Trial Outcomes & Findings for Respiratory Impedance and Obliterative Bronchiolitis (NCT NCT01255449)

Results Overview

We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

2 weeks before and 2 months after HSCT

Results posted on

2013-01-31

Participant Flow

The recruitment started on 10-Nov-2010 and finished on 15-feb-2012. The recruitment was performed at Pulmonary Function Tests Laboratory of IRCCS AOU San Martino.

All patients were in stable clinical conditions and none had a history of significant respiratory disease.

Participant milestones

Participant milestones
Measure	Albuterol On each study day, all lung function measurements were taken before and 30 min after inhaling four consecutive albuterol doses of 100 mcg each, through a valved-holding chamber. Lung diffusing capacity for carbon monoxide was measured only after bronchodilator inhalation.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiratory Impedance and Obliterative Bronchiolitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albuterol n=26 Participants All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	37 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Italy	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks before and 2 months after HSCT

We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC)

Outcome measures

Outcome measures
Measure	Airway Distensibility With Lung Inflation After HSCT n=26 Participants Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)	0.07 1/cmH2O*s Standard Deviation 0.10

SECONDARY outcome

Timeframe: Before and 2 months after HSCT

Population: CT scans, in a format suitable for software analysis, were available in 8 patients only

Changes in lung tissue density were measured by quantitative computed tomography(CT) scan 2 weeks before and 2 months after HSCT

Outcome measures

Outcome measures
Measure	Airway Distensibility With Lung Inflation After HSCT n=8 Participants Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
Post-HSCT Changes in Lung Tissue Density	0.03 g/mL Standard Deviation 0.02

Adverse Events

Albuterol

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

Dr. Giovanni Barisione

IRCCS Azienda Ospedaliera Universitaria San Martino IST - Genova, Italy

Phone: +39010555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place