DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Adults With Moderate to Severe Asthma

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Budesonide (Drug); Budesonide (Drug); Budesonide (Drug); Budesonide (Drug); Budesonide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bertil Andersson, Study Director, Affiliation: AstraZeneca

Summary

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

Clinical Details

Official title: A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.

Secondary outcome:

Percentage of symptom free days

Percentage of symptom free nights

Percentage of symptom free 24-hours

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female aged 12 or over who have asthma

- Ability to properly use an electronic diary

- Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion Criteria:

- Hospitalised at least one once or required emergency treatment due to asthma in the

previous 6 months

- Planned hospitalisation during the study

- pregnant women or women planning to become pregnant

Locations and Contacts

Additional Information

Starting date: April 2003
Last updated: January 21, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017