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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01078623
First received: March 1, 2010
Last updated: September 27, 2016
Last verified: September 2016
  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: Parallel 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 AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14 [ Time Frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14 ] [ Designated as safety issue: No ]
    FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose


Secondary Outcome Measures:
  • Change From Baseline in Morning Pre-dose FEV1 at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes

  • Change From Baseline in Morning Peak FEV1 at Day 14 [ Time Frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14 ] [ Designated as safety issue: No ]
    FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose


Enrollment: 176
Study Start Date: February 2010
Study Completion Date: September 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   (Adult, Senior)
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
Research Site
Bucuresti, Czech Republic
Research Site
Constanta, Czech Republic
Research Site
Iasi, Czech Republic
Research Site
Tg Mures, Czech Republic
Romania
Research Site
Bucuresti, Romania
Research Site
Cluj Napoca, Romania
Research Site
Deva, Romania
Research Site
Iasi, Romania
Research Site
Oradea, Romania
Research Site
Timisoara, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, MD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01078623     History of Changes
Other Study ID Numbers: M/40464/26 
Study First Received: March 1, 2010
Results First Received: September 27, 2016
Last Updated: September 27, 2016
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 AstraZeneca:
Bronchitis
Chronic
Emphysema

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bromides
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
Anticonvulsants

ClinicalTrials.gov processed this record on December 08, 2016