Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000561482
Ethics application status
Approved
Date submitted
29/10/2007
Date registered
1/11/2007
Date last updated
23/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing Asthma in Pregnancy (MAP) Study
Scientific title
A double-blind randomised controlled trial of FENO guided asthma therapy and clinical guideline guided asthma therapy in pregnant women with asthma to reduce asthma exacerbations
Secondary ID [1] 288606 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The MAP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma control during pregnancy 2512 0
Condition category
Condition code
Respiratory 2608 2608 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Asthma therapy (inhaled corticosteroid and long-acting beta-agonist therapy) adjusted according to exhaled nitric oxide measurement (FENO) during the 2nd and 3rd trimester of pregnancy (approximately 6 months)
Intervention code [1] 2239 0
Other interventions
Comparator / control treatment
Asthma therapy (inhaled corticosteroid and long-acting beta-agonist therapy) adjusted according to clinical guidelines (GINA) during the 2nd and 3rd trimester of pregnancy (approximately 6 months)
Control group
Active

Outcomes
Primary outcome [1] 3520 0
Asthma exacerbations
Timepoint [1] 3520 0
Total number of exacerbations at end of pregnancy. Measured by monthly visits, fortnightly phonecalls and extra home or hospital visits in between these times if an exacerbation occurs
Secondary outcome [1] 5872 0
Short-acting beta-agonist use, inhaled corticosteroid (ICS) dose, quality of life, psychological varaiables, FENO, adherence to medication, birthweight, gestational age
Timepoint [1] 5872 0
Short-acting beta-agonist use & ICS dose recorded monthly, quality of life and psycohological variables recorded at baseline, 1 month, 2months and 4 months

Eligibility
Key inclusion criteria
12-20 weeks gestation
Doctor diagnosis of asthma
Symptoms of asthma or taken treatment for asthma in the last 12 months
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Concomittent chronic medical illness,
chronic lung disease other than asthma, drug or alcohol dependence,
inability to attend study visits,
inability to perform spirometry,
>3 courses of oral corticoseroids (OCS) in past year,
Hospital admission for an asthma exacerbation in the past 3 months,
on regular oral prednisolone or theophylline

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by blinded list held by independent statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random number list stratified by ICS dose (<800 mcgday or >=800mcg/day) and smoking status (non/exsmokers and current smokers)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
28/05/2007
Date of last participant enrolment
Anticipated
Actual
9/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
242
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5325 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 5326 0
The Maitland Hospital - Maitland
Recruitment postcode(s) [1] 308 0
2305
Recruitment postcode(s) [2] 309 0
2320

Funding & Sponsors
Funding source category [1] 2755 0
Government body
Name [1] 2755 0
National Health and Medical Research Council of Australia
Country [1] 2755 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Health
Address
Locked BAG # 1
HRMC
NSW 2310
Country
Australia
Secondary sponsor category [1] 2489 0
Individual
Name [1] 2489 0
Prof Peter Gibson
Address [1] 2489 0
Department of Respiratory & Sleep Medicine
HMRI, John Hunter Hospital
Locked bag#1
HRMC
NSW 2310
Country [1] 2489 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4676 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 4676 0
Locked Bag#1
New Lambton
NSW 2305
Ethics committee country [1] 4676 0
Australia
Date submitted for ethics approval [1] 4676 0
Approval date [1] 4676 0
01/03/2007
Ethics approval number [1] 4676 0
07/02/21/3.06

Summary
Brief summary
This study in pregnant women with asthma compares the guiding of asthma therapy by FENO level to asthma therapy guided by clinical guidelines on reducing asthma exacerbations during pregnancy
Trial website
Trial related presentations / publications
Papers
1: Powell H, Murphy VE, Taylor DR, Hensley MJ, McCaffery K, Giles W, Clifton VL,
Gibson PG. Management of asthma in pregnancy guided by measurement of fraction of
exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet. 2011
Sep 10;378(9795):983-90. doi: 10.1016/S0140-6736(11)60971-9. PubMed PMID:
21907861.

2: Powell H, McCaffery K, Murphy VE, Hensley MJ, Clifton VL, Giles W, Gibson PG.
Psychosocial outcomes are related to asthma control and quality of life in
pregnant women with asthma. J Asthma. 2011 Dec;48(10):1032-40. doi:
10.3109/02770903.2011.631239. PubMed PMID: 22091740.

3: Powell H, McCaffery K, Murphy VE, Hensley MJ, Clifton VL, Giles W, Gibson PG.
Psychosocial variables are related to future exacerbation risk and perinatal
outcomes in pregnant women with asthma. J Asthma. 2013 May;50(4):383-9. doi:
10.3109/02770903.2012.757777. Epub 2013 Jan 31. PubMed PMID: 23368420.

4: Burgess L, McCaffery K, Powell H, Murphy VE, Gibson PG, Turner RM. The
influence of asthma control on psychosocial outcomes for pregnant women with
asthma. J Asthma. 2015 Dec;52(10):1013-9. doi: 10.3109/02770903.2015.1038833.
Epub 2015 Aug 24. PubMed PMID: 26313124.

5: Powell H, Murphy VE, Hensley MJ, Giles W, Clifton VL, Gibson PG. Rhinitis in
pregnant women with asthma is associated with poorer asthma control and quality
of life. J Asthma. 2015 Dec;52(10):1023-30. doi: 10.3109/02770903.2015.1054403.
Epub 2015 Sep 12. PubMed PMID: 26365758.

Abstracts

1. Powell H, McCaffery K, Murphy VE, Giles W, Clifton VL, Hensley MJ, McCaffery K, Gibson PG. Psychosocial outcomes are related to future exacerbation risk and perinatal outcomes in pregnant women with asthma. Respirology 2012; 17(Suppl 1):49.
2. Powell H, Giles W, Clifton VL, Hensley MJ, Taylor DR, Murphy VE, McCaffery K, Gibson PG. Asthma exacerbations during pregnancy are reduced by inflammometry (FENO) guided asthma management: a randomised controlled trial. Am J Respir Crit Care Med 2011 3. Steel K, McLaughlin, K, McCaffery K, Powell H, Clifton VL, Giles, W, Hensley MJ, Gibson, PG. Psychosocial characteristics and perceived medication risk in pregnant women with asthma. Respirology 2010;15(Suppl 1):A44
4. H Powell, V Murphy, PG Gibson. The relationship between FENO and atopic status in pregnant women with asthma. Respirology 2009;14(Suppl. 1):A37.
5. McLaughlin K, Murphy V, McCaffery K, Powell H, Clifton VL, Giles W, Hensley MJ, Gibson P. The relationship between patient perceived risk of inhaled corticosteroids in pregnancy and medication adherence. Respirology 2009;14(Suppl. 1):A42.
Public notes

Contacts
Principal investigator
Name 28151 0
Prof Peter Gibson
Address 28151 0
Locked bag#1
HRMC
NSW 2310
Country 28151 0
Australia
Phone 28151 0
0240420142
Fax 28151 0
Email 28151 0
peter.gibson@hnehealth,.nsw.gov.au
Contact person for public queries
Name 11308 0
Prof Prof Peter Gibson
Address 11308 0
Department of Respiratory & Sleep Medicine
HMRI, John Hunter Hospital
Locked bag#1
HRMC
NSW 2310
Country 11308 0
Australia
Phone 11308 0
0240420142
Fax 11308 0
02 498 55850
Email 11308 0
[email protected]
Contact person for scientific queries
Name 2236 0
Prof Prof Peter Gibson
Address 2236 0
Department of Respiratory & Sleep Medicine
HMRI, John Hunter Hospital
Locked bag#1
HRMC
NSW 2310
Country 2236 0
Australia
Phone 2236 0
0240420142
Fax 2236 0
0240420046
Email 2236 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRhinitis in pregnant women with asthma is associated with poorer asthma control and quality of life.2015https://dx.doi.org/10.3109/02770903.2015.1054403
EmbaseRhinovirus bronchiolitis, maternal asthma, and the development of asthma and lung function impairments.2021https://dx.doi.org/10.1002/ppul.25165
EmbaseHow Maternal BMI Modifies the Impact of Personalized Asthma Management in Pregnancy.2020https://dx.doi.org/10.1016/j.jaip.2019.06.033
N.B. These documents automatically identified may not have been verified by the study sponsor.