ANZCTR - Registration

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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]

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

Condition category

Condition code

Respiratory

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]

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]

Asthma exacerbations

Timepoint [1]

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]

Short-acting beta-agonist use, inhaled corticosteroid (ICS) dose, quality of life, psychological varaiables, FENO, adherence to medication, birthweight, gestational age

Timepoint [1]

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?

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]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment hospital [2]

The Maitland Hospital - Maitland

Recruitment postcode(s) [1]

2305

Recruitment postcode(s) [2]

2320

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council of Australia

Address [1]

GPO Box 1421,
Canberrra
ACT

Country [1]

Australia

Primary sponsor type

Hospital

Name

Hunter New England Health

Address

Locked BAG # 1
HRMC
NSW 2310

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Prof Peter Gibson

Address [1]

Department of Respiratory & Sleep Medicine
HMRI, John Hunter Hospital
Locked bag#1
HRMC
NSW 2310

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag#1
New Lambton
NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/03/2007

Ethics approval number [1]

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

Prof Peter Gibson

Address

Locked bag#1
HRMC
NSW 2310

Country

Australia

Phone

0240420142

Fax

peter.gibson@hnehealth,.nsw.gov.au

Contact person for public queries

Name

Prof Peter Gibson

Address

Department of Respiratory & Sleep Medicine
HMRI, John Hunter Hospital
Locked bag#1
HRMC
NSW 2310

Country

Australia

Phone

0240420142

Fax

02 498 55850

Peter.Gibson@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Prof Peter Gibson

Address

Department of Respiratory & Sleep Medicine
HMRI, John Hunter Hospital
Locked bag#1
HRMC
NSW 2310

Country

Australia

Phone

0240420142

Fax

0240420046

Peter.Gibson@hnehealth.nsw.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Rhinitis in pregnant women with asthma is associated with poorer asthma control and quality of life.	2015	https://dx.doi.org/10.3109/02770903.2015.1054403
Embase	How Maternal BMI Modifies the Impact of Personalized Asthma Management in Pregnancy.	2020	https://dx.doi.org/10.1016/j.jaip.2019.06.033
Embase	Rhinovirus bronchiolitis, maternal asthma, and the development of asthma and lung function impairments.	2021	https://dx.doi.org/10.1002/ppul.25165

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically