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

Asthma Clinical Trial

— RELAX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317044
• Other study ID #: D9618C00001
• Secondary ID: RELAX
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2006
• Last updated: May 9, 2014
• Start date: April 2006
• Est. completion date: July 2008

Study information

• Verified date: May 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 961
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• GERD

Intervention

Drug:
• Esomeprazole
Esomeprazole 40 mg twice daily
• Esomeprazole
Esomeprazole 40 mg once daily
• Placebo
Placebo twice daily

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad Autónoma de Buenos Aires
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Córdoba
Argentina	Research Site	Córdoba	Córdoba, Argentina
Argentina	Research Site	Monte Grande	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe, Argentina
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	San Miguel De Tucumán	Tucumán, Argentina
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Canada	Research Site	Bay Roberts	Newfoundland and Labrador
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Holyrood	Newfoundland and Labrador
Canada	Research Site	La Malbaie	Quebec
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Woodstock	Ontario
Czech Republic	Research Site	Benesov U Prahy
Czech Republic	Research Site	Beroun
Czech Republic	Research Site	Cvikov
Czech Republic	Research Site	Kladno
Czech Republic	Research Site	Kolin 4
Czech Republic	Research Site	Liberec
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 4
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Rokycany
Czech Republic	Research Site	Tabor
France	Research Site	Brest
France	Research Site	Ferolles Attilly
France	Research Site	Grasse
France	Research Site	Grenoble
France	Research Site	Marseille Cedex 06
France	Research Site	Montpellier
France	Research Site	Paris Cedex
France	Research Site	St Laurent Du Var
France	Research Site	Villejuif
Germany	Research Site	Bad Wörishofen
Germany	Research Site	Berlin
Germany	Research Site	Frankfurt
Germany	Research Site	Freising
Germany	Research Site	Gelnhausen
Germany	Research Site	Gelsenkirchen
Germany	Research Site	Hamburg
Germany	Research Site	Landsberg
Germany	Research Site	Marburg
Germany	Research Site	Nürnberg
Germany	Research Site	Potsdam
Germany	Research Site	Rodgau-dudenhofen
Germany	Research Site	Wolmirstedt
Hungary	Research Site	Budapest
Hungary	Research Site	Füzesabony
Hungary	Research Site	Gyöngyös
Hungary	Research Site	Gyor
Hungary	Research Site	Hódmezovásárhely
Hungary	Research Site	Kaposvár
Hungary	Research Site	Mosonmagyaróvár
Hungary	Research Site	Százhalombatta
Hungary	Research Site	Szombathely
Italy	Research Site	Arenzano	GE
Italy	Research Site	Bussolengo	VR
Italy	Research Site	Cagliari	CA
Italy	Research Site	Crema	CR
Italy	Research Site	Firenze	FI
Italy	Research Site	Napoli
Italy	Research Site	Palermo	PA
Italy	Research Site	Pisa	PI
Italy	Research Site	Prato	PO
Italy	Research Site	Roma
Italy	Research Site	Verona	VR
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Mexico
Mexico	Research Site	Morelia	Michoacan
Mexico	Research Site	Villahermosa	Tabasco
Mexico	Research Site	Zapopan	Jalisco
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdynia
Poland	Research Site	Ilawa
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Piekary Slaskie
Poland	Research Site	Skarzysko-Kamienna
Poland	Research Site	Strzelce Opolskie
Poland	Research Site	Tarnów
Poland	Research Site	Zabrze
Portugal	Research Site	Amadora
Portugal	Research Site	Covilhã
Portugal	Research Site	Porto
Portugal	Research Site	Vila Nova de Gaia
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Nove Zamky
Slovakia	Research Site	Nové Zámky
Slovakia	Research Site	Povazska Bystrica
Slovakia	Research Site	Prievidza
Slovakia	Research Site	Rimavska Sobota
Slovakia	Research Site	Trencín
Switzerland	Research Site	Basel	Basel Stadt
United States	Research Site	Asheville	North Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Charleston	South Carolina
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Fountain Valley	California
United States	Research Site	Greenfield	Wisconsin
United States	Research Site	Houston	Texas
United States	Research Site	Kirkland	Washington
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Mandeville	Louisiana
United States	Research Site	Medford	Oregon
United States	Research Site	Miami	Florida
United States	Research Site	Normal	Illinois
United States	Research Site	Overland Park	Kansas
United States	Research Site	Papillion	Nebraska
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	San Antonio	Texas
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	St. Louis	Missouri
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Sylvania	Ohio
United States	Research Site	Upland	Pennsylvania
United States	Research Site	Wheaton	Maryland
United States	Research Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Mexico,  Poland,  Portugal,  Slovakia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 6 months	No
Secondary	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.	Baseline to 6 months	No
Secondary	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.	Baseline to 6 months	No
Secondary	Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting ß2-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.	Baseline to 6 months	No
Secondary	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.	Baseline to 6 months	No
Secondary	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.	From randomization (Visit 3) to visit 7.	No
Secondary	Number of Patients With Severe Asthma Exacerbations.		Up to 6 months	No
Secondary	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).	From randomization (Visit 3) to Visit 7	No
Secondary	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.	Randomization (Visit 3) to Visit 7	No
Secondary	Number of Severe Adverse Events		Up to 6 months	No
Secondary	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	Baseline to 6 months	No
Secondary	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	Baseline to 6 months	No
Secondary	Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting ß2-agonists (SABAs) - Night	Participants must have both baseline and follow up measure to be included in analysis	Baseline to 6 months	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US
•   CSR-D9618C00001.pdf