Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT00972140 | Completed Phase 3

• 1 other identifier: RA-PR-3301-011-04
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the clinical equivalence of formoterol-HFA pMDI 12µg/actuation administered twice daily to formoterol DPI 12µg/capsule delivered by the Aerolizer inhaler and administered twice daily in patients with COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Patients with stable COPD

Outcome Measures

Primary Outcomes (1)

• 12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatment

  Every 6 weeks

Secondary Outcomes (1)

• Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue

  Every 6 weeks

Study Arms (2)

Formoterol-HFA

EXPERIMENTAL

Formoterol-HFA pMDI 12µg twice daily

Drug: Formoterol

Formoterol-DPI

ACTIVE COMPARATOR

Formoterol-DPI 12µg twice daily

Drug: Formoterol

Interventions

Formoterol DRUG

Formoterol-HFA pMDI 12µg twice daily

Also known as: Atimos

Formoterol-HFA

Eligibility Criteria

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

You may qualify if:

• Male and female patients who gave written informed consent.
• Diagnosis of stable COPD according to the recommendations of the -Diagnosis of stable COPD according to the recommendations of the National Heart Lung and Blood Institute (NHLBI) Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, Edition 2003
• Age 40 years or older. Male and female patients who gave written informed consent
• History of a progressive nature of symptoms and a complaint of dyspnoea at least on exertion.
• Current or previous smoker \[in both cases with a cumulative exposure to cigarette smoke of more than 20 pack-years
• Pre-bronchodilator baseline 40% \> FEV1 \< 70% of the predicted normal value
• Absolute value FEV1 \> 0.9 L.
• FEV1/FVC \< 70% (ERS criteria for predicted normal value).
• FEV1 reversibility test 30 minutes following inhalation of 400 μg of salbutamol pMDI
• A cooperative attitude and ability to be trained to use correctly the pMDI and the Aerolizer® inhaler

You may not qualify if:

• Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with childbearing potential (e.g. contraceptive methods other than oral contraceptives, IUD, tubal ligature).
• Current or past diagnosis of asthma.
• History of allergic rhinitis or other atopic disease (e.g. eczema).
• Largely reversible airflow obstruction.
• Onset of obstructive symptoms early in life (i.e. childhood).
• Variability of symptoms from day to day and frequent symptoms at night and early morning.
• A total blood eosinophil count higher than 500/μL.
• Significant and unstable concomitant cardiovascular, renal, hepatic, gastrointestinal,neurological, endocrine, metabolic, musculo-skeletal, neoplastic, respiratory or other clinically significant disease
• Clinical significant laboratory abnormalities indicating a significant or unstable concomitant disease.
• QTc interval (Bazett formula) higher than 460 msec
• Total 24 hours respiratory symptom score (day-time and night-time) \> 2 on at least 4 consecutive days
• Lower respiratory tract infection within one month before screening visit
• Hospitalisation or emergency room treatment for an acute COPD exacerbation in the month before screening visit
• Long-term oxygen therapy.
• Patients treated with oral or injectable corticosteroids and antibiotics for a COPD exacerbation and/or a lower respiratory tract infection in the month preceding the screening visit and during the run-in period of the study.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Prof. Iwona Graelewska Rzymowska

Lodz, Lódz, 91-520, Poland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Iwona Graelewska Rzymowska, Prof

  Clinic Pneumology and Allergology Lodz Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: August 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: October 1, 2006
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

PL (1)