Trial Outcomes & Findings for Efficacy of Lansoprazole in Chronic Post Nasal Drip (NCT NCT00335283)

Results Overview

The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

75 participants

Primary outcome timeframe

8 and 16 weeks

Results posted on

2012-08-21

Participant Flow

The PI and/or study coordinator or other GI research nurses will meet with the patients referred by Vanderbilt's Asthma, Sinus and Allergy Program. The patients will be given the consent form to read, the document will be reviewed, and all questions will be answered.

Participant milestones

Participant milestones
Measure	Lansoprazole 40 mg twice a day	Placebo (Sugar Pill) one tablet twice a day
Overall Study STARTED	36	39
Overall Study COMPLETED	30	34
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Lansoprazole in Chronic Post Nasal Drip

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lansoprazole n=36 Participants 40 mg twice a day	Placebo (Sugar Pill) n=39 Participants one tablet twice a day	Total n=75 Participants Total of all reporting groups
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	33 Participants n=5 Participants	36 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	46 years STANDARD_DEVIATION 15 • n=5 Participants	45 years STANDARD_DEVIATION 13 • n=7 Participants	45 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	26 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	39 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 and 16 weeks

Population: Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.

The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.

Outcome measures

Outcome measures
Measure	Lansoprazole n=30 Participants 40 mg twice a day	Placebo (Sugar Pill) n=34 Participants one tablet twice a day
Post Nasal Drainage Symptom Response 8 week	55 Scores on a Scale Interval 12.5 to 80.0	3.5 Scores on a Scale Interval 0.0 to 53.8
Post Nasal Drainage Symptom Response 16 week	50 Scores on a Scale Interval 10.0 to 72.0	5 Scores on a Scale Interval 0.0 to 40.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks, and 16 weeks

Population: Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.

RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.

Outcome measures

Outcome measures
Measure	Lansoprazole n=30 Participants 40 mg twice a day	Placebo (Sugar Pill) n=34 Participants one tablet twice a day
Rhinosinusitis Outcome Measure(RSOM-31) Baseline	63 Scores on a Scale Interval 50.0 to 93.0	51 Scores on a Scale Interval 38.0 to 69.0
Rhinosinusitis Outcome Measure(RSOM-31) 8 weeks	40 Scores on a Scale Interval 23.0 to 65.0	36 Scores on a Scale Interval 20.0 to 60.0
Rhinosinusitis Outcome Measure(RSOM-31) 16 weeks	35 Scores on a Scale Interval 21.0 to 61.0	35 Scores on a Scale Interval 23.0 to 55.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks and 16 weeks

Population: Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.

SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.

Outcome measures

Outcome measures
Measure	Lansoprazole n=30 Participants 40 mg twice a day	Placebo (Sugar Pill) n=34 Participants one tablet twice a day
Sino Nasal Outcome Test (SNOT-20) Baseline	36 Scores on a Scale Interval 31.0 to 52.0	35 Scores on a Scale Interval 31.0 to 45.0
Sino Nasal Outcome Test (SNOT-20) 8 weeks	25 Scores on a Scale Interval 17.0 to 35.0	32 Scores on a Scale Interval 17.0 to 39.0
Sino Nasal Outcome Test (SNOT-20) 16 weeks	20 Scores on a Scale Interval 19.0 to 40.0	27 Scores on a Scale Interval 16.0 to 38.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks and 16 weeks

Population: Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.

The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.

Outcome measures

Outcome measures
Measure	Lansoprazole n=30 Participants 40 mg twice a day	Placebo (Sugar Pill) n=34 Participants one tablet twice a day
Quality of Life Questionnaire (QOLRAD) Baseline	155 Scores on a Scale Interval 126.0 to 169.0	160 Scores on a Scale Interval 142.0 to 170.0
Quality of Life Questionnaire (QOLRAD) 8 weeks	174 Scores on a Scale Interval 157.0 to 175.0	155 Scores on a Scale Interval 148.0 to 170.0
Quality of Life Questionnaire (QOLRAD) 16 weeks	173 Scores on a Scale Interval 158.0 to 174.0	160 Scores on a Scale Interval 146.0 to 172.0

Adverse Events

Lansoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Sugar Pill)

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

Manager, Clinical Trials

Vanderbilt University Medical Center

Phone: 615-322-4643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place