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Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients

A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients

NCT01197794•AstraZeneca

View on ClinicalTrials.gov

Summary

The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
•6 months history of asthma according to ATS definition
•Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
•Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
•A total ACQ5 score of 1.5 or more

Exclusion Criteria

•Respiratory infection significantly affecting the asthma
•Any significant disease and disorder that may put the patient at risk or influence study results
•Any clinically relevant abnormal findings
•A smoking history of more than 10 pack years
•Intake of oral, rectal or parenteral glucocorticosteroids

Locations (105)

Research Site

Fullerton, California, United States

Research Site

Los Angeles, California, United States

Research Site

Mission Viejo, California, United States

Research Site

Rolling Hills Estates, California, United States

Research Site

San Diego, California, United States

Research Site

San Jose, California, United States

Research Site

Wheaton, Maryland, United States

Research Site

North Dartmouth, Massachusetts, United States

Research Site

Bellevue, Nebraska, United States

Research Site

Sylvania, Ohio, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

November 6, 2013

Enrollment

1,144

ACTUAL participants

Conditions

Asthma Patients

Interventions

AZD1981

DRUG

AZD1981

DRUG

Placebo

DRUG

Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting

NCT06786767

AsthmaAsthma Patients+1 more

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COMPLETEDPHASE4

ICS+LABA Vs. ICS+LABA+Omalizumab: Impact on Asthma Control and Gene Expression

NCT06869382

Asthma Patients

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients

Inclusion Criteria

Exclusion Criteria

Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting

ICS+LABA Vs. ICS+LABA+Omalizumab: Impact on Asthma Control and Gene Expression

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.