EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

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.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.

A dose range finding study to evaluate the efficacy and safety of AZD9668 administered orally at three dose levels to patients with Chronic Obstructive Pulmonary Disease (COPD) on treatment with tiotropium

2 x 30 mg oral tablets twice daily (bid) for 12 weeks

2 x 10 mg oral tablets twice daily (bid) for 12 weeks

2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks

2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks

Research Site

A 12-week, randomised, double-blind, placebo-controlled, parallel group, multinational, phase IIb dose range finding study to evaluate the efficacy and safety of AZD9668 administered orally at 3 dose levels to patients with Chronic Obstructive Pulmonary Disease (COPD) on treatment with tiotropium

Forced Expiratory Volume in 1 second (L) 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 (L) 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 (L) 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 (L) 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

Inspiratory Capacity (L) 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 (L) 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). Last 6 weeks on treatment.

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). Last 6 weeks on treatment

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

Six-minute walk test - distance walked at baseline (m)

distance walked on vist 6  - last on treatment clinic visit

Six-minute walk test - end-value distance walked (m)

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

Patients were stabilised on maintenance therapy (tiotropium, 18 micrograms od) during a 2-week run-in period before randomisation.

Arms	Assigned Interventions
Active Comparator: 1 AZD9668 active treatment	Drug: AZD9668 2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Active Comparator: 2 AZD9668 active treatment	Drug: AZD9668 2 x 10 mg oral tablets twice daily (bid) for 12 weeks
Active Comparator: 3 AZD9668 active treatment	Drug: AZD9668 2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
Placebo Comparator: 4 AZD9668 placebo treatment	Drug: AZD9668 Placebo 2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks

A dose range finding study to evaluate the efficacy and safety of AZD9668 administered orally at three dose levels to patients with Chronic Obstructive Pulmonary Disease (COPD) on treatment with tiotropium

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=234&filename=CSR-D0520C00012.pdf

CSR-D0520C00012.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator