Trial Outcomes & Findings for Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis (NCT NCT02083263)

Results Overview

Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

up to 3 months

Results posted on

2014-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Bilevel Bilevel, 3 months Bilevel: 3 months	PEP Mask PEP mask, 3 months PEP mask: 3 months
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilevel n=16 Participants Bilevel, 3 months Bilevel: 3 months	PEP Mask n=16 Participants PEP mask, 3 months PEP mask: 3 months	Total n=32 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 11 • n=5 Participants	33 years STANDARD_DEVIATION 9 • n=7 Participants	31 years STANDARD_DEVIATION 10 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Sweden	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 months

Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.

Outcome measures

Outcome measures
Measure	Bilevel n=16 Participants Bilevel, 3 months Bilevel: 3 months	PEP Mask n=16 Participants PEP mask, 3 months PEP mask: 3 months
Lung Function: Lung Clearance Index	9 lung clearance index Standard Deviation 3	9.7 lung clearance index Standard Deviation 3

SECONDARY outcome

Timeframe: 1 month

After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.

Outcome measures

Outcome data not reported

Adverse Events

Bilevel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PEP Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Cecilia Rodriguez Hortal

Karolinska University Hospital

Phone: 0046709558699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place