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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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

AstraZeneca Clinical Trial Information – Outside US

Research Site

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

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.

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.

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

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.

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.

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.

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).

Participants must have both baseline and follow up measure to be included in analysis

Arms	Assigned Interventions
Experimental: Esomeprazole 40 mg twice daily	Drug: Esomeprazole Esomeprazole 40 mg twice daily
Experimental: Esomeprazole 40 mg once daily	Drug: Esomeprazole Esomeprazole 40 mg once daily
Placebo Comparator: Placebo	Drug: Placebo Placebo twice daily

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

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AstraZeneca Clinical Trial Information – Outside US

CSR-D9618C00001.pdf

CSR-D9618C00001.pdf

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