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

Aclidinium bromide 400 μg twice-daily by inhalation

Tiotropium 18 μg once-daily by inhalation

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

Efficacy of aclidinium bromide administered in Chronic Obstructive Pulmonary Disease (COPD) patients

NCT ID

Therapeutic Area

Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.

Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.

Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.

Almirall Investigational Site #1

Almirall Investigational Site #2

Age Categorical

Age Continuous

Gender, Male/Female

Region of Enrollment

Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1

Change from baseline in normalised forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-12 hr at Day 15 on treatment.

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment

Overall Study

Treatment Period 1

Treatment Period 2

Treatment Period 3

Eligible patients had at least a 5-day run-in period (and a maximum of 9 days) to assess patient’s clinical stability.

Arms	Assigned Interventions
Experimental: Aclidinium 400 μg bid Aclidinium bromide 400 μg twice-daily by inhalation	Drug: Aclidinium bromide 400 μg bid Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.
Active Comparator: Tiotropium 18 μg once-daily Tiotropium 18 μg once-daily by inhalation	Drug: Tiotropium 18 μg once-daily Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.
Placebo Comparator: Placebo Placebo	Drug: Placebo Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.

Efficacy of aclidinium bromide administered in Chronic Obstructive Pulmonary Disease (COPD) patients

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

Almirall Corporate Website

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator