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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chrono Super PID then Generic Syringe - Gammanorm | Other | 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: • Chrono Super PID then Generic Syringe-Gammanorm |
|
| Generic Syringe then Chrono Super PID - Gammanorm | Other | 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: • Generic Syringe then Chrono Super PID-Gammanorm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chrono Super PID then Generic Syringe-Gammanorm | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for a total of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion Criteria:
• Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Warnatz, MD | Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CampbelltownHospital | Campbelltown | NSW 2560 | Australia | |||
| Canberra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22956859 | Background | Kobrynski L. Subcutaneous immunoglobulin therapy: a new option for patients with primary immunodeficiency diseases. Biologics. 2012;6:277-87. doi: 10.2147/BTT.S25188. Epub 2012 Aug 24. | |
| 17402794 | Background | Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105-16. doi: 10.2165/00063030-200721020-00005. |
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|
|
| Generic Syringe then Chrono Super PID-Gammanorm | Device | 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 |
|
|
| Participants will be followed for a total of 6 months |
| Canberra |
| ACT 2605 |
| Australia |
| University Medical Centre Freiburg | Freiburg im Breisgau | D-79106 | Germany |
| Municipal Hospital "St. Georg" | Leipzig | D-04129 | Germany |
| Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica | Padova | 35128 | Italy |
| Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology | Rome | 00161 | Italy |
| University Hospitals Birmingham | Birmingham | B15 2GW | United Kingdom |
| University Hospital of Wales | Cardiff | CF144XW | United Kingdom |
| - The Royal London Hospital | London | E12ES | United Kingdom |
| The Royal Free | London | NW3 2QG | United Kingdom |
| John Radcliff Hospital | Oxford | OX3 9DU | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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