Phase 2
Completed N=79
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Source: ClinicalTrials.gov NCT01120093 ↗Enrolled (actual)
79
Serious AEs
1.1%
Results posted
Sep 2012
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment — 0.128; 0.151; 0.183; 0.184 Liters
Summary
The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment |
0.128; 0.151; 0.183; 0.184; -0.026 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment |
0.044; 0.047; 0.086; 0.141; -0.103 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment |
0.088; 0.100; 0.133; 0.163; -0.062 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment |
0.081; 0.089; 0.130; 0.123; -0.025 | — |
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant, non-lactating females aged ≥ 40.
- Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
- Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
- Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of salbutamol is 30% < FEV1 <80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
- Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
- Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.
Exclusion Criteria
- History or current diagnosis of asthma.
- Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature
- Hospitalisation due to COPD exacerbation within the previous 3 months.
- Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
- Clinically significant cardiovascular conditions
- Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
- Presence of narrow-angle glaucoma.
- QTcB) above 470 milliseconds in the ECG performed at Screening Visit,
- Patient who does not maintain regular day/night, waking/sleeping cycles
Data sourced from ClinicalTrials.gov (NCT01120093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.