National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

MFMU Network Randomized Clinical Trial of
Theophylline versus Inhaled Beclomethasone

Related Publications & Presentations

Objective

To determine if prolonged anti-inflammatory therapy with inhaled corticosteroids will result in better control of moderate asthma in pregnancy.

Conclusion

Despite its greater anti-inflammatory effects, beclomethasone treatment of moderate persistent asthma resulted in similar rates of asthma exacerbations requiring medical intervention, and pregnancy outcomes vs. treatment with theophyline.

Clinical Centers

Magee Womens, Tennessee, Southern California, Alabama, Wayne State, Cincinnati, Oklahoma, Bowman Gray, Chicago. Ohio State, MUSC, UT San Antonio, UTDallas, Utah, Miami, Thomas Jefferson

Major Eligibility Criteria

• Gestational age < 26 weeks
• Singleton
• No pulmonary, cardiac endocrine, hematologic, liver disease
• Informed consent

Sample Size

• Goal = 400 (200/group)

Groups

• Active theophylline (400-800 mg/day); placebo inhaled
• Active beclomethasone (504 mcg/day); placebo oral medication

Management Protocols

• Coded medication:
• Initial dose: 2 capsules twice daily (400 mg/day) & 4 puffs threetimes daily (504 mcg/day)
• At day 3: Increase to 600 mg/day
• Dose changes:
• After theophylline level. BCC instructs to increase/decrease dose to maintain 8-12 mcg/ml serum level
• After day 3: Dose: 400, 600, 800
• Coded meds discontinued:
• Severe side effects; treatment failure(hospitalization > 48 hours or 3exacerbations)

Outcome Measures

• Primary:
• Occurrence of an asthma excerbation requiring emergency visit/hospitalization/oral steroid
• Secondary:
• Mean PEFR, FEV1
• Low birth weight (< 2500 gm)
• Perinatal morbidity and mortality
• Preterm delivery rate < 37 weeks
• Maternal asthma morbidity
• Pregnancy complications

Timetable

• Randomization: 10/95-06/99
• Data Collection: 10/95-02/00
• Closeout/Final Analysis: 02/00-10/00