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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 investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).

A phase II , placebo-controlled study to assess efficacy of 28 day oral AZD9668 in patients with cystic fibrosis

60 mg, oral tablet, twice daily for 28 days

Match placebo to 60 mg, oral tablet, twice daily for 28 days

Research Site

A phase II, randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy of 28 day oral administration of AZD9668 in patients with cystic fibrosis

Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)

Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.

Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.

Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.

FEF25-75%  (L) as a measure of lung function. Change from Baseline to day 28.

Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.

Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment

Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment

The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.

Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.

Age Continuous

Two patients excluded from analysis set. No data for patient
who prematurely discontinued and for patient who did not receive any study medication.

Gender, Male/Female

The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.

Arms	Assigned Interventions
Experimental: AZD9668	Drug: AZD9668 60 mg, oral tablet, twice daily for 28 days
Placebo Comparator: Placebo	Drug: AZD9668 Placebo equivalent Match placebo to 60 mg, oral tablet, twice daily for 28 days

A phase II , placebo-controlled study to assess efficacy of 28 day oral AZD9668 in patients with cystic fibrosis - INCA

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=232&filename=CSR-D0520C00009.pdf

CSR-D0520C00009.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator