Asthma Clinical Trial
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.
BACKGROUND:
Asthma is one of the most common illnesses that complicates pregnancy. Asthma complicates at
least 4 percent of all pregnancies; however, because at least 10 percent of the population
appears to have nonspecific airway hyper-responsiveness, the true prevalence may be much
higher.
Asthma can produce serious maternal and fetal complications. A number of investigators have
reported an increased incidence of pre-eclampsia, gestational hypertension, hyperemesis
gravidarum, vaginal hemorrhage, toxemia, and induced and complicated labor. Fetal
complications include increased risk of perinatal mortality, prematurity, low birth weight,
and neonatal hypoxia. In contrast, several studies have failed to confirm some or all of
these previous observations. Patients with severe asthma may have the greatest risk for
complications during pregnancy, in addition to the risk of maternal morbidity from the
asthma. For example, it has been shown that reduced pulmonary function in asthmatic women is
associated with an increased likelihood of intrauterine growth retardation. On the other
hand, studies in which asthma was successfully controlled have resulted in pregnancy
outcomes similar to the general population.
The mechanisms by which asthma may have adverse perinatal effects are not well known. Poor
control of asthma leading to chronic or episodic fetal hypoxia is thought to be important.
Medications used in asthma treatment may also play a role, although the limited data
suggests minimal or no effects. In addition, it is possible that extrapulmonary autonomic
nervous system abnormalities, such as uterine muscle hyperreactivity, could contribute to
pre-term delivery or gestational hypertension independent of asthma control or therapy.
Unfortunately, previous studies have been limited by relatively small numbers. Few studies
have controlled for factors known to affect infant birth weight, such as maternal race,
height, weight, parity, nutrition, and cigarette smoking. Particularly, race may be an
important contributing factor in assessing the relationship between asthma and pregnancy
outcomes, since Blacks of both sexes are twice as likely to be hospitalized from asthma and
three times as likely to die from asthma as whites.
Under the auspices of the National Asthma Education Program (NAEP), a Working Group on
Asthma and Pregnancy developed a statement regarding the treatment of asthma during
pregnancy. In its deliberations, the Working Group noted the paucity of data on the relative
contributions of biological, social, and environmental factors on asthma in pregnant women,
as well as the lack of data on the efficacy and safety of commonly used asthma therapies in
pregnancy.
DESIGN NARRATIVE:
The Asthma in Pregnancy Study evaluated the relationship between maternal asthma severity
and control. The primary objective was to determine the frequency of preterm delivery <32
weeks among moderate and severe asthmatics compared to non-asthmatic controls. The incidence
of small-for-gestational-age infants in women with mild and moderate asthma was a secondary
outcome. Other independent variables included type of medications used, race, socioeconomic
status, height, weight, parity, nutrition, smoking, other substance abuse, and prenatal
care. Secondary outcomes included birth weight and prematurity, maternal pre-eclampsia,
gestational hypertension, and asthma morbidity. The study began February 1,1995 and patient
recruitment continued for 46 months or less.
The Asthma Therapy in Pregnancy Trial was a randomized, double-blind, controlled clinical
trial which began recruitment in November, 1996, with enrollment lasting 44 months. Patients
were randomized to receive either active oral theophylline and a placebo beclomethasone
inhaler or an active beclomethasone inhaler and placebo oral theophylline. Albuterol was
used for relief of symptoms. The primary outcome measure was incidence of Emergency
Department visits or hospitalizations during pregnancy. Secondary outcome measures included
birth weight, incidence of small-for-gestational-age infants, gestational hypertension,
pre-eclampsia, lung function, daily peak flow, and quality of life. Patients were seen
monthly for measurements of fetal growth, morbidity, and lung function. Extensive interviews
were conducted with each patient at the first prenatal visit, in the third trimester, and
shortly before birth.
The study completion date listed in this record was obtained from the "Completed Date"
entered in the Query View Report System (QVR).
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|