Targeted Lung Denervation for Patients With Moderate to Severe COPD (AIRFLOW)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02058459|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2014
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Device: Holaira™ Lung Denervation System with energy delivery Device: Holaira™ Lung Denervation System without energy delivery||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.|
|Study Start Date :||August 4, 2014|
|Actual Primary Completion Date :||January 26, 2018|
|Estimated Study Completion Date :||July 31, 2021|
Active Comparator: Targeted Lung Denervation
active targeted lung denervation
Device: Holaira™ Lung Denervation System with energy delivery
Sham Comparator: Sham-Control
non-active targeted lung denervation
Device: Holaira™ Lung Denervation System without energy delivery
- AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months [ Time Frame: 3-6.5 months ]Respiratory adverse events is defined as: worsening bronchitis, worsening dyspnea, common cold, COPD exacerbation, influenza, pneumonia, respiratory infection, respiratory failure, tachypnea and wheezing. Subjects may have reported more than one type of respiratory adverse event.
- Adverse events over 3 years [ Time Frame: 3 years ]The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin.
- Device Success [ Time Frame: 6 months ]Device success is defined as ability to deliver the test device to its intended locations, provide complete circumferential treatment and removal of the test device without the report of an adverse event during the procedure.
- Spirometry measures [ Time Frame: 3 years ]Measures include: FEV1, FVC, FEV1/FVC
- Change in Functional testing: Cycle Ergometry & 6MWT [ Time Frame: 3 years ]
- Heath-related Quality of Life (SGRQ-C & EQ-5D) [ Time Frame: 3 years ]
- Procedure Success [ Time Frame: Through discharge ]Procedure Success is defined as device success without the report of an adverse event through hospital discharge.
- Plethysmography measures [ Time Frame: 3 years ]Measures include Raw, TLC, IC, ITGW
- CT Scan assessment [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058459
|Principal Investigator:||Dirk-Jan Slebos, MD||University Medical Center Groningen|
|Principal Investigator:||Arschang Valipour, MD||Otto-Wagner-Spital|