Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure

NCT02763631 | Completed

• 1 other identifier: 16/LO/0028
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the benefit of a portable ventilator generating positive end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM).

Conditions

Excessive Dynamic Airway Collapse; Tracheobronchomalacia

Outcome Measures

Primary Outcomes (1)

• Does daytime activity by an accelerometer change from baseline to 4 weeks

  Daytime activity assessed by an accelerometer. Participants will be assessed at baseline and at 4 weeks in the control arm and in the treatment arm with participants on portable CPAP to see if there is any change between the time frames and between the groups on daytime activity measured by accelerometers that all participants randomised into the trial will wear from baseline to follow up at 4 weeks.

  4 weeks

Secondary Outcomes (6)

• Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up

  4 weeks

• Change in respiratory-related quality of life - Severe Respiratory Insufficiency (SRI)

  4 weeks

• Change in respiratory-related quality of life - St George's Respiratory Questionnaire (SGRQ)

  4 weeks

• Change in neural respiratory drive with parasternal electromyography

  4 weeks

• Change of lung homogeneity assessed by electrical impedance tomography while on CPAP

  4 weeks

Study Arms (3)

Run In Phase

EXPERIMENTAL

Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP

Other: Experimental: Run In Phase

Treatment

EXPERIMENTAL

Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either: Treatment arm - Patients will be setup onto portable CPAP during the day

Other: Experimental: Treatment

Standard Care Arm

SHAM COMPARATOR

Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either: Control Arm - Standard care arm.

Other: Sham Comparator: Stand Care Arm

Interventions

Experimental: Treatment OTHER

Participants will be established on portable CPAP during the day with nasal pillows as an interface and requested to use it at least 8 hours/day.

Treatment

Experimental: Run In Phase OTHER

Participants will undergo a run-in phase during which they will undergo baseline assessments. If they tolerate the portable CPAP and if their 6-MWT improves by more than 30m when performed on CPAP, they will be randomised into the trial.

Run In Phase

Sham Comparator: Stand Care Arm OTHER

No change will be made to participants care

Standard Care Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with diagnosed EDAC or TBM on inspiratory/expiratory CT or bronchoscopy
• Patient with exertional dyspnea

You may not qualify if:

• Pregnancy
• Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
• Inability to perform 6-MWT
• Current intra-tracheal stent
• Previous surgery for EDAC or TBM
• Uncontrolled underlying disease:
• Initiation of home mechanical ventilation in last 3 months
• Uncontrolled joint pain

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• B&D Electromedical: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Tracheobronchomalacia

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nick Hart

  Guy's and St Thomas' NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 5, 2016
• Study Start: September 1, 2016
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)