Formoterol Via pMDI HFA-134a Propellant or DPI in Partially Reversible Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.

First Received: August 26, 2008 No Changes Posted

Sponsor:	Chiesi Farmaceutici S.p.A.
Collaborators:	Vito Brusasco "Centro Dipartimentale di Fisiopatologia Respiratoria", University of Genoa, Italy (Co-ordinating centre) Giovanni Barisione "Unità Operativa di Medicina Preventiva e del Lavoro, Laboratorio di Fisiopatologia Respiratoria", S. Martino Hospital, Genoa, Italy Giorgio Canonica "Clinica di Malattie dell'Apparato Respiratorio e Allergologia, Dipartimento di Medicina Interna", University of Genoa, Italy Cardarelli Hospital Roberto Dal Negro "Unità Operativa di Pneumologia", Hospital of Bussolengo (Verona), Italy Leonardo Fabbri "Clinica di Malattie dell'Apparato Respiratorio", University of Modena, Italy Carlo Mereu "Struttura complessa di Pneumologia", S. Corona Hospital, Pietra Ligure (Savona), Italy Pierluigi Paggiaro "Servizio di Fisiopatologia Respiratoria, Dipartimento Cardiotoracico", University of Pisa, Italy Giorgio Scano "Unità Operativa di Riabilitazione Respiratoria, Fondazione Don Carlo Gnocchi ONLUS", Pozzolatico (FI), Italy.
Information provided by:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00742248

Purpose

The purpose of this study is to demonstrate equivalent efficacy between two different formulations of formoterol (pMDI using HFA-134 propellant and dry powder) on lung function in adult patients with partially reversible COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Formoterol Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Double Blind, Double Dummy, Multicentre, Randomised, Placebo- Controlled, Crossover Design Clinical Trial of 12 μg (Single Dose and Repeated Doses) Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant or DPI (Aerolizertm Inhaler) in Patients With Partially Reversible COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Arformoterol Tartrate HFA 227

U.S. FDA Resources

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:

FEV1 area under the curve (AUC) standardized for time [ Time Frame: 4 hours following the morning dose of study medication at the first visit of each treatment cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical equivalence in terms of FEV1 area under the curve (AUC) standardized for time [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Enrollment:	54
Study Start Date:	September 2004
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Formoterol pMDI	Drug: Formoterol pMDI 12 mcg/dose 1 dose in the morning and 1 dose in the evening Drug: Formoterol DPI 12 mcg/dose 1 dose in the morning and 1 dose in the evening Drug: Placebo Placebo pMDI/DPI 1 dose in the morning and 1 dose in the evening
B: Active Comparator Formoterol dry powder	Drug: Formoterol DPI 12 mcg/dose 1 dose in the morning and 1 dose in the evening Drug: Placebo Placebo pMDI/DPI 1 dose in the morning and 1 dose in the evening
C: Placebo Comparator Placebo pMDI DPI	Drug: Placebo Placebo pMDI/DPI 1 dose in the morning and 1 dose in the evening

Detailed Description:

The present study is aimed at investigating the effect of a single 12 µg dose and of a short 7-day course of formoterol HFA-134a, compared to a formoterol DPI formulation, on specific parameters that are appropriate for assessment of single-dose and short-term effects on COPD.

This study has been designed to assess the efficacy with the traditional use of FEV1. Furthermore, the use of other efficacy parameters such as changes in exertion tolerance and dyspnoea, dynamic and static volumes measured using a whole body plethysmograph, such as TLC, RV, IC and airways conductance sGAW has been included.

This is a double blind, double dummy, multicentre, randomised, placebo-controlled, cross-over study in at least 36 adult patients with partially reversible COPD. The two test treatments and placebo will be administered in a single and repeated (twice daily for 7 days) dose cycle (with a minimum 2 days and maximum 7 days of wash-out between each cycle).

Seven clinic visits in total will take place at the start and end of the run-in period, and at the first and at the last dose of each treatment cycle (with placebo and the two active treatment tests), with an acceptable variation of a maximum of ± 1 day in respect of the scheduled days at the end of each treatment cycle (i.e. treatment with placebo or active drug may range between 6 and 8 days).

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients of either sex aged > 40 years.
Clinical diagnosis of partially reversible COPD, with or without chronic symptoms, in line with the following recommendations of the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) (22):
Post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal values, and at least 0.7 L (if less than 0.7 L, FEV1 must be ≥ 40% of predicted normal value)
FEV1/FVC ratio < 70%.
Positive partial response to the reversibility test in the screening visit, defined as an increase from baseline value of at least 5% of the percentage of predicted normal value (post-dosing minus pre-dosing/pre-dosing x 100) in the FEV1 measurement 30 minutes following 4 puffs (4 x 100 µg) of inhaled salbutamol pMDI.
Current or past tobacco heavy smoking habits (defined as smoking for > 20 pack years, where 1 pack year = 20 cigarettes/day for 1 year or equivalent).
A cooperative attitude and ability to be trained to use correctly the pMDI and the AerolizerTM inhaler.
Written informed consent obtained.

Exclusion Criteria:

Evidence of COPD exacerbation and/or symptomatic infection of the airways in the previous 4 weeks requiring antibiotic therapy.
History of clinically significant disease whose sequelae and/or treatments can interfere with the results of the present study.
Presence of asthma.
Evidence of bronchiectases.
History of inadequate cardiac, hepatic and/or renal function.
History of coronary artery disease, myocardial infarction, cerebrovascular disease, cardiac arrhythmias, severe hypertension and diabetes mellitus.
Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, bradycardia (≤ 55 bpm), evidence of atrial-ventricular (AV) block on ECG of more than 1st degree.
History of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG).
Patients with a serum potassium value ≤ 3.5 mEq/L and/or serum glucose value ≥ 140 mg/dL.
Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females.
Evidence of posture and gait disturbances, or impairment of limb coordination due to any cause.
Patients taking oral corticosteroids in the last month prior to study entry.
Patients taking inhaled long-acting β2-agonists or anticholinergics in the last 48 hours.
Patients already taking inhaled corticosteroids (including nasal), sodium cromoglycate and nedocromil sodium, leukotriene antagonists, xanthyne derivatives, mucolytics, antitussives for whom the dose has been changed in the last month before study entry or is likely to change during the total study period.
History of hypersensitivity to sympathomimetic drugs.
Patients taking β-antagonists, tricyclic antidepressants or monoamine oxidase inhibitors (MAOI).
Pregnant or lactating females or females at risk of pregnancy, i.e. those not demonstrating adequate contraception (i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization). A pregnancy test is recommended - Patients with a post-bronchodilator FEV1 < 0.7 L and with a predicted normal FEV1 < 40%.
Patients requiring long-term oxygen therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742248

Locations

Italy
"Centro Dipartimentale di Fisiopatologia Respiratoria", University of Genoa
GENOVA, Italy, 16132

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Vito Brusasco "Centro Dipartimentale di Fisiopatologia Respiratoria", University of Genoa, Italy (Co-ordinating centre)

Giovanni Barisione "Unità Operativa di Medicina Preventiva e del Lavoro, Laboratorio di Fisiopatologia Respiratoria", S. Martino Hospital, Genoa, Italy

Giorgio Canonica "Clinica di Malattie dell'Apparato Respiratorio e Allergologia, Dipartimento di Medicina Interna", University of Genoa, Italy

Cardarelli Hospital

Roberto Dal Negro "Unità Operativa di Pneumologia", Hospital of Bussolengo (Verona), Italy

Leonardo Fabbri "Clinica di Malattie dell'Apparato Respiratorio", University of Modena, Italy

Carlo Mereu "Struttura complessa di Pneumologia", S. Corona Hospital, Pietra Ligure (Savona), Italy

Pierluigi Paggiaro "Servizio di Fisiopatologia Respiratoria, Dipartimento Cardiotoracico", University of Pisa, Italy

Giorgio Scano "Unità Operativa di Riabilitazione Respiratoria, Fondazione Don Carlo Gnocchi ONLUS", Pozzolatico (FI), Italy.

Investigators

Principal Investigator:	Giovanni Barisione, MD	"Unità Operativa di Medicina Preventiva e del Lavoro, Laboratorio di Fisiopatologia Respiratoria", S. Martino Hospital, Genoa, Italy
Principal Investigator:	Giorgio Canonica, MD	3) "Clinica di Malattie dell'Apparato Respiratorio e Allergologia, Dipartimento di Medicina Interna", University of Genoa, Italy
Principal Investigator:	Gennaro D'Amato, MD	'Unita' di Pneumologia e Allergologia, Dipartimento di Medicina Respiratoria', A. Cardarelli Hospital, Naples, Italy
Principal Investigator:	Roberto Dal Negro, MD	5) "Unità Operativa di Pneumologia", Hospital of Bussolengo (Verona), Italy
Principal Investigator:	Leonardo Fabbri, MD	"Clinica di Malattie dell'Apparato Respiratorio", University of Modena, Italy
Principal Investigator:	Carlo Mereu, MD	"Struttura complessa di Pneumologia", S. Corona Hospital, Pietra Ligure (Savona), Italy
Principal Investigator:	Pierluigi Paggiaro, MD	"Servizio di Fisiopatologia Respiratoria, Dipartimento Cardiotoracico", University of Pisa, Italy
Principal Investigator:	Giorgio Scano, MD	"Unità Operativa di Riabilitazione Respiratoria, Fondazione Don Carlo Gnocchi ONLUS", Pozzolatico (FI), Italy
Study Director:	Vito Brusasco, MD, PhD	"Centro Dipartimentale di Fisiopatologia Respiratoria", University of Genoa, Italy (Co-ordinating centre)

More Information

No publications provided

Responsible Party:	Chiesi Farmaceutici S.p.A. ( Guido Varoli, Clinical Project Manager )
Study ID Numbers:	DM PR 3301 002 03
Study First Received:	August 26, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00742248 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Chiesi Farmaceutici S.p.A.:

COPD

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions

Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010