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Effect of Inhaled Steroids on Gene Expression in the Lungs - 2

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ClinicalTrials.gov Identifier: NCT00826748
Recruitment Status : Terminated (Funding)
First Posted : January 22, 2009
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Drug: Beclomethasone

  Participant Flow

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
24 subjects underwent informed consent and enrolled into the study. 2 smoker subjects screen-failed (recent illicit drug use history of myocardial infarction). These individuals were dropped from the study prior to randomization, therefore only 22 individuals were assigned into one of the three study groups.

Reporting Groups
  Description
Treated Smokers The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
Non-Treated Smokers Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
Non-Smokers Non-Smokers will act as control and include healthy non-smokers who receive no treatment.

Participant Flow:   Overall Study
    Treated Smokers   Non-Treated Smokers   Non-Smokers
STARTED   6   4   12 
COMPLETED   6   4   8 
NOT COMPLETED   0   0   4 
Withdrawal by Subject                0                0                2 
Physician Decision                0                0                1 
Samples Did Not pass QC                0                0                1 



  Baseline Characteristics

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.
The subjects included in this group underwent the screening visit and were determined eligible to undergo the baseline assessments and sample collection procedure.

Reporting Groups
  Description
Treated Smokers The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
Non-Treated Smokers Non-Treated Smokers will act as a control and includes healthy smokers who received no treatment.
Non-smokers Non-Smokers will act as a control and includes healthy non-smokers who received no treatment.
Total Total of all reporting groups

Baseline Measures
   Treated Smokers   Non-Treated Smokers   Non-smokers   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   4   12   22 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6 100.0%      4 100.0%      12 100.0%      22 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      1  25.0%      7  58.3%      8  36.4% 
Male      6 100.0%      3  75.0%      5  41.7%      14  63.6% 


  Outcome Measures

1.  Primary:   Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14   [ Time Frame: Analysis will be done on samples collected on Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on the day prior to initiation of treatment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
The study could not completed as designed due to a lack of funding.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Grace Mammen
Organization: Weill Cornell Medicine
phone: 646-962-2672
e-mail: gwm2004@med.cornell.edu



Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00826748     History of Changes
Other Study ID Numbers: 0809009975
First Submitted: January 21, 2009
First Posted: January 22, 2009
Results First Submitted: March 16, 2017
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018