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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518821-13-00 | EU Trial (CTIS) Number |
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This study is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose range finding study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (immunoglobulin G [IgG] inhalation solution) compared with placebo over a period of 6 to 12 months independent of the occurrence of pulmonary exacerbations.
The primary aim of the study is to characterize the overall effect of CSL787 as well as the dose response of 2 active treatment regimens of inhaled CSL787 administered to participants with NCFB toward prolonging the TTF exacerbation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL787 High Dose | Experimental | Participants in this arm will receive a high dose of CSL787. |
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| CSL787 Low Dose | Experimental | Participants in this arm will receive a low dose of CSL787. |
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| Placebo | Placebo Comparator | Participants in this arm will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL787 | Biological | CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first (TTF) Exacerbation | TTF exacerbation, where an exacerbation is defined as a deterioration in >= 3 of the following symptoms for >= 48 hours: cough; sputum volume and / or consistency; sputum purulence; breathlessness and / or exercise tolerance; fatigue and / or malaise; hemoptysis AND a clinician determines that antibiotic therapy is required. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per-participant Year) | Up to Month 12 | |
| Number of Participants Achieving a Clinically Important Difference in the Quality of Life-Bronchiectasis (QoL-B) Respiratory Symptoms Scale | The QoL-B questionnaire is a self-administered measure assessing symptoms, functioning, and health-related quality of life for patients with NCFB. This questionnaire contains 37 items on 8 different scales (Respiratory symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions, and Treatment Burden). For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. |
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Inclusion Criteria:
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Registration Coordinator | Contact | +1 610-878-4697 | clinicaltrials@cslbehring.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Recruiting | Queensland | Australia | |||
| Westmead Hospital |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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This is a randomized, double-blind, parallel-group, placebo-controlled study.
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| Placebo | Drug | Participants will receive a matching volume of placebo QD over a period of 6 to 12 months. |
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| Nebulizer | Device | The nebulizer is a CE-marked device. |
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| Up to Month 12 |
| Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale | The QoL-B questionnaire is a self-administered measure assessing symptoms, functioning, and health-related quality of life for patients with NCFB. This questionnaire contains 37 items on 8 different scales (Respiratory symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions, and Treatment Burden). For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. | Up to Month 12 |
| Change From Baseline in QoL-B Respiratory Symptoms Scale | The QoL-B questionnaire is a self-administered measure assessing symptoms, functioning, and health-related quality of life for patients with NCFB. This questionnaire contains 37 items on 8 different scales (Respiratory symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions, and Treatment Burden). For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. | From Baseline to Months 6 and 12 |
| Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria Isolated from Sputum | From Baseline to Month 1 |
| Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs) | Up to Month 13 |
| Percentage of Participants with TEAEs and SAEs | Up to Month 13 |
| Recruiting |
| Westmead |
| Australia |
| Fukuoka University Chikushi Hopsital | Recruiting | Chikushino-shi | Japan |
| Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers | Recruiting | Fukuoka | Japan |
| Ibaraki Prefectural Central Hospital | Recruiting | Ibaraki | Japan |
| Kazunori Tobino Iizuka Hospital | Recruiting | Iizuka-shi | Japan |
| National Hospital Organization Minami Kyoto Hospital | Recruiting | Kyoto | Japan |
| Matsusaka Municipal Hospital | Recruiting | Mie | Japan |
| National Hospital Organization Kinki Chuo Chest Medical Center | Recruiting | Osaka | Japan |
| Shimonoseki City Hospital | Recruiting | Shimonoseki-shi | Japan |
| Japan Anti-Tuberculosis Association, Fukujuji Hospital | Recruiting | Tokyo | Japan |
| Keio University Hospital | Recruiting | Tokyo | Japan |
| National Hospital Organization Mie Chuo Medical Center | Recruiting | Tsu | Japan |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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