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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 primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD

Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 weeks in patients on background Budesonide/Formoterol

2 x matched placebo to oral tablet bd for 12 weeks

Research Site

A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally twice daily to subjects with Chronic Obstructive Pulmonary Disease (COPD) on treatment with Budesonide/Formoterol

Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

End of treatment value  - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

Age Continuous

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.

Baseline pre-bronchodilator FEV1 (L)

End-value pre-bronchodilator FEV1 (L)

Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.

Post-bronchodilator FEV1 (L) - baseline

Post-bronchodilator FEV1 (L) - end-value

Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

Pre-bronchodilator FVC (L) - baseline

Pre-bronchodilator FVC (L) - end-value

Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.

Post-bronchodilator FVC (L) - baseline

Post-bronchodilator FVC (L) - end-value

Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

Baseline pre-bronchodilator FEV6 (L)

End-value pre-bronchodilator FEV6 (L)

Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.

Baseline post-bronchodilator FEV6 (L)

End-value post-bronchodilator FEV6 (L)

Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

Baseline pre-bronchodilator FEF25-75% (L/sec)

End-value pre-bronchodilator FEF25-75% (L/sec)

Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.

Baseline post-bronchodilator FEF25-75% (L/sec)

End-value post-bronchodilator FEF25-75% (L/sec)

Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

Pre-bronchodilator IC (L) - baseline

Pre-bronchodilator IC (L) - end-value

Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.

Post-bronchodilator IC (L) - baseline

Post-bronchodilator IC (L) - end-value

Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.

PEF - Baseline measured by patient at home (L/min) in the morning

PEF - End-value measured by patient at home (L/min) in the morning

Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.

FEV1 - Baseline measured by patient at home (L) in the morning

FEV1 - End-value measured by patient at home (L) in the morning

EXAcerbations of Chronic pulmonary disease Tool, patient
questionnaire as a measure of respiratory symptoms (reported as
units on a 0 (best health status) to 100 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.

EXACT - Baseline total score

EXAcerbations of Chronic pulmonary disease Tool, patient
questionnaire as a measure of respiratory symptoms (reported as
units on a 0 (best health status) to 100 (worst possible status) scale).

EXACT - End-value total score

Breathlessness, Cough and Sputum Scale, patient reported
questionnaire as a measure of respiratory symptoms (reported on a 0
(best health status) to 12 (worst possible status) scale).
Baseline is the mean of last 10 days of data before start of treatment.

BCSS - Baseline total score

Breathlessness, Cough and Sputum Scale, patient reported
questionnaire as a measure of respiratory symptoms (reported on a 0
(best health status) to 12 (worst possible status) scale).

BCSS - End-value total score

Sputum Colour as assessed by the Bronkotest scale, reported on a scale
from 1 - clear (best health status) to 5 - dark green (worst possible health
status).

Sputum colour - Baseline

Sputum Colour as assessed by the Bronkotest scale, reported on a scale
from 1 - clear (best health status) to 5 - dark green (worst possible health
status). End of treatment week 12

Sputum colour - End value

Daily average of number of inhalations of reliever medication

Use of reliever medication

Incremental shuttle walk test - Baseline

Incremental shuttle walk test - End value

Endurance shuttle walk test - Baseline

Assessed at vist 6  -( last on treatment clinic visit)

Endurance shuttle walk test - End value

St George's Respiratory Questionnaire for Chronic Obstructive
Pulmonary Disease, as a measure of Quality of Life (reported on a
scale from 0 (best health status) to 100(worst possible status)).

St George's Respiratory Questionnaire (COPD) - overall score at baseline

St George's Respiratory Questionnaire for Chronic Obstructive
Pulmonary Disease, as a measure of Quality of Life (reported on a
scale from 0 (best health status) to 100(worst possible status)).Questionaire assessed on vist 6  -( last on treatment clinic visit)

St George's Respiratory Questionnaire (COPD) - end-value overall score

Number of patients having a clinic defined disease exacerbation.

Exacerbations - Clinic defined

Overall Study

3- or 4-week run-in period on budesonide/formoterol twice daily to stabilise patients on maintenance therapy before randomisation. Patients already on budesonide/formoterol required a 3-week run-in period and patients on ICS as monotherapy or in combination with any long-acting bronchodilator required a 4-week run-in period.

Arms	Assigned Interventions
Experimental: 1	Drug: AZD9668 2 x 30 mg oral tablets bd for 12 weeks
Placebo Comparator: 2	Drug: Placebo 2 x matched placebo to oral tablet bd for 12 weeks

Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 weeks in patients on background Budesonide/Formoterol

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=236&filename=CSR-D0520C00020.pdf

CSR-D0520C00020.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator