A 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
- Conditions
- Primary Immunodeficiency
- Interventions
- Device: Generic Syringe then Chrono Super PID-GammanormDevice: Chrono Super PID then Generic Syringe-Gammanorm
- Registration Number
- NCT02503293
- Lead Sponsor
- Octapharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
• Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Generic Syringe then Chrono Super PID - Gammanorm Generic Syringe then Chrono Super PID-Gammanorm 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 Chrono Super PID then Generic Syringe - Gammanorm Chrono Super PID then Generic Syringe-Gammanorm 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
- Primary Outcome Measures
Name Time Method To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used. Participants will be followed for a total of 6 months 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.
- Secondary Outcome Measures
Name Time Method To compare the other quality of life scores Participants will be followed for a total of 6 months 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
Trial Locations
- Locations (12)
CampbelltownHospital
🇦🇺Campbelltown, Australia
Canberra Hospital
🇦🇺Canberra, Australia
University Medical Centre Freiburg
🇩🇪Freiburg, Germany
Municipal Hospital "St. Georg"
🇩🇪Leipzig, Germany
Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
🇮🇹Rome, Italy
Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
🇮🇹Padova, 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
John Radcliff Hospital
🇬🇧Oxford, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom