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The Breathing for Life Trial: A randomised controlled trial of fractional exhaled nitric oxide based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health

The Breathing for Life Trial: A multi-centre randomised controlled trial of fractional exhaled nitric oxide based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000202763
Acronym
BLT
Enrollment
1200
Registered
2013-02-19
Start date
2013-03-07
Completion date
2019-06-11
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study in pregnant women with asthma investigates the maternal, infant and childhood outcomes following asthma treatment adjustment using FENO, compared to standardised usual care treatment adjustment.

Interventions

FENO Algorithm: Fractional exhaled nitric oxide (FENO) is a non-invasive marker of airway inflammation in asthma. FENO will be measured at monthly visits during the second and third trimesters pregnancy and the level used to adjust maintenance asthma therapy. When FENO is high, inhaled corticosteroid therapy will be increased, when FENO is in a mid-range no change will be made to ICS, and when FENO is low, ICS will be decreased. If symptoms are present (assessed using the asthma control questio

FENO Algorithm: Fractional exhaled nitric oxide (FENO) is a non-invasive marker of airway inflammation in asthma. FENO will be measured at monthly visits during the second and third trimesters pregnancy and the level used to adjust maintenance asthma therapy. When FENO is high, inhaled corticosteroid therapy will be increased, when FENO is in a mid-range no change will be made to ICS, and when FENO is low, ICS will be decreased. If symptoms are present (assessed using the asthma control questionnaire), long acting beta agonist (LABA) will be added.

Sponsors

John Hunter Hospital (Hunter New England Local Health District)
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

12-22 weeks gestation

Exclusion criteria

Inability to attend monthly study visits, inability to perform manoeuvres required for spirometry or FENO, drug or alcohol dependence, unknown dates, chronic oral steroid use or use of immunosuppressant therapy.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 13, 2026