Asthma PatientsPhase 2SweapeaNCT01197794

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

A Phase 2 study testing AZD1981 in people with Asthma Patients, run by AstraZeneca at 105 sites in 10 countries.

Completed

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

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma Patients
What is being tested?: AZD1981
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,144 participants
Where: 105 sitesin 10 countries
Study dates: Oct 2010to Feb 2012
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

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

Who cannot join

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

Trial locations and contacts

105 sites in 10 countries.

Country

City, postcode or hospital

105 sites in 10 countries

Japan26 sites

Research Site
Asahikawa, Hokkaido
Research Site
Beppu, Oita Prefecture
Research Site
Chitose, Hokkaido
Research Site
Chūō, Tokyo
Research Site
Chuo-ku, Tokyo
Research Site
Fujisawa-shi, Kanagawa
Research Site
Himeji, Hyōgo
Research Site
Hiroshima, Hiroshima
Research Site
Kitahiroshima, Hokkaido
Research Site
Kochi, Kochi
Research Site
Kodaira, Tokyo
Research Site
Kurashiki-shi, Okayama-ken
Research Site
Kyoto, Kyoto
Research Site
Matsue, Shimane
Research Site
Nagaoka, Niigata
Research Site
Naka-gun, Ibaraki
Research Site
Nakano-ku, Tokyo
Research Site
Obihiro, Hokkaido
Research Site
Ohota-ku, Tokyo
Research Site
Ōita, Oita Prefecture
Research Site
Sakaidechō, Kagawa-ken
Research Site
Sapporo, Hokkaido
Research Site
tabashi City, Tokyo
Research Site
Tomakomai, Hokkaido
Research Site
Yanagawa, Fukuoka
Research Site
Yokohama, Kanagawa

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United States19 sites

Research Site
Bellevue, Nebraska
Research Site
Charleston, South Carolina
Research Site
Clinton, South Carolina
Research Site
Collegeville, Pennsylvania
Research Site
Fullerton, California
Research Site
Los Angeles, California
Research Site
Medford, Oregon
Research Site
Mission Viejo, California
Research Site
North Dartmouth, Massachusetts
Research Site
Oklahoma City, Oklahoma
Research Site
Pittsburgh, Pennsylvania
Research Site
Portland, Oregon
Research Site
Rolling Hills Estates, California
Research Site
San Diego, California
Research Site
San Jose, California
Research Site
Sylvania, Ohio
Research Site
Tacoma, Washington
Research Site
Waco, Texas
Research Site
Wheaton, Maryland

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Slovakia15 sites

Research Site
Banská Bystrica
Research Site
Bardejov
Research Site
Bratislava
Research Site
Dunajská Streda
Research Site
Hnúšťa
Research Site
Komárno
Research Site
Košice
Research Site
Levice
Research Site
Liptovský Hrádok
Research Site
Liptovský Mikuláš
Research Site
Prešov
Research Site
Rimavská Sobota
Research Site
Ružomberok
Research Site
Trenčín
Research Site
Zvolen

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Brazil8 sites

Research Site
Belo Horizonte, Minas Gerais
Research Site
Florian Polis, Santa Catarina
Research Site
Juiz de Fora, Minas Gerais
Research Site
Porto Alegre, Brasil
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Santo André, São Paulo
Research Site
São Paulo, São Paulo
Research Site
Vitória, Espírito Santo

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South Africa8 sites

Research Site
Cape Town, South Africa
Research Site
Durban, KwaZulu-Natal
Research Site
Durban, South Africa
Research Site
Durbanville
Research Site
eManzimtoti
Research Site
eMkhomazi, South Africa
Research Site
Lyttleton, Centurion
Research Site
Pretoria

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Ukraine8 sites

Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Odesa
Research Site
Poltava
Research Site
Vinytsa
Research Site
Zaporizhzhya

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Romania6 sites

Research Site
Brasov
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Constanța, Constanța County
Research Site
Iași
Research Site
Tg. Mures

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Argentina5 sites

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

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Mexico5 sites

Research Site
Guadalajara
Research Site
México, D.f.
Research Site
Monterrey, Nuevo León
Research Site
Morelia, Michoacán
Research Site
Tijuana, Estado de Baja California

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Russia5 sites

Research Site
Moscow, Russia
Research Site
Novosibirsk
Research Site
Saint Petersburg
Research Site
Vladikavkaz
Research Site
Yekaterinburg, Russia

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About this study

Official title: 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

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

Conditions: Asthma Patients
Being tested: AZD1981, Placebo
Keywords: Efficacy, safety, tolerability, dose finding, asthma patients

What participants receive

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

AZD1981Drug
AZD1981 twice daily
AZD1981Drug
AZD1981 once daily
PlaceboDrug
Placebo to match AZD1981

Study groups in NCT01197794
Study group	Role	What they receive
AZD1981 10 mg	Experimental	AZD1981 10 mg Receives: Drug: AZD1981
AZD1981 40 mg	Experimental	AZD1981 40 mg Receives: Drug: AZD1981
AZD1981 100 mg	Experimental	AZD1981 100 mg Receives: Drug: AZD1981
AZD1981 400 mg	Experimental	AZD1981 400 mg Receives: Drug: AZD1981
AZD1981 80 mg	Experimental	AZD1981 80 mg Receives: Drug: AZD1981
AZD1981 200 mg	Experimental	AZD1981 200 mg Receives: Drug: AZD1981
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Pre-bronchodilator FEV1 at the Clinic
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Measured: Twelve week treatment period

Secondary outcomes (9)

Morning and Evening PEF
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Measured: Twelve week treatment period
Asthma Control Questionnaire 5-item (ACQ5)
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Measured: Twelve week treatment period
Adverse Events
Number of participants who had at least one adverse event during the randomized treatment period
Measured: Twelve week treatment period
Number of Participants With at Least One Severe Asthma Exacerbation
Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days
Measured: Twelve week treatment period
Number of Participants With at Least One Treatment Failure
Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.
Measured: Twelve week treatment period
Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.
Measured: Twelve week treatment period
Asthma Quality of Life Questionnaire (AQLQ(S))
The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Measured: Twelve week treatment period
Asthma Symptom Score
Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.
Measured: Twelve week treatment period
Total Reliever Medication Use
Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.
Measured: Twelve week treatment period

Timeline

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

Oct 2010Feb 2012

First posted9 Sep 2010 (estimated)
Study startOct 2010
Primary completionFeb 2012
Study completionFeb 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Asthma PatientsStudies 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: 1,144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01197794
Sponsor's protocol ID: D9830C00008
Other IDs: 2010-020407-73
Acronym: Sweapea
Status last verified: Oct 2013
First submitted: 8 Sep 2010
Last updated: 6 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bateman ED, O'Brien C, Rugman P, Luke S, Ivanov S, Uddin M. Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting beta2-agonists in patients with atopic asthma. Drug Des Devel Ther. 2018 May 4;12:1093-1106. doi: 10.2147/DDDT.S147389. eCollection 2018.
PubMed 29765200

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

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All Asthma Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01197794
Acronym / sponsor ID: Sweapea / D9830C00008
Conditions: Asthma Patients
Keywords: Efficacy, safety, tolerability, dose finding, asthma patients
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,144 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 9 Sep 2010 (estimated)
Results: Posted 10 Sep 2013

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
AZD1981 10 mg	Experimental	Drug: AZD1981AZD1981 10 mg
AZD1981 40 mg	Experimental	Drug: AZD1981AZD1981 40 mg
AZD1981 100 mg	Experimental	Drug: AZD1981AZD1981 100 mg
AZD1981 400 mg	Experimental	Drug: AZD1981AZD1981 400 mg
AZD1981 80 mg	Experimental	Drug: AZD1981AZD1981 80 mg
AZD1981 200 mg	Experimental	Drug: AZD1981AZD1981 200 mg
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

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
AZD1981AZD1981 twice daily	Drug	AZD1981 10 mg, AZD1981 100 mg, AZD1981 40 mg, AZD1981 400 mg
AZD1981AZD1981 once daily	Drug	AZD1981 200 mg, AZD1981 80 mg
PlaceboPlacebo to match AZD1981	Drug	Placebo

Primary outcome

Pre-bronchodilator FEV1 at the Clinic
Time frame: Twelve week treatment period
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.

9 secondary outcomes

Morning and Evening PEF
Time frame: Twelve week treatment period
Asthma Control Questionnaire 5-item (ACQ5)
Time frame: Twelve week treatment period
Adverse Events
Time frame: Twelve week treatment period
Number of Participants With at Least One Severe Asthma Exacerbation
Time frame: Twelve week treatment period
Number of Participants With at Least One Treatment Failure
Time frame: Twelve week treatment period
Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
Time frame: Twelve week treatment period
Asthma Quality of Life Questionnaire (AQLQ(S))
Time frame: Twelve week treatment period
Asthma Symptom Score
Time frame: Twelve week treatment period
Total Reliever Medication Use
Time frame: Twelve week treatment period

Results and safety

Results posted to the registry on 10 Sep 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 400 mg	164	148
AZD1981 200 mg	161	146
AZD1981 100 mg	166	153
AZD1981 80 mg	164	152
AZD1981 40 mg	163	149
AZD1981 10 mg	163	144
Placebo	163	142

Primary outcome: Pre-bronchodilator FEV1 at the Clinic

Time frame: Twelve week treatment period. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	Arm 1 - AZD1981 400 mg n = 160	Arm 2 - AZD1981 200 mg n = 156	Arm 3 - AZD1981 100 mg n = 162	Arm 4 - AZD1981 80 mg n = 159	Arm 5 - AZD1981 40 mg n = 158	Arm 6 - AZD1981 10 mg n = 157	Arm7-Placebo n = 154
Value	0.16 (0.10 to 0.21)	0.19 (0.14 to 0.25)	0.19 (0.13 to 0.24)	0.15 (0.10 to 0.21)	0.20 (0.15 to 0.26)	0.15 (0.10 to 0.21)	0.14 (0.08 to 0.19)

Population analysed: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1981 400 mg	0 of 164 (0%)	12 of 164 (7.3%)	Not reported
AZD1981 200 mg	1 of 159 (0.6%)	23 of 159 (14.5%)	Not reported
AZD1981 100 mg	3 of 164 (1.8%)	22 of 164 (13.4%)	Not reported
AZD1981 80 mg	1 of 164 (0.6%)	21 of 164 (12.8%)	Not reported
AZD1981 40 mg	0 of 163 (0%)	20 of 163 (12.3%)	Not reported
AZD1981 10 mg	0 of 163 (0%)	32 of 163 (19.6%)	Not reported
Placebo	1 of 163 (0.6%)	21 of 163 (12.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29765200Bateman ED, O'Brien C, Rugman P, Luke S, Ivanov S, Uddin M. Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting beta2-agonists in patients with atopic asthma. Drug Des Devel Ther. 2018 May 4;12:1093-1106. doi: 10.2147/DDDT.S147389. eCollection 2018.

Related trials for Asthma Patients

RecruitingObservational study
A Multicentre, Single Arm, Non-interventional, Real-world Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China
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RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
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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.

Chris O'Brien, MD study director

AstraZeneca

105 sites in 10 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 Patients, run by AstraZeneca at 105 sites in 10 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 5 inclusion and 5 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in Japan, United States, Slovakia, Brazil, South Africa and 5 more countries. 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 10 Sep 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?

Pre-bronchodilator FEV1 at the Clinic (time frame: Twelve week treatment period). 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 NCT01197794, which also lists 1 linked publication.

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 6 Nov 2013.