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Completed

NCT Number: NCT01225549

The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild 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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

AZD5423

Drug

Suspension for nebulisation once daily 7 days

Budesonide 200 microgram

Drug

Dry powder for inhalation twice daily 7 days

Other names: Pulmicort

Placebo

Drug

Solution for nebulisation once daily 7 days

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

    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

Secondary outcomes

  1. 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

    Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1

  2. 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

    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

  3. Airway Hyperresponsiveness by Assessment of Methacholine PC20

    Time frame: Day 1 (pre-dose)

    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)

  4. Airway Hyperresponsiveness by Assessment of Methacholine PC20

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

    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)

  5. Airway Hyperresponsiveness by Assessment of Methacholine PC20

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

    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)

  6. Changes in Sputum Eosinophils Differentials (Percentage)

    Time frame: Day 5 (post dose)

    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)

  7. Changes in Sputum Eosinophils Differentials (Percentage)

    Time frame: Day 6 ([post dose] 7 hours post allergen challenge)

    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)

  8. Changes in Sputum Eosinophils Differentials (Percentage)

    Time frame: Day 7 ([post dose] 24 hours post allergen challenge)

    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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: Allergen

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 21, 2010
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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