One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids - Full Text View

One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids (OLIVE)

This study has been completed.

First Received: September 23, 2008 Last Updated: August 12, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00758589

Purpose

The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.

Condition	Intervention	Phase
Asthma	Drug: AZD1981 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Double-blind, Randomised, Parallel Group, Multicentre Phase IIb, Placebo-Controlled, 1 Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Peak expiratory flow [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Asthma symptom score [ Time Frame: Daily ] [ Designated as safety issue: No ]
Use of reliever medication [ Time Frame: Daily ] [ Designated as safety issue: No ]
FEV1 [ Time Frame: At clinic visits ] [ Designated as safety issue: No ]

Enrollment:	510
Study Start Date:	September 2008
Study Completion Date:	July 2009

Arms	Assigned Interventions
1: Experimental	Drug: AZD1981 Oral tablet, 50 mg twice daily
2: Placebo Comparator	Drug: Placebo
3: Experimental	Drug: AZD1981 Oral tablet, 400 mg twice daily
4: Experimental	Drug: AZD1981 Oral tablet, 1000 mg twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Six months history of asthma
Daily use of inhaled glucocorticosteroids
FEV1 40-85% of predicted normal
Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion Criteria:

Other clinically relevant disease or disorders
History of smoking of more than 10 pack years
Respiratory infection within 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758589

Locations

Argentina
Research Site
BUENOS AIRES, Argentina
Research Site
SANTA FE, Argentina
Argentina, Buenos Aires
Research Site
QUILMES, Buenos Aires, Argentina
Argentina, TUCUMAN
Research Site
SAN MIGUEL DE TUCUMAN, TUCUMAN, Argentina
Brazil, BRASIL
Research Site
PORTO ALEGRE, BRASIL, Brazil
Brazil, RJ
Research Site
RIO DE JANEIRO, RJ, Brazil
Brazil, SP
Research Site
SANTO ANDRE, SP, Brazil
Research Site
SAO PAULO, SP, Brazil
Costa Rica, SAN JOSE
Research Site
BARRIO LOS YOSES, SAN JOSE, Costa Rica
Research Site
SAN FRANCISCO DE DOS RIOS, SAN JOSE, Costa Rica
Poland
Research Site
WROCLAW, Poland
Research Site
BYDGOSZCZ, Poland
Research Site
GDALSK, Poland
Research Site
KIELCE, Poland
Research Site
KRAKOW, Poland
Research Site
LUBLIN, Poland
Research Site
POZNAL, Poland
Research Site
SZCZECIN, Poland
Research Site
TARNOW, Poland
Research Site
TUREK, Poland
Research Site
BIALYSTOK, Poland

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Piotr Kuna

University of Lodz, Lodz, Poland

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Christer Hultquist, MD, Medical Science Director, R&D )
Study ID Numbers:	D9830C00004
Study First Received:	September 23, 2008
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00758589 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Poland: Ministry of Health; Costa Rica: Ethics Committee

Keywords provided by AstraZeneca:

Asthma

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009