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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

Aclidinium bromide 200 μg once-daily by inhalation

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Efficacy and safety of LAS 34273 in patients with moderate to severe stable chronic obstructive pulmonary disease(COPD)

NCT ID

Therapeutic Area

Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

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Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks

Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks

Age Categorical

Age Continuous

Gender, Male/Female

Region of Enrollment

Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.

Trough FEV1 (L) at 28 Weeks on Treatment

Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.

Time to first moderate or severe COPD exacerbation at 52 Weeks on Treatment

Yes (% Patients with 4-unit decrease)

No (% Patients without 4-unit decrease)

Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score

Percentage of patients who achieved at least a 4-unit decrease from baseline in the SGRQ total score at 52 weeks on treatment

Trough FEV1 (L) at 12 Weeks on Treatment

Overall Study

Following a screening visit, patients entered a 14-day run-in period during which they used inhaled salbutamol on an as needed basis. Patients also stopped taking any other COPD medications prohibited by the study protocol. The 14-day run-in period was used to assess the stability of disease and established the patient’s baseline characteristics.

AstraZeneca Clinical

Time to first moderate or severe exacerbation:
Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.

Arms	Assigned Interventions
Experimental: Aclidinium 200 μg once-daily Aclidinium bromide 200 μg once-daily by inhalation	Drug: Aclidinium bromide Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
Placebo Comparator: Placebo Placebo by inhalation	Drug: Placebo Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Efficacy and safety of LAS 34273 in patients with moderate to severe stable chronic obstructive pulmonary disease(COPD)

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

Sponsor web site

Co-Sponsor web site

M-34273-31_CSR_Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator