Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate (ALIGHT-COPD)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01078623
First received: March 1, 2010
Last updated: November 5, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium and Formoterol
Drug: Placebo
Drug: Formoterol
Drug: Aclidinium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • FEV1 AUC 0-12h [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morning pre-dose FEV1 and morning peak FEV1 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Formoterol
Formoterol
Drug: Formoterol
Formoterol dose
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo control
Experimental: Aclidinium and Formoterol (I)
Fixed dose combination
Drug: Aclidinium and Formoterol
Fixed Dose (I)
Experimental: Aclidinium and Formoterol (II)
Fixed dose combination
Drug: Aclidinium and Formoterol
Fixed dose (II)
Experimental: Aclidinium
Aclidinium
Drug: Aclidinium
Aclidinium dose

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078623

Locations
Czech Republic
Almirall Investigational Sites#3
Hlucin, Czech Republic, 748 21
Almirall Investigational Sites#1
Praha, Czech Republic, 130 00
Almirall Investigational Sites#2
Praha, Czech Republic, 150 06
Almirall Investigational Sites#5
Rokycany, Czech Republic, 337 01
Germany
Almirall Investigational Sites#3
Berlin, Germany, 14059
Almirall Investigational Sites#5
Berlín, Germany, 10717
Almirall Investigational Sites#2
Donaustauf, Germany, 93093
Almirall Investigational Sites#6
Lübeck, Germany, 23538
Almirall Investigational Sites#4
Schwerin, Germany, 19055
Hungary
Almirall Investigational Sites#2
Komarom, Hungary, 2900
Almirall Investigational Sites#3
Komlo, Hungary, 7300
Almirall Investigational Sites#1
Szarvas, Hungary, 5540
Poland
Almirall Investigational Sites#1
Krakow, Poland, 31-501
Almirall Investigational Sites#2
Krakow, Poland, 31-023
Almirall Investigational Sites#4
Lublin, Poland, 20-718
Almirall Investigational Sites#3
Olawa, Poland, 55-200
Romania
Almirall Investigational Sites#4
Bucuresti, Romania, 12384
Almirall Investigational Sites#9
Bucuresti, Romania, 11025
Almirall Investigational Sites#13
Bucuresti, Romania, 22328
Almirall Investigational Sites#10
Cluj, Romania, CLUJ
Almirall Investigational Sites#1
Constanta, Romania, 900002
Almirall Investigational Sites#7
Deva, Romania, 330084
Almirall Investigational Sites#6
Iasi, Romania, 700115
Almirall Investigational Sites#3
Iasi, Romania, 700305
Almirall Investigational Sites#14
Iasi, Romania, 700381
Almirall Investigational Sites#8
Oradea, Romania, 410176
Almirall Investigational Sites#5
Tg Mures, Romania, 540072
Almirall Investigational Sites#12
Timisoara, Romania, 0
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
  More Information

Additional Information:
No publications provided

Responsible Party: Estrella Garcia, Almirall
ClinicalTrials.gov Identifier: NCT01078623     History of Changes
Other Study ID Numbers: M/40464/26
Study First Received: March 1, 2010
Last Updated: November 5, 2010
Health Authority: Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Romania: National Authority for Scientific Research

Keywords provided by Almirall, S.A.:
Bronchitis
Chronic
Emphysema

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Formoterol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014