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 - NA
- Conditions
- Moderate to severe asthma and symptoms of gastroesophageal reflux disease (GERD)
- Registration Number
- EUCTR2005-004543-57-HU
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
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<4, assessed as pathological esophageal acid exposure, should be the same as the local references for respective technique.
To be randomized to the treatment period, the following criteria must be fulfilled at Visit 3:
1. Run-in diary data for at least 7 of the last 10 days of the run-in period.
2. Mean mPEF during the last 7 days of the run-in period of 50-85% of postbronchodilatory PEF.
3. Total intake of the supplied rescue medication must not exceed an acid-binding capacity of 100 mmol HCl/day during the run-in period.
4. Total asthma symptom score (night-time plus daytime) of = 1 on at least 4 of the last 7 days of the run-in period.
5. Symptoms of GERD during run-in. According to scores in patient’s self-reported RDQ at least 1 of the symptoms must have a frequency of = 2 of the last 7 days ofthe run-in period 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.
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 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.
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