Clinical trial NCT02982876: Airway Stents for Excessive Dynamic Airway Collapse
Official title: Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tracheobronchomalacia
Excessive Dynamic Airway Collapse
Keywords: Silicone Airway stent
Metallic Airway stent
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: American Association of Broncology and Interventional Pulmonology
name: Curetbm.org Fundation
name: Hood Laboratories
name: Boston Medical products inc
First posted: 2016-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Airway stents are used as standard of care to identify which patients with excessive dynamic airway collapse will benefit from a definitive surgical treatment. However, the specific way in which these stents are effective has not been tested. The purpose of this research study is to determine the effectiveness of airway stents when used in the airways of patients with severe symptomatic excessive dynamic airway collapse compared to patients with severe symptomatic excessive dynamic airway collapse that do not receive airway stent.

Detailed description: Study Design

This randomized controlled trial will be conducted at Beth Israel Deaconess Medical Center (BIDMC) in accordance with Good Clinical Practice Standards and under IRB supervision. We plan to enroll total of 48 patients with EDAC randomized by a computer generated system to either intervention group (airway stent) or medical management group.

Description of the study

Previous to appointment all patients will have Airway CT scan, 6 minute walk test and pulmonary function test as per protocol and standard of care.

Enrollment

Patients with severe EDAC who remain symptomatic despite optimal medical management will be informed about the trial and if interested will be recruited for the study.

Operative Technique

Patients in the treatment group (stent) will undergo bronchoscopy under light sedation and rigid bronchoscopy under general anesthesia. The treatment group will undergo a bronchial wash and placement of an airway stent.Patients assigned to the medical management group will not undergo bronchoscopy.

Stents

Based on the patient's airway anatomy an uncovered self-expanding metallic stent (Ultraflex™ Single-Use Tracheobronchial Stent System) or a silicone Y-stent(Endoxane, Novatech S.A., Aubagne-France or Channick Hood Laboratories, Pembroke, MA, 02359) will be used in the study.

During Stent Trial

After bronchoscopy, patients in the treatment group will receive a standardized medication regimen to include mucolytics, cough suppressors and expectorants in order to decrease the risk of potential complications following the procedure.

Follow-up

All participants will be scheduled for a follow-up visit in the following 14 days either after rigid bronchoscopy (treatment group) or after first visit (medical management group) with 6MWTs and PFTs. In this visit all patients will be asked to complete the SGRQ, CQLQ and mMRC questionnaires by the research team. All this data will be recorded in an encrypted database. Afterwards, the patients in the medical management arm will be offered a stent trial as part of standard of care.

Stent removal

The patients from the treatment arm will be scheduled for a rigid bronchoscopy, stent removal and bronchial lavage under anesthesia in the operating room.

Eligibility criteria: Inclusion Criteria:

* Patient with sever symptomatic EDAC (collapse \>90% of the airway during exhalation at dynamic CT scan)
* Age \> 18 years

Exclusion Criteria:

* Patients who have not been well managed from their respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis)
* Current respiratory infection
* Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
* Dysrhythmia that might pose a risk during exercise or training
* Any disease or condition that interferes with completion of initial or follow-up assessments

Primary outcomes:
measure: St. George's Respiratory Questionnaire
timeFrame: 7-14 days
Secondary outcomes:
measure: modified Medical Research Council scale of dyspnea
timeFrame: 7-14 days
measure: Cough Quality of life Questionnaire
timeFrame: 7-14 days
measure: 6 minute walk test
timeFrame: 7-14 days
measure: FEV1
timeFrame: 7-14 days
measure: Peak flow
timeFrame: 7-14 days
measure: Self-reported symptoms
timeFrame: 7-14 days
measure: Complications
timeFrame: 7-14 days
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Adnan Majid, MD
role: PRINCIPAL_INVESTIGATOR
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