Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy
7. august 2013 oppdatert av: University of Kentucky
GCRC: Monitoring and Outcome Measures in Asthmatics and Smokers (MOMAS) During Pregnancy
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.
Studieoversikt
Status
Tilbaketrukket
Forhold
Studietype
Observasjonsmessig
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- University of Kentucky
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 35 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Subjects will be recruited from clinics at the University of Kentucky and from the surrounding community.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Pregnant Asthmatics
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Pregnant Smokers
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Healthy Pregnant Controls
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Exhaled nitric oxide levels
Tidsramme: 9 months
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9 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Inhaled corticosteroid dose
Tidsramme: 9 months
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9 months
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Asthma control/exacerbations
Tidsramme: 9 months
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9 months
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Peripheral blood inflammatory markers
Tidsramme: 9 months
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9 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: James Temprano, M.D., M.H.A., University of Kentucky
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2007
Primær fullføring (Faktiske)
1. oktober 2010
Studiet fullført (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først innsendt
22. januar 2007
Først innsendt som oppfylte QC-kriteriene
22. januar 2007
Først lagt ut (Anslag)
23. januar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. august 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. august 2013
Sist bekreftet
1. august 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 06-0578-F2L
- 2K12DA014040-06 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .