AsthmaPhase 2AllergenNCT01225549

The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen

A Phase 2 study testing AZD5423 and Budesonide 200 microgram in people with Asthma, run by AstraZeneca at 4 sites in Canada.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Asthma
What is being tested?: AZD5423 and Budesonide 200 microgram
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 4 sitesCanada
Study dates: Nov 2010to Dec 2011
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

18-60 years of age
Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze
Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response
Positive skin prick test to common aeroallergens

Who cannot join

Any clinically significant disease or disorder
Any clinically relevant abnormal finding at screening examinations
Smoker or ex-smoker who has stopped smoking < 12 months prior to study start
Worsening of asthma or respiratory infection within 6 weeks from visit 1
Allergen-specific immunotherapy within 6 months prior to visit 1

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

Research Site
Calgary, Alberta
Research Site
Hamilton, Ontario
Research Site
Québec, Quebec
Research Site
Saskatoon, Saskatchewan

Other trials in Canada

About this study

Official title: A Double-blind, Double-dummy, Randomised, Placebo-controlled, 4-way, Crossover, Multi-centre Phase II Study With Budesonide as an Active Control to Evaluate the Efficacy and Safety of 2 Doses of Inhaled AZD5423 Over 7 Days in Patients With Mild Allergic Asthma Challenged With an Inhaled Allergen

The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.

Conditions: Asthma
Being tested: AZD5423, Budesonide 200 microgram, Placebo
Keywords: Allergen Challenge, Asthma, Inhaled selective glucocorticoid receptor agonist (iSEGRA)
Medical subject headings: Asthma

What participants receive

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

AZD5423Drug
Suspension for nebulisation once daily 7 days
Budesonide 200 microgramDrug
Also called Pulmicort
Dry powder for inhalation twice daily 7 days
PlaceboDrug
Solution for nebulisation once daily 7 days
PlaceboDrug
Solution for nebulisation once daily 7 days

Study groups in NCT01225549
Study group	Role	What they receive
1	Experimental	AZD5423 75ug Receives: Drug: AZD5423; Drug: Placebo
2	Experimental	AZD5423 300ug Receives: Drug: AZD5423; Drug: Placebo
3	Active comparator	Budesonide 200 microgram Receives: Drug: Budesonide 200 microgram; Drug: Placebo
4	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1
Measured: From Randomization to end of treatment

Secondary outcomes (8)

Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge
Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1
Measured: From Randomization to end of treatment
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1
Measured: From Randomization to end of treatment
Airway Hyperresponsiveness by Assessment of Methacholine PC20
The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)
Measured: Day 1 (pre-dose)
Airway Hyperresponsiveness by Assessment of Methacholine PC20
The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)
Measured: Day 5 ([post-dose] pre allergen challenge)
Airway Hyperresponsiveness by Assessment of Methacholine PC20
The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)
Measured: Day 7 ([post-dose] 24 hours post allergen challenge)
Changes in Sputum Eosinophils Differentials (Percentage)
The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)
Measured: Day 5 (post dose)
Changes in Sputum Eosinophils Differentials (Percentage)
The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)
Measured: Day 6 ([post dose] 7 hours post allergen challenge)
Changes in Sputum Eosinophils Differentials (Percentage)
The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)
Measured: Day 7 ([post dose] 24 hours post allergen challenge)

Timeline

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

Nov 2010Dec 2011

First posted21 Oct 2010 (estimated)
Study startNov 2010
Primary completionDec 2011
Study completionDec 2011

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 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01225549
Sponsor's protocol ID: D2340C00005
Acronym: Allergen
Status last verified: Mar 2015
First submitted: 15 Oct 2010
Last updated: 2 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Gauvreau GM, Boulet LP, Leigh R, Cockcroft DW, Killian KJ, Davis BE, Deschesnes F, Watson RM, Swystun V, Mardh CK, Wessman P, Jorup C, Aurivillius M, O'Byrne PM. A nonsteroidal glucocorticoid receptor agonist inhibits allergen-induced late asthmatic responses. Am J Respir Crit Care Med. 2015 Jan 15;191(2):161-7. doi: 10.1164/rccm.201404-0623OC.
PubMed 25473939

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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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Double-dummy, Randomised, Placebo-controlled, 4-way, Crossover, Multi-centre Phase II Study With Budesonide as an Active Control to Evaluate the Efficacy and Safety of 2 Doses of Inhaled AZD5423 Over 7 Days in Patients With Mild Allergic Asthma Challenged With an Inhaled Allergen
ClinicalTrials.gov ID: NCT01225549
Acronym / sponsor ID: Allergen / D2340C00005
Conditions: Asthma
Keywords: Allergen Challenge, Asthma, Inhaled selective glucocorticoid receptor agonist (iSEGRA)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 21 Oct 2010 (estimated)
Results: Posted 2 Apr 2015

Clinical summary

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

The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: AZD5423, Drug: PlaceboAZD5423 75ug
2	Experimental	Drug: AZD5423, Drug: PlaceboAZD5423 300ug
3	Active comparator	Drug: Budesonide 200 microgram, Drug: PlaceboBudesonide 200 microgram
4	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

18-60 years of age
Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze
Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response
Positive skin prick test to common aeroallergens

Key exclusion criteria (5 listed)

Any clinically significant disease or disorder
Any clinically relevant abnormal finding at screening examinations
Smoker or ex-smoker who has stopped smoking < 12 months prior to study start
Worsening of asthma or respiratory infection within 6 weeks from visit 1
Allergen-specific immunotherapy within 6 months prior to visit 1

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
AZD5423Suspension for nebulisation once daily 7 days	Drug	1, 2
Budesonide 200 microgramAlso: PulmicortDry powder for inhalation twice daily 7 days	Drug	3
PlaceboSolution for nebulisation once daily 7 days	Drug	3, 4
PlaceboSolution for nebulisation once daily 7 days	Drug	1, 2, 4

Primary outcome

Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
Time frame: From Randomization to end of treatment
LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1

8 secondary outcomes

Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge
Time frame: From Randomization to end of treatment
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
Time frame: From Randomization to end of treatment
Airway Hyperresponsiveness by Assessment of Methacholine PC20
Time frame: Day 1 (pre-dose)
Airway Hyperresponsiveness by Assessment of Methacholine PC20
Time frame: Day 5 ([post-dose] pre allergen challenge)
Airway Hyperresponsiveness by Assessment of Methacholine PC20
Time frame: Day 7 ([post-dose] 24 hours post allergen challenge)
Changes in Sputum Eosinophils Differentials (Percentage)
Time frame: Day 5 (post dose)
Changes in Sputum Eosinophils Differentials (Percentage)
Time frame: Day 6 ([post dose] 7 hours post allergen challenge)
Changes in Sputum Eosinophils Differentials (Percentage)
Time frame: Day 7 ([post dose] 24 hours post allergen challenge)

Results and safety

Results posted to the registry on 2 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACBP	1	1
APBC	4	4
BACP	3	3
BPCA	1	1
CAPB	1	1
CBAP	1	1
CBPA	3	3
PBAC	1	1
PCAB	4	4
PCBA	1	1

Primary outcome: Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1

Time frame: From Randomization to end of treatment. Geometric mean (Full Range). Unit: Percentage

Measure	Arm 1 - 75ug AZD5423 n = 19	Arm 2 - 300ug AZD5423 n = 19	Arm 3 - 2x200ug Budesonide n = 19	Arm 4 - Placebo n = 19
Value	90.97 (73.20 to 100.00)	91.32 (76.80 to 101.60)	87.28 (56.60 to 103.20)	85.83 (69.60 to 102.80)

Population analysed: PD Analysis set

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 - 75ug AZD5423	0 of 19 (0%)	8 of 19 (42.1%)	Not reported
Arm 2 - 300ug AZD5423	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Arm 3 - 2x200ug Budesonide	0 of 19 (0%)	9 of 19 (47.4%)	Not reported
Arm 4 - Placebo	0 of 20 (0%)	9 of 20 (45%)	Not reported

Limitations and caveats (from the sponsor): Of the 27 patients enrolled, 20 (74.1%) patient were randomised to receive a treatment sequence consisting of 4 different treatment in random order. 19 patients completed each individual treatment period and 17 patients completed all 4 treatment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25473939Gauvreau GM, Boulet LP, Leigh R, Cockcroft DW, Killian KJ, Davis BE, Deschesnes F, Watson RM, Swystun V, Mardh CK, Wessman P, Jorup C, Aurivillius M, O'Byrne PM. A nonsteroidal glucocorticoid receptor agonist inhibits allergen-induced late asthmatic responses. Am J Respir Crit Care Med. 2015 Jan 15;191(2):161-7. doi: 10.1164/rccm.201404-0623OC.
CSR SynopsisLink provided by the sponsor.

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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.

Christer Hultquist study director

AstraZeneca R&D, Mölndal, Sweden

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD5423 and Budesonide 200 microgram in people with Asthma, run by AstraZeneca at 4 sites in Canada.

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 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 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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 2 Apr 2015). 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?

Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1 (time frame: From Randomization to end of treatment). 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 NCT01225549, 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 2 Apr 2015.