Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

Chronic Obstructive Pulmonary Disease Clinical Trial

— ALIGHT-COPD  

Official title:

Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078623
• Other study ID #: M/40464/26
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2010
• Last updated: May 18, 2016
• Start date: February 2010
• Est. completion date: September 2010

Study information

• Verified date: May 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of HealthRomania: National Authority for Scientific Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.

Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.

2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification

3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.

4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg 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%).

5. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).

6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.

7. Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment

Exclusion Criteria:

1. History or current diagnosis of asthma or exercise-induced bronchospasm.

2. Clinically significant respiratory conditions at the time of Inform Consent signature

3. Hospitalisation due to COPD exacerbation within the previous 3 months.

4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.

5. Patient who has a resting systolic blood pressure = 200 mmHg, a resting diastolic blood pressure = 120 mmHg or a resting heart rate = 105 bpm at screening visit.

6. Clinically significant cardiovascular conditions

7. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.

8. Presence of narrow-angle glaucoma.

9. QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,

10. Patient who does not maintain regular day/night, waking/sleeping cycles

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium and Formoterol
Fixed Dose (I)
• Placebo
Placebo control
• Formoterol
Formoterol dose
• Aclidinium
Aclidinium dose
• Aclidinium and Formoterol
Fixed Dose (II)

Locations

Country	Name	City	State
Czech Republic	Almirall Investigational Sites#3	Hlucin
Czech Republic	Almirall Investigational Sites#1	Praha
Czech Republic	Almirall Investigational Sites#2	Praha
Czech Republic	Almirall Investigational Sites#5	Rokycany
Germany	Almirall Investigational Sites#3	Berlin
Germany	Almirall Investigational Sites#5	Berlín
Germany	Almirall Investigational Sites#2	Donaustauf
Germany	Almirall Investigational Sites#6	Lübeck
Germany	Almirall Investigational Sites#4	Schwerin
Hungary	Almirall Investigational Sites#2	Komarom
Hungary	Almirall Investigational Sites#3	Komlo
Hungary	Almirall Investigational Sites#1	Szarvas
Poland	Almirall Investigational Sites#1	Krakow
Poland	Almirall Investigational Sites#2	Krakow
Poland	Almirall Investigational Sites#4	Lublin
Poland	Almirall Investigational Sites#3	Olawa
Romania	Almirall Investigational Sites#13	Bucuresti
Romania	Almirall Investigational Sites#4	Bucuresti
Romania	Almirall Investigational Sites#9	Bucuresti
Romania	Almirall Investigational Sites#10	Cluj
Romania	Almirall Investigational Sites#1	Constanta
Romania	Almirall Investigational Sites#7	Deva
Romania	Almirall Investigational Sites#14	Iasi
Romania	Almirall Investigational Sites#3	Iasi
Romania	Almirall Investigational Sites#6	Iasi
Romania	Almirall Investigational Sites#8	Oradea
Romania	Almirall Investigational Sites#5	Tg Mures
Romania	Almirall Investigational Sites#12	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 AUC 0-12h		Day 14	No
Secondary	morning pre-dose FEV1 and morning peak FEV1		Day 14	No

External Links

•   Almirall Corporate Website
•   CSR Synopsis