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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 study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Study to assess the efficacy and safety of AZD1981 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Research Site

A 4 week double-blind, placebo-controlled, randomized, parallel group phase IIa study to assess the efficacy and safety of AZD1981 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Mean change in FEV1 from baseline to last measurement post dose

Mean change in Total CCQ from baseline to last measurement post dose

Age Continuous

Gender, Male/Female

One patient randomised to placebo withdrew consent immediately after the first dose of investigational product on the day of randomisation. No clinical measurements were performed and no reports of AEs were received for this patient. Since the patient is non-informative both in terms of efficacy and safety, he has been excluded from the analyses.

Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)

The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

FEV1

Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).

Clinical COPD Questionnaire

Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)

Forced Vital Capacity

Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)

Slow Vital Capacity

Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)

Inspiratory Capacity

Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)

FEF25%-75% 

Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).

COPD symptom sleep score

Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).

COPD symptom breathing score

Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).

COPD symptom cough score

Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).

COPD symptom sputum score

Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).

PEF (Peak Expiratory Flow) morning

Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).

PEF (Peak Expiratory Flow) evening

Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).

Total use of reliever

The number of participants that experienced at least one adverse event.

The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.

Adverse event

Overall Study

Alison Holt 

Mean change in FVC from baseline to last measurement post dose

Mean change in SVC from baseline to last measurement post dose

Mean change in IC from baseline to last measurement post dose

Mean change in FEF25%-75% from baseline to last measurement post dose

Mean change in COPD symptom sleep score from baseline to last measurement post dose

Mean change in COPD symptom breathing score from baseline to last measurement post dose

Mean change in COPD symptom cough score from baseline to last measurement post dose

Mean change in COPD symptom sputum score from baseline to last measurement post dose

Mean change in PEF morning from baseline to last measurement post dose

Mean change in PEF evening from baseline to last measurement post dose

Mean change in Total use of reliever from baseline to last measurement post dose

Arms	Assigned Interventions
Experimental: AZD1981 AZD1981 Oral tablet, twice daily	Drug: AZD1981 Oral tablet, twice daily
Placebo Comparator: Placebo Placebo Oral tablet, twice daily	Drug: Placebo Placebo Oral tablet, twice daily

Study to assess the efficacy and safety of AZD1981 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - Columbus

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=215&filename=CSR-D9831C00001.pdf

CSR-D9831C00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator