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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

The study will evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen

Suspension for nebulisation once daily 7 days

Dry powder for inhalation twice daily 7 days

Solution for nebulisation once daily 7 days

Research Site

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

Age Continuous

Gender, Male/Female

Race, Customized

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

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

Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge compared to pre allergen challenge FEV1

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

Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge

AUC over 0-3 (Average EAR)

AUC over 3-7 (Average LAR)

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

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

Airway hyperresponsiveness by assessment of methacholine PC20

Airway Hyperresponsiveness by Assessment of Methacholine PC20

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)

Changes in Sputum Eosinophils Differentials (Percentage)

Period 1 - First treatment period

Period 2 - Washout

Period 3 - Second treatment period

Period 4 - Washout

Period 5 - Third treatment period

Period 6 - Washout

Period 7 - Fourth treatment period

Total 27 patients enrolled, 20 (74.1%) patients were randomised to receive a treatment sequence consisting of 4 different treatment in random order. From 20 randomised patients, 18 (90%) patients completed the study and 2 (10%) patients were withdrawn from the study due to consumption of disallowed medication

Arms	Assigned Interventions
Experimental: 1 AZD5423 75ug	Drug: AZD5423 Suspension for nebulisation once daily 7 days Drug: Placebo Solution for nebulisation once daily 7 days
Experimental: 2 AZD5423 300ug	Drug: AZD5423 Suspension for nebulisation once daily 7 days Drug: Placebo Solution for nebulisation once daily 7 days
Active Comparator: 3 Budesonide 200 microgram	Drug: Budesonide 200 microgram Dry powder for inhalation twice daily 7 days Other Name: Pulmicort Drug: Placebo Solution for nebulisation once daily 7 days
Placebo Comparator: 4 Placebo	Drug: Placebo Solution for nebulisation once daily 7 days Drug: Placebo Solution for nebulisation once daily 7 days

The study will evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen - Allergen

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