Non-Invasive Ventilation in Amyotrophic Lateral Sclerosis

NCT00560287 | Unknown Phase 4 DMC

• 1 other identifier: 190H09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Non-invasive mechanical ventilation (NIV) has been increasingly used as a treatment of chronic hypercapnic respiratory failure. Its use in patients affected by chronic obstructive pulmonary disorders is still controversial, while most of the studies performed in restrictive thoracic disorders (RTD), and in particular in neuromuscular patients, suggested alleviation of the symptoms of chronic hypoventilation in the short term, and in two small studies survival was prolonged. In the terminal phase of the disease, when the respiratory muscles became weaker it is very likely that the operators need to frequently adjust the level of inspiratory pressure in an attempt to guarantee an adequate tidal volume, so that alveolar hypoventilation may be avoided. Theoretically the use of a volume assisted ventilation may overpass this problem of frequent variations of the settings, since the provision of a fixed tidal volume may always guarantee and adequate alveolar ventilation. The primary aims of this multicenter randomized study are to evaluate the clinical efficacy, the patients' tolerance and quality of life and the frequency of changing settings in a group of patients with SLS and initial chronic respiratory failure undergoing long-term NIV with Pressure Support Ventilation or Volume Assisted Ventilation.

Conditions

Amyotrophic Lateral Sclerosis; Chronic Respiratory Failure

Keywords

Amyotrophic Lateral Sclerosis; Non-invasive ventilation; Chronic Respiratory Failure

Outcome Measures

Primary Outcomes (5)

• quality of life

  1 year

• tolerance to NIV

  1 year

• number of hours of NIV per day

  1 year

• frequency of hospital admission

  1 year

• frequency of changing the ventilator settings by the operator.

  1 year

Secondary Outcomes (3)

• survival

  1 year

• diurnal and nocturnal gas exchange

  1 year

• Pulmonary Function Tests (PFTs).

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Volume assist non-invasive ventilation

Device: Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers; Device: Non invasive ventilation

2

ACTIVE COMPARATOR

Pressure Assist mode

Device: Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers; Device: Non invasive ventilation

Interventions

Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers DEVICE

A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.

Also known as: Legendaire (Airox), Vivo (Breas), Elisee (Saime), Synchrony (Respironics)

1; 2

Non invasive ventilation DEVICE

A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.

Also known as: Legendaire (Airox), Vivo (Breas), Elisee (Saime), Synchrony (Respironics)

1; 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the diagnosis of ALS and one of the following signs:
• Vital Capacity \< 50% predicted
• A Maximal Inspiratory Pressure (MIP) \< 60% predicted
• Polygraphic signs of nocturnal hypoventilation with daytime symptoms.

You may not qualify if:

• Life expectancy\>12 months
• Any comorbidity
• Acute Respiratory Failure

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (2)

Fondazione S.Maugeri

Pavia, 27100, Italy

RECRUITING

Respiratory Unit FSM

Pavia, 27100, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Stefano Nava

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

• Stefano Nava, MD

  Fondazione S.maugeri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Nava, MD

CONTACT

0382 592; snava@fsm.it

Franco Fanfulla, MD

CONTACT

0382 592; ffanfulla@fsm.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2010
• Last Updated: March 29, 2010

Record last verified: 2010-03

Locations

IT (2)