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

NCT01225549 | Completed Phase 2 Results

• 1 other identifier: D2340C00005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Asthma

Keywords

Allergen Challenge; Asthma; Inhaled selective glucocorticoid receptor agonist (iSEGRA)

Outcome Measures

Primary Outcomes (1)

• 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

  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

  From Randomization to end of treatment

• Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge

  From Randomization to end of treatment

• Airway Hyperresponsiveness by Assessment of Methacholine PC20

  Day 1 (pre-dose)

• Airway Hyperresponsiveness by Assessment of Methacholine PC20

  Day 5 ([post-dose] pre allergen challenge)

• Airway Hyperresponsiveness by Assessment of Methacholine PC20

  Day 7 ([post-dose] 24 hours post allergen challenge)

Study Arms (4)

1

EXPERIMENTAL

AZD5423 75ug

Drug: AZD5423; Drug: Placebo

2

EXPERIMENTAL

AZD5423 300ug

Drug: AZD5423; Drug: Placebo

3

ACTIVE COMPARATOR

Budesonide 200 microgram

Drug: Budesonide 200 microgram; Drug: Placebo

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD5423 DRUG

Suspension for nebulisation once daily 7 days

1; 2

Budesonide 200 microgram DRUG

Dry powder for inhalation twice daily 7 days

Also known as: Pulmicort

3

Placebo DRUG

Solution for nebulisation once daily 7 days

3; 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Calgary, Alberta, Canada

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 25473939 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Interventions

2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide; Budesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Christer Hultquist

  AstraZeneca R&D, Mölndal, Sweden

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 21, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 2, 2015
• Results First Posted: April 2, 2015

Record last verified: 2015-03

Locations

CA (4)