Trial Outcomes & Findings for Elucidation of Acid-Induced Pulmonary Inflammation (NCT NCT00361972)

Results Overview

Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

17 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2016-08-05

Participant Flow

in clinics over 18 month period

washout after lansoprazole or placebo given

Participant milestones

Participant milestones
Measure	Lansoprazole lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks	Placebo placebo comparator to lansoprazole, 30 mg, twice a day for 6 weeks
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Elucidation of Acid-Induced Pulmonary Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lansoprazole n=8 Participants lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks	Placebo n=9 Participants placebo comparator to lansoprazole 30 mg twice daily for 6 weeks	Total n=17 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	43 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.

Outcome measures

Outcome measures
Measure	Lansoprazole n=8 Participants lansoprazole: 30 mg lansoprazole twice daily for 6 weeks	Placebo n=9 Participants placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
Change in Lymphocyte Count	-57 Lymphocytes per square millimeter Standard Deviation 10	-3 Lymphocytes per square millimeter Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention.

Outcome measures

Outcome measures
Measure	Lansoprazole n=8 Participants lansoprazole: 30 mg lansoprazole twice daily for 6 weeks	Placebo n=9 Participants placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement	0.4 log (pg/mL) Interval -1.4 to 1.5	2.0 log (pg/mL) Interval -1.6 to 5.6

Adverse Events

Lansoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

kathryn peterson

university of utah

Phone: 8015817804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place