Status:
WITHDRAWN
Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy
Lead Sponsor:
University of Kentucky
Conditions:
Asthma
Tobacco Use
Eligibility:
FEMALE
18-35 years
Brief Summary
Asthma and smoking during pregnancy cause significant morbidity in both the mother and the offspring. Asthma represents the most common respiratory disorder during pregnancy and smoking rates during p...
Eligibility Criteria
Inclusion
- Patients need to be pregnant to participate in the study.
- Patients need to be aged 18 to 35 to participate in the study.
- Smokers must have smoked over 100 cigarettes in their lifetime and currently smoke 5 or more cigarettes per day.
- Asthmatics must be diagnosed with asthma and have a current prescription for an asthma medication such as albuterol or an inhaled steroid.
Exclusion
- Nonsmokers
- Cannot have smoked more than 100 cigarettes in their lifetime or currently smoke.
- Cannot have any other lung diseases such as asthma, emphysema (COPD), lung cancer, liver disease, cystic fibrosis or other significant respiratory diseases.
- Cannot have been treated with oral steroids or had a respiratory infection in the 4 weeks before study entry.
- Cannot have another illness that can significantly affect quality of life (such as depression or cancer).
- Smokers
- Cannot have any other lung diseases such as emphysema (COPD), lung cancer, liver disease, cystic fibrosis or other significant respiratory diseases.
- Cannot have been treated with oral steroids or had a respiratory infection in the 4 weeks before study entry.
- Cannot have another illness that can significantly affect quality of life (such as depression or cancer).
- Asthmatics
- Patients in the asthma group cannot have taken theophylline (Theo-24, Theolair, Uniphyl) within 6 months of this study.
- Asthmatics cannot have smoked over 100 cigarettes in their lifetime or be current smokers.
- Cannot have any other lung diseases such as emphysema (COPD), lung cancer, liver disease, cystic fibrosis or other significant respiratory diseases.
- Cannot have been treated with oral steroids or had a respiratory infection in the 4 weeks before study entry.
- Cannot have another illness that can significantly affect quality of life (such as depression or cancer).
- All Subjects
- All subjects will be required to avoid antihistamines for 5 days prior to skin testing (can cause false negative results).
- All subjects will be required to avoid food, drink, exercise, and smoking 1 hour prior to exhaled nitric oxide measurement (could falsely increase or decrease levels), and will need to avoid foods that have a high nitrate content for 24 hours prior to exhaled nitric oxide measurement.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00425880
Start Date
January 1 2007
End Date
October 1 2010
Last Update
August 9 2013
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536