Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis

• Status: Withdrawn
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Bronchiectasis is a common chronic lung condition where patients have permanent airways damage leading to daily symptoms of cough, sputum production and recurrent respiratory tract infections.

Preliminary studies in our research group have found a severe deficiency of the immune system as a rare cause of bronchiectasis (called immunoglobulin G subclass 2 deficiency) and occurs in about 1 in 20 bronchiectasis patients. The pilot work shows that these patients have more chest infections and their lung function deteriorates more rapidly.

There are no trials to date to guide doctors to decide whether we should replace this deficiency from donated blood or not. The aim with treatment is to prevent disease progression and avoid the need for long term antibiotics.

This trial will help us understand how this treatment works and its acceptability to patients. This study will help us decide whether investigators should pursue future formalised trials in many centres throughout the UK and how investigators should evaluate such a treatment.

We are looking to recruit 20 patients to this study 10 of which will receive weekly replacement therapy and the remaining 10 will receive standard care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborator: NHS Lothian
• Treatments: Antibodies; Immunoglobulin G; Immunoglobulins

Criteria

Inclusion criteria (need to meet all criteria below)

1. Bronchiectasis as the primary respiratory diagnosis.

2. Aged 18 years or older.

3. Bronchiectasis Severity Index >5 (0-4 mild; 5-8 moderate; >9 severe) or 3 or more exacerbations in the preceding year.

4. Patients with IgG2 deficiency<2.41g/L.

5. Able to provide written, informed consent

6. In the opinion of the research physician, the patient will be able to comply with the requirements of the trial protocol

7. Meets the co-enrolment criteria

Exclusion criteria (will be excluded if they have any item below)

1. Cystic fibrosis

2. Pregnancy or breast feeding

3. Women of childbearing potential not taking appropriate contraception. Acceptable contraception in women of childbearing age is a "highly effective" contraceptive measure as defined by the Clinical Trials Facilitation Group (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/ 2014_09_HMA_CTFG_Contraception.pdf) and includes combined (oestrogen and progesterone containing) or progesterone-only contraception associated with inhibition of ovulation, or intrauterine device or bilateral tubal occlusion. Contraception must be continued for a minimum of 30 days after the end of the IMP dosing schedule.

4. Active malignancy

5. Active co-morbid illness

6. Current smokers or ex-smokers less than 1 year

7. Known hypersensitivity to L-proline or Polysorbate 80

8. Known hyperprolinaemia type I or II

9. Known hypersensitivity to the IMP active substance or excipients (i.e. human normal immunoglobulin, Glyine or water for injections).

10. Severe IgA deficiency and a history of hypersensitivity to human immunoglobulin treatment

11. Known IgG1 deficiency

12. Known thrombophilic disorders or thrombotic events

13. Previously participated in this trial

14. Severe renal impairment (creatinine clearance of less than 30 ml/minute)