AsthmaPhase 2RELAXNCT00317044

Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma

A Phase 2 study testing Esomeprazole in people with Asthma and GERD, run by AstraZeneca at 130 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Asthma, GERD
What is being tested?: Esomeprazole
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 961 participants
Where: 130 sitesin 14 countries
Study dates: Apr 2006to Jul 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults with diagnosis of asthma since at least 6 months.
Symptoms of asthma during run-in.
At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Who cannot join

Patients with clinically relevant abnormalities.
Patients with a smoking history of ≥10 pack-year.
Patients who have had previous surgery on the esophagus or the stomach.

Trial locations and contacts

130 sites in 14 countries.

Country

City, postcode or hospital

130 sites in 14 countries

United States27 sites

Research Site
Asheville, North Carolina
Research Site
Atlanta, Georgia
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Austin, Texas
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Birmingham, Alabama
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Charleston, South Carolina
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Cincinnati, Ohio
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Fountain Valley, California
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Greenfield, Wisconsin
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Houston, Texas
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Kirkland, Washington
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Little Rock, Arkansas
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Mandeville, Louisiana
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Medford, Oregon
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Miami, Florida
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Normal, Illinois
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Overland Park, Kansas
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Papillion, Nebraska
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Pittsburgh, Pennsylvania
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San Antonio, Texas
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Scottsdale, Arizona
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Seattle, Washington
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St Louis, Missouri
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Stockbridge, Georgia
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Sylvania, Ohio
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Upland, Pennsylvania
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Wheaton, Maryland
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Wichita, Kansas

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Germany13 sites

Research Site
Bad Wörishofen
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Berlin
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Frankfurt
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Freising
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Gelnhausen
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Gelsenkirchen
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Hamburg
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Landsberg
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Marburg
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Nuremberg
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Potsdam
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Rodgau-dudenhofen
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Wolmirstedt

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Canada11 sites

Research Site
Bay Roberts, Newfoundland and Labrador
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Brampton, Ontario
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Calgary, Alberta
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Hamilton, Ontario
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Holyrood, Newfoundland and Labrador
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La Malbaie, Quebec
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Mississauga, Ontario
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Montreal, Quebec
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Québec, Quebec
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Toronto, Ontario
Research Site
Woodstock, Ontario

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Italy11 sites

Research Site
Arenzano, GE
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Bussolengo, VR
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Cagliari, CA
Research Site
Crema, CR
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Florence, FI
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Naples
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Palermo, PA
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Pisa, PI
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Prato, PO
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Roma, Roma
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Verona, VR

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Poland10 sites

Research Site
Bydgoszcz
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Gdynia
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Iława
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Krakow
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Lodz
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Piekary Śląskie
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Skarżysko-Kamienna
Research Site
Strzelce Opolskie
Research Site
Tarnów
Research Site
Zabrze

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Argentina9 sites

Research Site
Buenos Aires
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province
Research Site
Córdoba, Córdoba, Argentina
Research Site
Monte Grande, Buenos Aires
Research Site
Quilmes, Buenos Aires
Research Site
Rosario, Santa Fe Province
Research Site
Rosario, Santa Fe, Argentina
Research Site
San Miguel de Tucumán, Tucumán, Argentina

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Czechia9 sites

Research Site
Benesov U Prahy
Research Site
Beroun
Research Site
Cvikov
Research Site
Kladno
Research Site
Kolín
Research Site
Liberec
Research Site
Prague
Research Site
Rokycany
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Tábor

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France9 sites

Research Site
Brest
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Férolles-Attilly
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Grasse
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Grenoble
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Marseille
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Montpellier
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Paris
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Saint-Laurent-du-Var
Research Site
Villejuif

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Hungary9 sites

Research Site
Budapest
Research Site
Füzesabony
Research Site
Gyöngyös
Research Site
Győr
Research Site
Hódmezővásárhely
Research Site
Kaposvár
Research Site
Mosonmagyaróvár
Research Site
Százhalombatta
Research Site
Szombathely

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Slovakia7 sites

Research Site
Bratislava
Research Site
Košice
Research Site
Nové Zámky
Research Site
Považská Bystrica
Research Site
Prievidza
Research Site
Rimavská Sobota
Research Site
Trenčín

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Bulgaria5 sites

Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Varna

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Mexico5 sites

Research Site
Guadalajara, Jalisco
Research Site
México
Research Site
Morelia, Michoacán
Research Site
Villahermosa, Tabasco
Research Site
Zapopan, Jalisco

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Portugal4 sites

Research Site
Amadora
Research Site
Covilha
Research Site
Porto
Research Site
Vila Nova de Gaia

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Switzerland1 site

Research Site
Basel, Canton of Basel-City

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About this study

Official title: A 6-month Randomized, Double-blind, Parallel-group, Multicentre, Placebo-controlled Phase II Study to Compare Anti-asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma

Conditions: Asthma, GERD
Being tested: Esomeprazole, Placebo
Keywords: Moderate to severe Asthma, Gastroesophageal Reflux Disease, esomeprazole, GERD
Medical subject headings: Asthma, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsomeprazoleDrug
Esomeprazole 40 mg twice daily
EsomeprazoleDrug
Esomeprazole 40 mg once daily
PlaceboDrug
Placebo twice daily

Study groups in NCT00317044
Study group	Role	What they receive
Esomeprazole 40 mg twice daily	Experimental	Not described Receives: Drug: Esomeprazole
Esomeprazole 40 mg once daily	Experimental	Not described Receives: Drug: Esomeprazole
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.
Measured: Baseline to 6 months

Secondary outcomes (12)

Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.
Measured: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.
Measured: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months
This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.
Measured: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.
Measured: Baseline to 6 months
Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.
Measured: From randomization (Visit 3) to visit 7.
Number of Patients With Severe Asthma Exacerbations.
Measured: Up to 6 months
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7
The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).
Measured: From randomization (Visit 3) to Visit 7
Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7
The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.
Measured: Randomization (Visit 3) to Visit 7
Number of Severe Adverse Events
Measured: Up to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night
Participants must have both baseline and follow up measure to be included in analysis
Measured: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day
Participants must have both baseline and follow up measure to be included in analysis
Measured: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night
Participants must have both baseline and follow up measure to be included in analysis
Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Jul 2008

First posted24 Apr 2006 (estimated)
Study startApr 2006
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 961 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00317044
Sponsor's protocol ID: D9618C00001
Other IDs: RELAX
Acronym: RELAX
Status last verified: May 2014
First submitted: 20 Apr 2006
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28.
PubMed 20110554

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-month Randomized, Double-blind, Parallel-group, Multicentre, Placebo-controlled Phase II Study to Compare Anti-asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma
ClinicalTrials.gov ID: NCT00317044
Acronym / sponsor ID: RELAX / D9618C00001
Conditions: Asthma, GERD
Keywords: Moderate to severe Asthma, Gastroesophageal Reflux Disease, esomeprazole, GERD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 961 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 24 Apr 2006 (estimated)
Results: Posted 9 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Esomeprazole 40 mg twice daily	Experimental	Drug: Esomeprazole
Esomeprazole 40 mg once daily	Experimental	Drug: Esomeprazole
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults with diagnosis of asthma since at least 6 months.
Symptoms of asthma during run-in.
At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Key exclusion criteria (3 listed)

Patients with clinically relevant abnormalities.
Patients with a smoking history of ≥10 pack-year.
Patients who have had previous surgery on the esophagus or the stomach.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EsomeprazoleEsomeprazole 40 mg twice daily	Drug	Esomeprazole 40 mg twice daily
EsomeprazoleEsomeprazole 40 mg once daily	Drug	Esomeprazole 40 mg once daily
PlaceboPlacebo twice daily	Drug	Placebo

Primary outcome

Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).
Time frame: Baseline to 6 months
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.

12 secondary outcomes

Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
Time frame: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
Time frame: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months
Time frame: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
Time frame: Baseline to 6 months
Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
Time frame: From randomization (Visit 3) to visit 7.
Number of Patients With Severe Asthma Exacerbations.
Time frame: Up to 6 months
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7
Time frame: From randomization (Visit 3) to Visit 7
Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7
Time frame: Randomization (Visit 3) to Visit 7
Number of Severe Adverse Events
Time frame: Up to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night
Time frame: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day
Time frame: Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night
Time frame: Baseline to 6 months

Results and safety

Results posted to the registry on 9 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esomeprazole 40 mg Twice Daily	320	272
Esomeprazole 40 mg Once Daily	313	273
Placebo	328	283

Primary outcome: Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).

Time frame: Baseline to 6 months. Least squares mean (Standard Error). Unit: L/minute

Measure	Esomeprazole 40 mg Twice Daily n = 316	Esomeprazole 40 mg Once Daily n = 311	Placebo n = 327
Value	21.1891 (2.8689)	19.1847 (2.8422)	15.6771 (2.8086)

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole 40 mg Twice Daily	7 of 319 (2.2%)	37 of 319 (11.6%)	Not reported
Esomeprazole 40 mg Once Daily	5 of 313 (1.6%)	44 of 313 (14.1%)	Not reported
Placebo	5 of 328 (1.5%)	55 of 328 (16.8%)	Not reported

Limitations and caveats (from the sponsor): Numbers of patients analyzed in each of the Outcome Measures varies due to the amount of qualifying data captured for the patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20110554Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28.
CSR-D9618C00001.pdfLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Nexium Medical Science Director, MD study director

AstraZeneca

130 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Esomeprazole in people with Asthma and GERD, run by AstraZeneca at 130 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Germany, Canada, Italy, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period). (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317044, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.