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Assessment of inflammatory characteristics and cell function with changes in asthma control

Assessment of asthma phenotype and airway neutrophil function after changes in asthma control/medication in adult asthmatics

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001356358
Enrollment
45
Registered
2017-09-27
Start date
2010-09-01
Completion date
2011-08-08
Last updated
2017-10-02

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

Conditions

None listed

Brief summary

Asthma inflammatory phenotypes are often defined by relative cell counts of airway eosinophils/neutrophils. However, the importance of neutrophilia remains unclear, as does the effect of ICS treatment on asthma phenotypes and airway neutrophil function. The purpose of this study was to determine how treatment changes affect phenotype stability and inflammation, with particular focus on airway neutrophils.

Interventions

A group of adult asthmatics (recruited through general practice and advertisement) will be asked if they are amenable to a tailored change in their current asthma treatment. Change in treatment will be made on an individual basis by the supervising clinician according to the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 (EPR 3) guidelines, in which asthma control status is based on asthma control questionnaire (ACQ) 7 score, An ACQ-7 score <0.75 will be considere

A group of adult asthmatics (recruited through general practice and advertisement) will be asked if they are amenable to a tailored change in their current asthma treatment. Change in treatment will be made on an individual basis by the supervising clinician according to the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 (EPR 3) guidelines, in which asthma control status is based on asthma control questionnaire (ACQ) 7 score, An ACQ-7 score <0.75 will be considered adequately controlled, ACQ-7 >1.5 will be considered inadequately controlled. Once asthma control status/treatment has been ascertained, participants will undergo a clinical assessment (including sputum induction). Group 1: Subjects with adequately controlled asthma (as determined on initial visit) will have their current treatment sub-optimised to a reduced dose of their currently used inhaled corticosteroids (ICS) or to no ICS. The reduction in ICS dose will discussed and agreed with the participant, and will be between 250-1000 mcg budesonide equivalent dose per day. They will then be monitored over a 4-6 week period by weekly review appointments and phone calls (as required) with the supervising physician to assess symptoms, lung function, adherence to ICS dose, and loss of control (based on the criteria of Jone SL et al, Am J Resp Crit Care Med 2001; 164; 738-743). Briefly, this includes the onset of distressing or intolerable asthma symptoms, night wakening with asthma symptoms on more than 3 nights per week, or increase in bronchodilator use of >3 puffs daily. After the 4-6 week period, participants will undergo a further clinical assessment (including sputum induction). Group 2: Subjects with inadequately controlled asthma (as determined on initial visit) will have their treatment optimised and either commence ICS use or increase their current ICS dose. The increase in ICS dose will discussed and agreed with the participant, and will be between 250-1000 mcg budesonide equivalent dose per day. They will then be monitored over a 4-6 week period by weekly review appointments and phone calls (as required) with the supervising physician to assess symptoms, lung function, adherence to ICS dose, and changes in asthma control (as described for group 1), and then undergo a further clinical assessment (including sputum induction). As this is a pilot/feasibility study, the duration between assessments (4-6 weeks) will be flexible and based on the availability of both participant and research team. All participants will continue to use short-acting beta-agonists (SABA) as required, and at the end of the study/time of the second sputum induction, asthma treatment will be adjusted for all subjects according to their asthma control.

Sponsors

Centre for Public Health Research, Massey University.
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
17 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for asthmatics: physicians diagnosis of asthma, history of wheeze in last 12 months or asthma medication use in the last 12 months, FEV1>75% predicted, Inclusion criteria for non-asthmatics: No previous or current diagnosis of asthma, no history of wheeze or nocturnal cough in the last 12 months, FEV1>75% predicted.

Exclusion criteria

Both asthmatics and non-asthmatics: Respiratory tract infection/symptoms in the 4 weeks preceding recruitment, a history of chronic or immune system disease other than asthma, FEV1<75% predicted,

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026