Results First Submitted: December 7, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Control;   Time Perspective: Prospective
Condition: Cystic Fibrosis
Intervention: Procedure: epithelial cells and blood lymphocyte extraction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stable Subjects With CF

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Exacerbating Subjects With CF

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Stable Subjects With Asthma

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Healthy Volunteers

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.


Participant Flow:   Overall Study
    Stable Subjects With CF   Exacerbating Subjects With CF   Stable Subjects With Asthma   Healthy Volunteers
STARTED   18   27   0   14 
COMPLETED   18   27   0   14 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stable Subjects With CF

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Exacerbating Subjects With CF

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Stable Subjects With Asthma

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Healthy Volunteers

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group

epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Total Total of all reporting groups

Baseline Measures
   Stable Subjects With CF   Exacerbating Subjects With CF   Stable Subjects With Asthma   Healthy Volunteers   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   27   0   14   59 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      2  11.1%      2   7.4%         0   0.0%      4   6.8% 
Between 18 and 65 years      15  83.3%      25  92.6%         14 100.0%      54  91.5% 
>=65 years      1   5.6%      0   0.0%         0   0.0%      1   1.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      4  22.2%      10  37.0%         9  64.3%      23  39.0% 
Male      14  77.8%      17  63.0%         5  35.7%      36  61.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   18   27   0   14   59 


  Outcome Measures

1.  Primary:   The Number of Participants With Blood and Sputum Samples Collected   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. James Chmiel
Organization: University Hospitals Cleveland Medical Center
phone: 216-844-3267
e-mail: James.Chmiel@uhhospitals.org



Responsible Party: James F. Chmiel, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00381628     History of Changes
Other Study ID Numbers: Protocol 08-06-23
First Submitted: September 27, 2006
First Posted: September 28, 2006
Results First Submitted: December 7, 2016
Results First Posted: February 15, 2017
Last Update Posted: February 15, 2017