Moderate to severe asthma and symptoms of gastroesophageal reflux disease (GERD)
Conditions
Interventions
Product Name: Esomeprazole
Product Code: (Nexium)
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: esomeprazole magnesium trihydrate
CAS Number: 217087-09-7
Current Sponsor cod
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study run-in period the patient must fulfil all of the following criteria at Visit 2: 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, for at least 6 months prior to Visit 2. 4. A reversibility in FEV1 of at least 12% and =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 =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. 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 = 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-hourpH monitoring up to 3 years prior to Visit 2, measured by catheter basedor catheter free (BRAVO®) techniques according to the manufacturer’s instruction. The limit of percentage time of pH=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 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 =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 priorto 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. 10. Patients with a known hypersensitivity to any component of any PPI: esomeprazole,omeprazole, lansoprazole, rabeprazole, pantoprazole, or tenatoprazole. Any of the following is regarded as a criterion for exclusion from the study at Visit 3: 17. A decrease in FEV1 >20% from Visit 2 and/or FEV1 <45% of the predicted normal value. 18. A clinically important asthma exacerbation, as judged by the investigator, during the run-in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the anti-asthmatic effect of esomeprazole, given either as 40 mg twice daily or 40 mg once daily, with that of placebo in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease (GERD) by evaluation of change in morning Peak Expiratory Flow (mPEF) from baseline (mean ofthe last 7 days in the run-in period) to treatment period (mean of all available data during the treatment period) as the primary outcome variable.;Secondary Objective: Investigate the effect on symptoms of GERD when treating adult patients having moderate to severe asthma and symptoms of GERD with esomeprazole 40 mg twice daily or 40 mg once daily or placebo by evaluation of change in symptoms of GERD as measured by Reflux Disease Questionnaire (RDQ) Assess the safety and tolerability of the treatments esomeprazole 40 mg twice daily and 40 mg once daily for 6 months.;Primary end point(s): There is no primary endpoint in this study The primary outcome variable: Change in mPEF from baseline to treatment period. | — |
Countries
Czech Republic, Germany, Hungary, Italy, Portugal
Outcome results
None listed