AsthmaPhase 2OLIVENCT00758589

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

A Phase 2 study testing AZD1981 in people with Asthma, run by AstraZeneca at 21 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: AZD1981
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 368 participants
Where: 21 sitesin 4 countries
Study dates: Sep 2008to Jul 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

21 sites in 4 countries.

Country

City, postcode or hospital

21 sites in 4 countries

Poland11 sites

Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Gdalsk
Research Site
Kielce
Research Site
Krakow
Research Site
Lublin
Research Site
Poznal
Research Site
Szczecin
Research Site
Tarnów
Research Site
Turek
Research Site
Wroclaw

Other trials in Poland

Argentina4 sites

Research Site
Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires
Research Site
San Miguel de Tucumán, Tucumán Province
Research Site
Santa Fe, Santa Fe Province

Other trials in Argentina

Brazil4 sites

Research Site
Porto Alegre, Brasil
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
Santo André, São Paulo
Research Site
São Paulo, São Paulo

Other trials in Brazil

Costa Rica2 sites

Research Site
Barrio Los Yoses, Provincia de San José
Research Site
San Francisco de Dos Ríos, Provincia de San José

Other trials in Costa Rica

About this 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

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

Conditions: Asthma
Being tested: AZD1981, Placebo
Keywords: Asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1981Drug
Oral tablet, 50 mg twice daily
AZD1981Drug
Oral tablet, 400 mg twice daily
AZD1981Drug
Oral tablet, 1000 mg twice daily
PlaceboDrug

Study groups in NCT00758589
Study group	Role	What they receive
AZD1981 50 mg	Experimental	AZD1981 50 mg Twice Daily (Bid) Receives: Drug: AZD1981
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
AZD1981 400 mg	Experimental	AZD1981 400 mg Twice Daily (Bid) Receives: Drug: AZD1981
AZD1981 1000 mg	Experimental	AZD1981 1000 mg Twice Daily (Bid) Receives: Drug: AZD1981

What is being measured

The primary outcome is the main question the study is designed to answer.

Morning Peak Expiratory Flow (mPEF)
Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)
Measured: Week 4

Secondary outcomes (14)

Evening Peak Expiratory Flow (ePEF)
Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)
Measured: Week 4
Morning Forced Expiratory Volume in 1 Second (mFEV1)
Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Measured: Week 4
Evening Forced Expiratory Volume in 1 Second (eFEV1)
Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Measured: Week 4
Total Use of Reliever
Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)
Measured: Week 4
Night-time Asthma Symptom Score
Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).
Measured: Week 4
Day-time Asthma Symptom Score
Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).
Measured: Week 4
Awakenings
Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)
Measured: Week 4
Asthma Control Day
Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.
Measured: Week 4
Symptom Free Day
Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.
Measured: Week 4
Reliever Free Day
Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.
Measured: Week 4
Forced Expiratory Volume in 1 Second (FEV1) at the Clinic
Mean FEV1 during the treatment period (mean value at Week 4)
Measured: Week 4
Forced Vital Capacity (FVC) at the Clinic
Mean FVC during the treatment period (mean value at Week 4)
Measured: Week 4
Asthma Control Questionnaire 5 Items (ACQ5)
Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).
Measured: Week 4
Adverse Event (AE)
Number of patients reporting at least one event
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jul 2009

First posted25 Sep 2008 (estimated)
Study startSep 2008
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 368 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758589
Sponsor's protocol ID: D9830C00004
Acronym: OLIVE
Status last verified: Jan 2014
First submitted: 23 Sep 2008
Last updated: 26 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00758589
Acronym / sponsor ID: OLIVE / D9830C00004
Conditions: Asthma
Keywords: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 368 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2008
Study completion: Jul 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 13 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AZD1981 50 mg	Experimental	Drug: AZD1981AZD1981 50 mg Twice Daily (Bid)
Placebo	Placebo comparator	Drug: PlaceboPlacebo
AZD1981 400 mg	Experimental	Drug: AZD1981AZD1981 400 mg Twice Daily (Bid)
AZD1981 1000 mg	Experimental	Drug: AZD1981AZD1981 1000 mg Twice Daily (Bid)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD1981Oral tablet, 50 mg twice daily	Drug	AZD1981 50 mg
AZD1981Oral tablet, 400 mg twice daily	Drug	AZD1981 400 mg
AZD1981Oral tablet, 1000 mg twice daily	Drug	AZD1981 1000 mg
Placebo	Drug	Placebo

Primary outcome

Morning Peak Expiratory Flow (mPEF)
Time frame: Week 4
Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)

14 secondary outcomes

Evening Peak Expiratory Flow (ePEF)
Time frame: Week 4
Morning Forced Expiratory Volume in 1 Second (mFEV1)
Time frame: Week 4
Evening Forced Expiratory Volume in 1 Second (eFEV1)
Time frame: Week 4
Total Use of Reliever
Time frame: Week 4
Night-time Asthma Symptom Score
Time frame: Week 4
Day-time Asthma Symptom Score
Time frame: Week 4
Awakenings
Time frame: Week 4
Asthma Control Day
Time frame: Week 4
Symptom Free Day
Time frame: Week 4
Reliever Free Day
Time frame: Week 4
Forced Expiratory Volume in 1 Second (FEV1) at the Clinic
Time frame: Week 4
Forced Vital Capacity (FVC) at the Clinic
Time frame: Week 4
Asthma Control Questionnaire 5 Items (ACQ5)
Time frame: Week 4
Adverse Event (AE)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 13 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD1981 50 mg Twice Daily (Bid)	95	92
AZD1981 400 mg Twice Daily (Bid)	90	87
AZD1981 1000 mg Twice Daily (Bid)	92	86
Placebo	91	85

Primary outcome: Morning Peak Expiratory Flow (mPEF)

Time frame: Week 4. Mean (Standard Deviation). Unit: L/min

Measure	AZD1981 50 mg Twice Daily (Bid) n = 95	AZD1981 400 mg Twice Daily (Bid) n = 89	AZD1981 1000 mg Twice Daily (Bid) n = 92	Placebo n = 90
Value	346.42 (132.70)	362.54 (134.69)	352.87 (124.22)	329.75 (140.14)

Population analysed: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1981 50 mg Twice Daily (Bid)	0 of 95 (0%)	5 of 95 (5.3%)	Not reported
AZD1981 400 mg Twice Daily (Bid)	0 of 90 (0%)	6 of 90 (6.7%)	Not reported
AZD1981 1000 mg Twice Daily (Bid)	1 of 92 (1.1%)	11 of 92 (12%)	Not reported
Placebo	1 of 91 (1.1%)	7 of 91 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Piotr Kuna principal investigator

University of Lodz, Lodz, Poland

21 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1981 in people with Asthma, run by AstraZeneca at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Poland, Argentina, Brazil, Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morning Peak Expiratory Flow (mPEF) (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00758589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.