Trial · NCT00442013

Lansoprazole to Treat Children With Asthma

NCT00442013, Phase 4, Completed, Johns Hopkins University; results first posted 2012-12-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lansoprazole to Treat Children With Asthma. Trials, record NCT00442013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00442013

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lansoprazole to Treat Children With Asthma
NCT number: NCT00442013
Status: Completed
Phases: Phase 4
Enrollment: 306 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Asthma
Interventions: Lansoprazole, Matching placebo
First posted: 2007-03-01
Last updated: 2012-12-06
Results first posted: 2012-12-06
Limitations and caveats: Results limited to patients without overt Gastroesophageal reflux disease(GERD). Did not conduct on-treatment potential hydrogen(pH) probe studies to confirm treatment effect. Protein-pump inhibitors(PPI) dose may not induce maximal acid suppression.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Juniper Asthma Control Score (ACS)	Measured at Weeks 0, 4, 8, 12, 24	Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points
Secondary	Asthma-specific Quality of Life	Measured at Weeks 0, 4, 8, 12, 16, 20, 24	Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points
Secondary	Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Measured at Weeks 0, 4, 8, 12, 16, 20, 24	A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points
Secondary	Rate of Episodes of Poor Asthma Control (EPAC)	Measured daily for 24 weeks by diary	Episodes of poor asthma control are defined as any one of the following: * 2 consecutive days with peak flow at less than 70% of baseline * prescription of oral corticosteroids for asthma * seeking urgent medical care for asthma symptoms EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks
Secondary	Asthma Symptom Utility Index (ASUI)	Measured at Weeks 0, 4, 8, 12, 16, 20, 24	ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points
Secondary	Airways Reactivity (Assessed by Methacholine PC20)	Measured at Weeks 0 and 24	Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Juniper Asthma Control Score (ACS)	Measured at Weeks 0, 4, 8, 12, 24		score	MEAN
SECONDARY	Asthma-specific Quality of Life	Measured at Weeks 0, 4, 8, 12, 16, 20, 24		score	MEAN
SECONDARY	Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Measured at Weeks 0, 4, 8, 12, 16, 20, 24		Liters	MEAN
SECONDARY	Rate of Episodes of Poor Asthma Control (EPAC)	Measured daily for 24 weeks by diary	The number of episodes of poor asthma control that occurred in each group over the 24-week follow-up period. Some participants experienced more than one EPAC over the course of follow-up	number of episodes of poor asthma contrl	NUMBER
SECONDARY	Asthma Symptom Utility Index (ASUI)	Measured at Weeks 0, 4, 8, 12, 16, 20, 24		score	MEAN
SECONDARY	Airways Reactivity (Assessed by Methacholine PC20)	Measured at Weeks 0 and 24		mg/mL	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Juniper Asthma Control Score (ACS)	Lansoprazole Group	1.1	95% Confidence Interval 0.9 to 1.2	score
Change in Juniper Asthma Control Score (ACS)	Placebo Group	1.0	95% Confidence Interval 0.9 to 1.1	score
Asthma-specific Quality of Life	Lansoprazole Group	5.8	95% Confidence Interval 5.7 to 6.0	score
Asthma-specific Quality of Life	Placebo Group	6.0	95% Confidence Interval 5.9 to 6.2	score
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Lansoprazole Group	2.2	95% Confidence Interval 2.1 to 2.4	Liters
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Placebo Group	2.3	95% Confidence Interval 2.1 to 2.4	Liters
Rate of Episodes of Poor Asthma Control (EPAC)	Lansoprazole Group	230		number of episodes of poor asthma contrl
Rate of Episodes of Poor Asthma Control (EPAC)	Placebo Group	184		number of episodes of poor asthma contrl
Asthma Symptom Utility Index (ASUI)	Lansoprazole Group	0.86	95% Confidence Interval 0.83 to 0.88	score
Asthma Symptom Utility Index (ASUI)	Placebo Group	0.88	95% Confidence Interval 0.86 to 0.90	score

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lansoprazole Group	157
Overall Study	STARTED	Placebo Group	149
Overall Study	COMPLETED	Lansoprazole Group	131
Overall Study	COMPLETED	Placebo Group	132
Overall Study	NOT COMPLETED	Lansoprazole Group	26
Overall Study	NOT COMPLETED	Placebo Group	17

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	upper respiratory infection	Infections and infestations	Lansoprazole Group	93	147
other	upper respiratory infection	Infections and infestations	Placebo Group	74	150
other	Sore throat	Respiratory, thoracic and mediastinal disorders	Lansoprazole Group	77	147
other	Sore throat	Respiratory, thoracic and mediastinal disorders	Placebo Group	59	150
other	Group A streptococcus	Infections and infestations	Lansoprazole Group	6	147
other	Group A streptococcus	Infections and infestations	Placebo Group	11	150
other	Bronchitis	Respiratory, thoracic and mediastinal disorders	Lansoprazole Group	10	147
other	Bronchitis	Respiratory, thoracic and mediastinal disorders	Placebo Group	3	150
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Lansoprazole Group	4	147
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Placebo Group	5	150

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lansoprazole Group
Total, all-cause mortality	Placebo Group
Total, other adverse events	Lansoprazole Group	93	147
Total, other adverse events	Placebo Group	78	150
Total, serious adverse events	Lansoprazole Group	11	149
Total, serious adverse events	Placebo Group	9	157

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22274684	RESULT	PubMed
23197288	DERIVED	PubMed
23600541	DERIVED	PubMed
23623526	DERIVED	PubMed
23932458	DERIVED	PubMed
25213052	DERIVED	PubMed
25844821	DERIVED	PubMed
37536444	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL080450	Study of Acid Reflux Therapy for Children with Asthma	HOLBROOK, JANET T.	JOHNS HOPKINS UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2006 to 2010

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lansoprazole Group vs Placebo Group: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00442013

GET https://conductscience.org/api/trials/v1/NCT00442013/events?page=2

API reference For AI assistants