Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Non-Invasive Ventilation (NIV) For Positive Pressure Support. A Randomised Cross-Over Trial To Evaluate The Short-Term Effects of NIV As An Adjunct To Airway Clearance Techniques in Adults With Cystic Fibrosis.
Brief Summary: Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is very difficult to clear, which can results in recurrent chest infections, which can lead to lung damage. therefore it is important to optimise the removal of sputum to try and prevent these complications. Traditionally, a variety of approaches are usually combined including inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise secretions and improve sputum clearance.

There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. When people with CF have an infection or have severe disease often the effectiveness of ACTs can decrease due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy.

At present no research studies have reported an increase in sputum cleared with the addition of positive pressure, however it is thought that the ability to take a deeper breath when using positive pressure would help to improve sputum clearance. With clinical experience of the use of NIV with adult CF patients, the investigators aim to explore this objectively in this study.

Research Question:

Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis?

Hypothesis

The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.


Options:
A: Arm Label: 1. Exercise testing and self drainage session; Type: EXPERIMENTAL; Interventions: Procedure: Chest physiotherapy | Arm Label: 2. Chest physiotherapy (CP) session; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Chest physiotherapy | Intervention Type: PROCEDURE; Name: Chest physiotherapy; Assigned to Arm(s): 1. Exercise testing and self drainage session, 2. Chest physiotherapy (CP) session
B: Arm Label: Normal airway clearance; Type: EXPERIMENTAL; Interventions: Other: Airway Clearance Techniques | Arm Label: Non-Invasive Ventilation; Type: EXPERIMENTAL; Interventions: Other: Airway Clearance Techniques | Intervention Type: OTHER; Name: Airway Clearance Techniques; Assigned to Arm(s): Non-Invasive Ventilation, Normal airway clearance
C: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])
D: Arm Label: USUAL CARE; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: INHALATION WITH PEP DEVICE; Type: ACTIVE_COMPARATOR; Interventions: Device: INHALATION WITH PEP DEVICE (Acapella Duet) | Intervention Type: DEVICE; Name: INHALATION WITH PEP DEVICE (Acapella Duet); Assigned to Arm(s): INHALATION WITH PEP DEVICE

Answer: B