A 6-month randomized, double-blind, parallel-group, multicentre, placebo-controlled Phase II study to compare anti-asthmatic effect and safety of esomeprazole NexiumTR 40 mg twice daily or 40 mg once daily with placebo in adults with asthma - RELAX STUDY
- Conditions
- Sub-optimally controlled moderate to severe asthma and symptoms of GERD.MedDRA version: 6.1Level: PTClassification code 10003553
- Registration Number
- EUCTR2005-004543-57-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 1015
1. Provision of written informed consent. 2. Female or male aged 18 to 70 years inclusive. 3. Clinical diagnosis of asthma as defined by the ATS definition Expert Panel Report 2 1997 for at least 6 months prior to Visit 2. 4. A reversibility in FEV1 of at least 12 and 8805;0.20 L from baseline after inhalation of 2 x 0.5 mg terbutaline Bricanyl Turbuhaler or 2 x 0.2 mg albuterol via a pressurized metered dose inhaler pMDI . 5. Daily use of inhaled GCS and LABA for 8805;3 months prior to Visit 2. 6. A history of at least one clinically important asthma exacerbation, as judged by the investigator, between 1 to 12 months prior to Visit 2 ie, not within the last 30 days prior to Visit 2 . 7. A history of at least 3 months of 1 or more of the 3 GERD symptoms listed in inclusion criterion no 8. 8. Symptoms or history of GERD. According to scores in patient s self-reported RDQ at least 1 of the following GERD symptoms must have a frequency of 8805; 2 days during the last week and at least 1 symptom must be of at least moderate severity -a burning feeling behind the breastbone -pain behind the breastbone -an acid taste in the mouth or -patient must have a documented history of an abnormal esophageal 24-hour pH monitoring up to 3 years prior to Visit 2, measured by catheter based or catheter free BRAVO techniques according to the manufacturer s instruction. The limit of percentage esophageal acid exposure, should be the same as the local references for respective technique.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients with clinically relevant abnormalities at Visit 2 ECG, vital signs, physical examination, or laboratory values , as judged by the investigator. 2. Any significant disease or disorder eg, cardiovascular, pulmonary other than asthma , gastrointestinal other than GERD , liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or patient s ability to participate in the study. 3. Patients with alarm symptoms such as unintentional weight loss, haematemesis, jaundice, dysphagia, or any other sign indicating serious or malignant disease. 4. Patients with a smoking history of 8805;10 pack-year ie, equivalent of smoking 20 cigarettes per day for 10 years . 5. Use of oral, rectal, or parenteral GCS within 30 days prior to Visit 2. 6. Patients 50 years of age with GERD symptoms according to inclusion criterion no 8 who have not been investigated x-ray of upper gastrointestinal tract or endoscopy within 1 year prior to Visit 2 to exclude upper gastrointestinal tract malignant disease. 7. Patients who have had previous surgery on the esophagus or the stomach. 8. Patients with endoscopy-verified erosive esophagitis within the last 16 weeks prior to Visit 2 or Barrett s esophagus with associated dysplasia. 9. Pregnancy or breast-feeding. Fertile women without acceptable contraceptive measures, as judged by the investigator. Fertile women are defined as women of child-bearing potential from first menstruation to 1 year after last menstruation. Acceptable methods of birth control include contraceptive patch, intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive started at least 1 month prior to Visit 2 and continuing for the duration of the study , or condoms with spermicide, tubal ligation, and double-barrier methods. Single-barrier methods alone and rhythm methods are not acceptable methods of birth control. 10. Patients with a known hypersensitivity to any component of any PPI esomeprazole,omeprazole,lansoprazole, rabeprazole, pantoprazole, or tenatoprazole. 11. Planned donation of blood during the study. 12. Planned hospitalisation during the study. 13. Suspected poor capability, as judged by the investigator, of following instructions of the study, eg, because of alcohol or drug abuse, or any other reason. 14. Participation in another clinical study of any investigational drug within 30 days prior to Visit 2 or during the study. 15. Previous randomization in the present study. 16. Involvement in the planning and conduct of the study applies to both AstraZeneca staff and staff at the study site .
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method