NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000578

Purpose

To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.

Condition	Intervention	Phase
Asthma Lung Diseases	Drug: theophylline Drug: beclomethasone	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Beclomethasone dipropionate Beclomethasone Theophylline Theophylline sodium glycinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	April 1994
Estimated Study Completion Date:	October 2000

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Asthmatic pregnant women.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Wright LL, McNellis D. National Institute of Child Health and Human Development (NICHD)-sponsored Perinatal Research Networks. Semin Perinatol. 1995 Apr;19(2):112-23. Review. No abstract available.

Dombrowski MP, Schatz M, Wise R, Momirova V, Landon M, Mabie W, Newman RB, McNellis D, Hauth JC, Lindheimer M, Caritis SN, Leveno KJ, Meis P, Miodovnik M, Wapner RJ, Paul RH, Varner MW, O'Sullivan MJ, Thurnau GR, Conway DL; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and the National Heart, Lung, and Blood Institute. Asthma during pregnancy. Obstet Gynecol. 2004 Jan;103(1):5-12.

Dombrowski MP, Schatz M, Wise R, Thom EA, Landon M, Mabie W, Newman RB, McNellis D, Hauth JC, Lindheimer M, Caritis SN, Leveno KJ, Meis P, Miodovnik M, Wapner RJ, Varner MW, O'Sullivan MJ, Conway DL; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network; National Heart, Lung, and Blood Institute. Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy. Am J Obstet Gynecol. 2004 Mar;190(3):737-44.

Study ID Numbers:	216
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000578
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Beclomethasone
Asthma
Theophylline
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Enzyme Inhibitors

Cardiovascular Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009