Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Timing of Hypertonic Saline Inhalation Relative to Airways Clearance in Cystic Fibrosis
Brief Summary: Lung disease is the predominant cause of morbidity and mortality in Cystic Fibrosis (CF) with 80% of deaths resulting directly or indirectly from pulmonary disease. Abnormal airway clearance causes retention of mucus resulting in frequent chest infections. Physiotherapists use different techniques to help clear mucus from the lungs of patients with CF. Inhaled medications and airways clearance techniques (ACTs) are central to a CF patient's daily treatment and are often coordinated.

Burden of treatment is a common reason for non-adherence in this patient group, and streamlining of treatment timings is sought to optimize adherence whilst ensuring efficacy to an often complex daily regimen of inhaled bronchodilators, nebulizers and ACTs. A gap in the research exists as to the optimal timing of Hypertonic Saline (HTS) and ACT within the daily regimen. A study to show whether the timing of HTS around ACT is significant, can better inform patients and potentially allow more flexibility around their treatment regimen.

Lung Clearance Index (LCI) has shown good sensitivity to abnormalities in lung function compared with spirometry and has demonstrated a treatment effect in other trials. LCI may be a suitable tool therefore, to assess intervention strategies aimed at airways clearance in CF. This study aims to compare the effects ACTs after HTS inhalation versus ACTs during HTS inhalation as measured by LCI.

It is a randomized, crossover trial of ACTs after HTS inhalation compared with ACTs during HTS inhalation in adult CF patients during day 10-14 of a hospital admission for treatment of a pulmonary exacerbation. Patients will be randomized to receive 1 of the treatment session options on the first day and the reverse on the second day.

The primary objective of this study is to compare the change in LCI (a measure of lung function) at 90 minutes post treatment with ACTs after HTS inhalation compared with ACTs during HTS inhalation in adult CF patients.

LCI (lung clearance index) ACT (airway clearance technique) HTS (hypertonic saline)


Options:
A: 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])
B: 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
C: Arm Label: Usual Airway Clearance Technique; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual airway clearance | Arm Label: High Frequency Chest Wall Oscillation (HFCWO); Type: EXPERIMENTAL; Interventions: Device: High Frequency Chest Wall Oscillation (HFCWO) | Intervention Type: DEVICE; Name: High Frequency Chest Wall Oscillation (HFCWO); Assigned to Arm(s): High Frequency Chest Wall Oscillation (HFCWO) | Intervention Type: OTHER; Name: Usual airway clearance; Assigned to Arm(s): Usual Airway Clearance Technique
D: Arm Label: ACTs after HTS inhalation:; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Airways clearance and Hypertonic saline inhalation | Arm Label: ACTs during HTS inhalation; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Airways clearance and Hypertonic saline inhalation | Intervention Type: PROCEDURE; Name: Airways clearance and Hypertonic saline inhalation; Assigned to Arm(s): ACTs after HTS inhalation:, ACTs during HTS inhalation

Answer: D