A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Each patient will receive the study treatment of Gammanorm using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • pump and then syringe The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back). Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection
Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • syringe and then pump. The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back). Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection
CampbelltownHospital
Campbelltown, Australia
Canberra Hospital
Canberra, Australia
University Medical Centre Freiburg
Freiburg im Breisgau, Germany
To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used.
Each patient will be treated for two consecutive periods of three months each according to the sequence assigned based on the cross-over design (syringe and then pump, or pump and then syringe) without any intermediate washout period. The total duration of study treatment will therefore be 6 months for each patient. Assessment will be conducted via the LQI scale.
Time frame: Participants will be followed for a total of 6 months
To compare the other quality of life scores
Each patient will be treated for two consecutive periods of three months each according to the sequence assigned based on the cross-over design (syringe and then pump, or pump and then syringe) without any intermediate washout period. The total duration of study treatment will therefore be 6 months for each patient. Assessment will be conducted via the LQI scale factors II and III Patient quality of life will be assessed via SF-36 scale. Patient satisfaction will be assessed via TSQM-11 scale
Time frame: Participants will be followed for a total of 6 months
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Municipal Hospital "St. Georg"
Leipzig, Germany
Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
Padova, Italy
Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
Rome, Italy
University Hospitals Birmingham
Birmingham, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
- The Royal London Hospital
London, United Kingdom
The Royal Free
London, United Kingdom
...and 2 more locations