Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation

Cystic Fibrosis Clinical Trial

Official title:

Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157183
• Other study ID #: 35/03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: December 4, 2013
• Start date: March 2003
• Est. completion date: March 2006

Study information

• Verified date: September 2005
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether correction of low nighttime oxygen (O2) levels and/ or high carbon dioxide levels in patients with cystic fibrosis improves their quality of life. The treatments being used overnight are (1)O2 (2)pressurised air which assists breathing (non-invasive positive pressure ventilation, NIPPV)

Description:

Cystic fibrosis is the commonest life-limiting genetic disorder in the Caucasian population with a median survival of 31 years. Lung disease is responsible for the majority of morbidity and mortality and correlates with declining quality of life. Respiratory failure is the primary cause of death. Daytime respiratory failure (hypoxia with pO2<55 and/or hypercapnia with pCO2>50) is associated with a worse prognosis with a 2-year survival of 50%. Nocturnal respiratory failure (greater than 5% of the night spent with SpO2<90% and/or rise in PtcCO2>10mmHg overnight) is a precursor to the development of daytime respiratory failure. It has been postulated that earlier treatment of respiratory failure may improve outcome and quality of life.

Intervention: Nocturnal O2 and bilevel NIPPV in CF patients with nocturnal respiratory failure, compared to nocturnal placebo (air). Crossover trial utilising patients as their own control.

Aims: (1) To assess the effects of non-invasive ventilation (NIV) and oxygen (O2) therapy on quality of life, hospital admission rate, sleep quality and exercise tolerance in CF patients with NRF (2) To identify a level of severity of NRF where treatment with NIV is effective

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

proven diagnosis cystic fibrosis, age 18 years or older, FEV1< 70% predicted normal, clinically stable (no admission or antibiotics last 2 weeks, OR end of admission where further clinical improvement not expected), nocturnal respiratory failure (SpO2<90% for > 10% of night or rise in PtcCO2 > 5 mmHg in REM), daytime hypercapnia (PaCO2> 45 mmHg)

Exclusion Criteria:

Previous home O2 or NIV use, Sedative medications, Cardiac/renal/endocrine/neurological disease likely to compromise ventilatory control

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Nocturnal oxygen , nocturnal bi-level positive pressure ventilation

Locations

Country	Name	City	State
Australia	The Alfred	Melbourne	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Bayside Health	Cystic Fibrosis Federation Australia, Monash University, National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life questionnaires:
Primary	CFQoL questionnaire (Gee,Thorax,2000)(a priori chest, physical function, treatment, emotion domains)
Primary	Epworth Sleepiness Scale
Primary	Pittsburgh Sleep Quality Index
Primary	CF Subjective Symptoms Sleep disturbance Questionnaire (CSQ-in house)
Primary	Medical Research Council Dyspnea Scale
Primary	Baseline Dyspnea Index, Transitional Dyspnea Index
Primary	Work or Study status
Primary	Physiological:
Primary	Nocturnal SpO2, nocturnal rise in transcutaneous CO2
Primary	Daytime arterial blood gases (PaCO2, PaO2)
Secondary	Admission rate
Secondary	Lung function tests (FEV1, FVC, RV/ TLC)
Secondary	Modified CF shuttle walk test
Secondary	Neurocognitive testing (psychomotor vigilance task, Stroop, Controlled Oral Word Association Test, Trails A and B, digit recall forwards backwards)
Secondary	PSG (sleep efficiency, arousal index, % REM sleep, urinary catecholamines)
Secondary	Serum cytokines (IL-6, TNF alpha, IL-1 beta)