Trial Outcomes & Findings for The Utility of Nexium in Chronic Cough and Reflux Disease (NCT NCT00287339)

Last Updated: 2012-01-10

Results Overview

It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, "I cannot sleep at night" and "I cough and it makes me retch." The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is "strongly disagree," and 4 is "strongly agree." The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

baseline and 12 weeks

Results posted on

2012-01-10

Participant Flow

recruited from hospital clinics - subjects with chronic cough.

. After initial eligibility screening, all consenting participants entered a 7-day run-in period, during which all subjects took a placebo pill twice a day, for the purpose of ensuring compliance with study medication and assessment of cough severity under baseline conditions.

Participant milestones

Participant milestones
Measure	Esomeprazole Arm Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.	Placebo Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
Overall Study STARTED	22	18
Overall Study COMPLETED	22	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Utility of Nexium in Chronic Cough and Reflux Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esomeprazole Arm n=22 Participants Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.	Placebo n=18 Participants Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	17 Participants n=4 Participants	37 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Age Continuous	49.5 years STANDARD_DEVIATION 12 • n=93 Participants	51.0 years STANDARD_DEVIATION 11.6 • n=4 Participants	50 years STANDARD_DEVIATION 11.7 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment United States	22 participants n=93 Participants	18 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Outcome measures
Measure	Esomeprazole Arm n=22 Participants Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.	Placebo n=18 Participants Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
Change in Cough-Specific Quality of Life Questionnaire	9.8 participants Standard Deviation 12.2	5.8 participants Standard Deviation 11.1

Adverse Events

Esomeprazole Arm

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

Dr Nicholas Shaheen

UNC_ChapelHill

Phone: 919 9667047

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place