NCT00758589

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Sep 2008

Geographic Reach
4 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

December 13, 2013

Completed
Last Updated

February 26, 2014

Status Verified

January 1, 2014

First QC Date

September 23, 2008

Results QC Date

July 1, 2013

Last Update Submit

January 24, 2014

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • Morning Peak Expiratory Flow (mPEF)

    Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)

    Week 4

Secondary Outcomes (14)

  • Evening Peak Expiratory Flow (ePEF)

    Week 4

  • Morning Forced Expiratory Volume in 1 Second (mFEV1)

    Week 4

  • Evening Forced Expiratory Volume in 1 Second (eFEV1)

    Week 4

  • Total Use of Reliever

    Week 4

  • Night-time Asthma Symptom Score

    Week 4

  • +9 more secondary outcomes

Study Arms (4)

AZD1981 50 mg

EXPERIMENTAL

AZD1981 50 mg Twice Daily (Bid)

Drug: AZD1981

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

AZD1981 400 mg

EXPERIMENTAL

AZD1981 400 mg Twice Daily (Bid)

Drug: AZD1981

AZD1981 1000 mg

EXPERIMENTAL

AZD1981 1000 mg Twice Daily (Bid)

Drug: AZD1981

Interventions

AZD1981DRUG

Oral tablet, 50 mg twice daily

AZD1981 50 mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Buenos Aires, Argentina, Argentina

Location

Research Site

Quilmes, Buenos Aires, Argentina

Location

Research Site

Santa Fe, Santa Fe Province, Argentina

Location

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Research Site

Porto Alegre, Brasil, Brazil

Location

Research Site

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Research Site

Santo André, São Paulo, Brazil

Location

Research Site

São Paulo, São Paulo, Brazil

Location

Research Site

Barrio Los Yoses, Provincia de San José, Costa Rica

Location

Research Site

San Francisco de Dos Ríos, Provincia de San José, Costa Rica

Location

Research Site

Bialystok, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Gdalsk, Poland

Location

Research Site

Kielce, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Lublin, Poland

Location

Research Site

Poznal, Poland

Location

Research Site

Szczecin, Poland

Location

Research Site

Tarnów, Poland

Location

Research Site

Turek, Poland

Location

Research Site

Wroclaw, Poland

Location

MeSH Terms

Conditions

Asthma

Interventions

AZD1981

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Alison Holt
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Piotr Kuna

    University of Lodz, Lodz, Poland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

September 1, 2008

Study Completion

July 1, 2009

Last Updated

February 26, 2014

Results First Posted

December 13, 2013

Record last verified: 2014-01

Locations

AR(4)BR(4)CO(2)PL(11)