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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A 3-month, Double-blind, Double-dummy, Randomised, Multinational, Multicenter, 2-arm Parallel-group Study Comparing the Efficacy and Safety of Formoterol-HFA pMDI 12µg Twice Daily and Formoterol-DPI 12µg Twice Daily, in Patients With Stable Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972140
• Other study ID #: RA-PR-3301-011-04
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2009
• Last updated: December 12, 2011
• Start date: August 2005
• Est. completion date: October 2006

Study information

• Verified date: December 2011
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyPoland: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Phase III, multicenter, multinational, double-blind, double-dummy, randomised, 2-arm parallel-group, 3-month study in patients with stable COPD.

Comparison in terms of efficacy and safety of the two formulations of formoterol administered as 24µg/day in a bid regimen

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: October 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Patients treated with depot corticosteroids in the three months preceding the screening visit and during the 14-week study period.

• Changes in dose, schedule, formulation or product of an inhaled or nasal corticosteroid and oral modified-release theophylline within one month of screening visit and during the 14 week study period

• Patients treated with inhaled long-acting ß2-agonists during the 14-week study period.

• Short-acting ß2-agonists on regular use during the 14-week study period 8 hours preceding the screening visit

• Short-acting anticholinergic medications during the 14-week study period

• Long-acting anticholinergic medications (e.g. tiotropium) during the 14-week study period.

• Inhaled fixed combinations of a short-acting ß2-agonist and a short-acting anticholinergic medication (e.g. Combivent) during the 14-week study period

• Inhaled fixed combinations of an inhaled corticosteroid and a long-acting ß2-agonist (e.g.Seretide, Symbicort) during the 14-week study period.

• Long-acting antihistamines (e.g. Astemizole, Terfenadine) in the three months preceding the screening visit and during the 14-week study period.

• Tricyclic antidepressants, monoamine oxidase inhibitors (MAOI) and other drugs known to prolong the QTc interval during the 14-week study period.

• ß-blockers in the week preceding the screening visit and during the 14-week study period.

• Intolerance to inhaled ß2-adrenergic agents.

• History of intolerance or allergic reactions to any of the pMDI and DPI excipients.

• Patients who had evidence of alcohol or substance abuse, not compliant with the study protocol or not compliant with the study treatments.

• Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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:
• Formoterol
Formoterol-HFA pMDI 12µg twice daily
• Formoterol
Formoterol-DPI 12 µg twice daily

Locations

Country	Name	City	State
Poland	Prof. Iwona Graelewska Rzymowska	Lodz	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue		Every 6 weeks	No