Aclidinium/Formoterol Fixed Combination Dose Finding Study

NCT00626522 | Completed Phase 2 Results

• 2 other identifiers: M/273FO/232007-004435-30
• Study Type: interventional
• Target: 808
• Locations: 4 countries
• Sites: 9

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Bronchitis; Chronic; Emphysema; Smokers or ex-Smokers

Outcome Measures

Primary Outcomes (1)

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

  Baseline and treatment Week 4

Secondary Outcomes (4)

• Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)

  Baseline and treatment Week 4

• Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)

  Baseline and treatment Week 4

• Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-3 hr

  Baseline and treatment Week 4

• Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-6 hr

  Baseline and treatment Week 4

Study Arms (6)

1

EXPERIMENTAL

Drug: Aclidinium bromide and formoterol

2

EXPERIMENTAL

Drug: Aclidinium bromide and formoterol

3

EXPERIMENTAL

Drug: Aclidinium bromide and formoterol

4

PLACEBO COMPARATOR

Drug: Aclidinium bromide and formoterol placebo

5

PLACEBO COMPARATOR

Drug: Aclidinium bromide and formoterol placebo

6

PLACEBO COMPARATOR

Drug: Aclidinium bromide and formoterol placebo

Interventions

Aclidinium bromide and formoterol DRUG

once daily

1; 2; 3

Aclidinium bromide and formoterol placebo DRUG

once daily

4; 5; 6

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• (A female was considered to be of childbearing potential unless she had a hysterectomy, was at least one year post-menopause or had undergone tubal ligation. All women of childbearing potential were to have a negative serum pregnancy test at the Screening Visit).
• 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.
• Pack-years were calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person had smoked. For example, a person who smoked 40 cigarettes a day and had smoked for 10 years would have had a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history).
• Patients smoking other tobacco types were not allowed, unless they met the cigarette criterion as well.
• 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.

You may not qualify if:

• 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:
• Use of long-term oxygen therapy \>5 h/day,
• Known active tuberculosis,
• History of interstitial lung or pulmonary thromboembolic disease,
• Pulmonary resection during the past 12 months,
• History of life-threatening COPD,
• History of bronchiectasis secondary to respiratory diseases others than COPD (eg, cystic fibrosis, Kartagener's syndrome, etc),
• Patients who in the Investigator's opinion may have needed to stop or start pulmonary rehabilitation or undergo a thoracotomy during the trial,
• 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:
• Myocardial infarction within the previous 6 months,
• Unstable arrhythmia which has required changes in the pharmacological therapy or other intervention within the previous 12 months, or newly diagnosed arrhythmia within the previous 3 months.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Taichung, Australia

Location

Research Site

Taipei, Australia

Location

Research Site

Moscow, Czechia

Location

Research Site

Saint Petersburg, Poland

Location

Research Site

St-Petersburg, Poland

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Saratov, Russia

Location

Research Site

Yaroslavl, Russia

Location

Related Links

• Sponsor website
• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchiolitis Obliterans Syndrome; Emphysema; Smoking Cessation

Interventions

aclidinium bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Graft vs Host Disease; Immune System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Esther Garcia
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 16, 2016
• Results First Posted: August 8, 2016

Record last verified: 2016-09

Locations

RU (4); PL (2); CZ (1); AU (2)