A study to determine the eight-week longitudinal variation in serum periostin levels in a population with stable asthma.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000235606

Acronym

PER02

Enrollment

Registered

2014-03-05

Start date

2014-03-10

Completion date

2015-02-16

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Levels of POSTN (a protein-coding gene, also known as osteoblast specific factor) gene expression and periostin have been measured in a number of tissues and disease states, including asthma. As yet an incomplete picture is currently available on the role and effects of periostin level in the blood, however it has shown promise as a biomarker for asthma severity and a marker of inflammation levels, being easy to measure through a simple blood test. This study of the longitudinal variation of periostin in patients with stable asthma would provide further information on the production of periostin in asthma. Until now the periostin assay has only been used to determine the relationship of periostin with eosinophilic airway inflammation in patients not responding to inhaled steroid treatment and has not been studied in patients with stable, well controlled asthma. This study is part of a programme of research being undertaken by the Medical Research Institute of New Zealand, aimed at furthering knowledge of periostin, in order to discover its clinical usefulness.

Interventions

Serum Periostin levels Serum Periostin levels will be measured at 11 visits (Days 1 [enrolment visit], 2, 3, 4, 5, 10, 17, 24, 31, 38 and 59) via a specific periostin laboratory assay.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Aged between 18 to 75 years Able to provide written informed consent Doctor diagnosis of asthma On a stable asthma treatment regime for greater than or equal to 3 months prior to visit 1, taking regular inhaled medication for asthma (including maintenance inhaled corticosteroid and long acting beta agonists)

Exclusion criteria

Unstable asthma (as determined by the investigator and/or a change in asthma medication in last 3 months) Oral or Systemic Corticosteroids within the last 3 months Known Pregnancy Significant co morbidities (determined at investigator discretion) Hospital admission within last 3 months Surgery within last 3 months, determined at investigator discretion (this includes all major surgery requiring general anaesthetic, dental extractions and root canal procedures. This does not include minor procedures, including but not limited to mole or wart removal, dental fillings etc). Bone fracture within the last 3 months Active (current, or within the 3 weeks prior to the visit) upper or lower respiratory tract infection Any other safety concern at the investigator’s discretion

Outcome results