Clinical consequences of Aspergillus disease in cystic fibrosis

Clinical consequences of Aspergillus colonisation and disease in cystic fibrosis and the role of environment in acquisition and infection

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16364688

Enrollment

110

Registered

2018-03-22

Start date

2018-01-01

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Pulmonary Aspergillus disease in patients with cystic fibrosis Respiratory

Interventions

Patients involved in the previous trial which classified aspergillus disease by phenotype (REC ref: 07/Q1403/70) will followed up to the current day to monitor clinical outcomes and clinical decline,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients will have taken part in study REC ref: 07/Q1403/70 between 2008-2011 (number = 129). Surviving patients who have not received a lung transplant or moved away from the unit since that time will be eligible for prospective reclassification of Aspergillus disease. All 129 patients will be followed up for retrospective data. 1. Cystic fibrosis patients > 18 years old, both male and female 2. Patients who have taken part in study REC ref: 07/Q1403/70 3. Patients eligible for reclassification of Aspergillus disease if not undergone lung transplantation or not moved away from area

Exclusion criteria

Exclusion criteria: 1. Non cystic fibrosis patients 2. Patients not involved in study REC reference number 07/Q1403/70 3. Patients who have undergone lung transplantation 4. Patients who have moved away from the area during follow-up time from original study

Design outcomes

Primary

Measure	Time frame
1. Diagnosis of Aspergillus phenotype by means of blood test for Aspergillus IgE, Aspergillus IgG, Total IgE and Galactomannan, along with a sputum sample for Aspergillus, both at baseline . This is compared to previous phenotype diagnosed in study REC ref: 07/Q1403/70 to establish if change in disease class has occurred 2. Comparison of survival outcomes between class 1-4 of Aspergillus disease (present day snapshot of the patient population), and rate of clinical decline (marked by FEV1 % predicted and BMI measurements taken yearly)	—

Measure

Time frame

1. Diagnosis of Aspergillus phenotype by means of blood test for Aspergillus IgE, Aspergillus IgG, Total IgE and Galactomannan, along with a sputum sample for Aspergillus, both at baseline . This is compared to previous phenotype diagnosed in study REC ref: 07/Q1403/70 to establish if change in disease class has occurred 2. Comparison of survival outcomes between class 1-4 of Aspergillus disease (present day snapshot of the patient population), and rate of clinical decline (marked by FEV1 % predicted and BMI measurements taken yearly)

—

Secondary

Measure	Time frame
Aspergillus/fungal exposure at a patient's residence, determined by environmental sampling at baseline. This will supplement data collected as part of air quality surveys undertaken in the cystic fibrosis unit, both in inpatient and outpatient areas	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026