Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00425880
First received: January 22, 2007
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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 pregnancy range from 15-30% in the United States. Maternal asthma and smoking during pregnancy have been shown to increase the rate of intrauterine growth retardation and preterm delivery, as well as increase the risk of wheeze, asthma, respiratory infections, and otitis media in children. However, controlled asthmatics during pregnancy have similar pregnancy outcomes to non-asthmatic pregnancies. Measurement of the fractional concentration of exhaled nitric oxide (FENO) is a new, easily performed, non-invasive method that has been used to assess airway inflammation in adults and children. The long term goal of this study is to establish baseline FENO values and to monitor airway disease in pregnant asthmatics, pregnant smokers and pregnant controls, and to correlate these levels with other inflammatory markers in the mothers and their offspring. These values will be correlated with current methods to diagnose and monitor disease control in these patients. The use of FENO levels in the pregnant asthmatic may prove to be a better method for monitoring disease control and titrating steroid doses in this population. Finally, this study may identify children at higher risk of developing asthma or allergic disease. This could serve to identify factors that may be modified to prevent or limit the development of these diseases in this population.


Condition Phase
Asthma
Tobacco Use
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GCRC: Monitoring and Outcome Measures in Asthmatics and Smokers (MOMAS) During Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Exhaled nitric oxide levels [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inhaled corticosteroid dose [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Asthma control/exacerbations [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Peripheral blood inflammatory markers [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant Asthmatics
Pregnant Smokers
Healthy Pregnant Controls

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from clinics at the University of Kentucky and from the surrounding community.

Criteria

Inclusion Criteria:

  • 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 Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425880

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: James Temprano, M.D., M.H.A. University of Kentucky
  More Information

No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00425880     History of Changes
Other Study ID Numbers: 06-0578-F2L, 2 K12 DA 14040-06
Study First Received: January 22, 2007
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Pregnancy
Asthma
Tobacco Abuse
Exhaled Nitric Oxide

Additional relevant MeSH terms:
Asthma
Tobacco Use Disorder
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014