CompletedPhase 2

Aclidinium/Formoterol Fixed Combination Dose Finding Study

Australia, Czechia, Poland808 participantsStarted 2008-02

Plain-language summary

The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult males or non-pregnant, non-lactating females aged between 40 and 80 years old, both inclusive. Women of childbearing potential were allowed to enter the trial only if they used two medically approved contraceptive measures (ie, mechanical and pharmacological).
✓. Patients with a clinical diagnosis of stable moderate to severe COPD (stages II and III) according to the GOLD 2006 classification (http://www.goldcopd.com).
✓. Current or ex-cigarette smoker with a smoking history of at least 10 pack-years.
✓. Patients whose Forced Expiratory Volume in 1 second (FEV1) at the Screening Visit measured between 30-45 minutes post inhalation of 400 μg of salbutamol was 30% ≤FEV1 \<80% of the predicted normal value (ie, 100 x Post-salbutamol FEV1/Predicted FEV1 \<80% and ≥30%). (Predicted normal values used for calculation purposes were to be based on European Community for Steel and Coal predicted values)
✓. Patients whose FEV1/Forced Vital Capacity (FVC) at the Screening Visit measured between 30- 45 minutes post inhalation of 400 μg of salbutamol was \<70% (ie, 100 x Post-salbutamol FEV1/FVC \<70%).
✓. Patients whose COPD symptoms and FEV1 values at the time of randomisation were stable compared to the Screening Visit, according to the Investigator's medical judgment.
✓. Patients who were eligible and able to participate in the trial and who consented to do so in writing after the purpose and nature of the investigation had been explained.

✕. History or current diagnosis of asthma, allergic rhinitis or atopy, or exercise-induced bronchospasm.
✕. Eosinophil count ≥600 cells/mm3.
✕. Clinically significant respiratory conditions at the time of Screening Visit defined as:
✕. Hospitalisation due to COPD exacerbation, up to the 3 months prior to the Screening Visit.
✕. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract), up to the 6 weeks prior to the Screening Visit.
✕. Clinically significant cardiovascular conditions at the time of Screening Visit defined as:
✕. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction. (However, patients who had a diagnosis of these conditions but without symptoms due to stable concomitant medication for its treatment were allowed to enter trial).
✕. Presence of narrow-angle glaucoma.

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-12 hr

Timeframe: Baseline and treatment Week 4

NCT IDNCT00626522

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-11

Results submitted2016-06-28

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult males or non-pregnant, non-lactating females aged between 40 and 80 years old, both inclusive. Women of childbearing potential were allowed to enter the trial only if they used two medically approved contraceptive measures (ie, mechanical and pharmacological).
✓. Patients with a clinical diagnosis of stable moderate to severe COPD (stages II and III) according to the GOLD 2006 classification (http://www.goldcopd.com).
✓. Current or ex-cigarette smoker with a smoking history of at least 10 pack-years.
✓. Patients whose Forced Expiratory Volume in 1 second (FEV1) at the Screening Visit measured between 30-45 minutes post inhalation of 400 μg of salbutamol was 30% ≤FEV1 \<80% of the predicted normal value (ie, 100 x Post-salbutamol FEV1/Predicted FEV1 \<80% and ≥30%). (Predicted normal values used for calculation purposes were to be based on European Community for Steel and Coal predicted values)
✓. Patients whose FEV1/Forced Vital Capacity (FVC) at the Screening Visit measured between 30- 45 minutes post inhalation of 400 μg of salbutamol was \<70% (ie, 100 x Post-salbutamol FEV1/FVC \<70%).
✓. Patients whose COPD symptoms and FEV1 values at the time of randomisation were stable compared to the Screening Visit, according to the Investigator's medical judgment.
✓. Patients who were eligible and able to participate in the trial and who consented to do so in writing after the purpose and nature of the investigation had been explained.

✕. History or current diagnosis of asthma, allergic rhinitis or atopy, or exercise-induced bronchospasm.
✕. Eosinophil count ≥600 cells/mm3.
✕. Clinically significant respiratory conditions at the time of Screening Visit defined as:
✕. Hospitalisation due to COPD exacerbation, up to the 3 months prior to the Screening Visit.
✕. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract), up to the 6 weeks prior to the Screening Visit.
✕. Clinically significant cardiovascular conditions at the time of Screening Visit defined as:
✕. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction. (However, patients who had a diagnosis of these conditions but without symptoms due to stable concomitant medication for its treatment were allowed to enter trial).
✕. Presence of narrow-angle glaucoma.