NCT00628953

Brief Summary

The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Oct 2002

Typical duration for phase_2 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

Enrollment Period

1.5 years

First QC Date

February 26, 2008

Last Update Submit

March 12, 2009

Conditions

Asthma

Keywords

AsthmaAcid RefluxNexiumEsomeprazole

Outcome Measures

Primary Outcomes (1)

  • Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores

    4 weekly

Secondary Outcomes (1)

  • Safety as assessed by adverse event recording and clinical and laboratory measurements.

    4 weekly

Study Arms (2)

1

EXPERIMENTAL
Drug: Esomeprazole

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

EsomeprazoleDRUG

40mg twice a day

Also known as: Nexium
1
PlaceboDRUG

40mg twice a day

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of asthma
  • Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol
  • Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months.
  • Severe heartburn 3 days/week during the run-in period.

You may not qualify if:

  • Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1.
  • Any other significant disease or pathology judged to be clinically significant by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaGastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paula Fernstrom

    Nexium Global Product Director, AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 5, 2008

Study Start

October 1, 2002

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

March 13, 2009

Record last verified: 2009-03