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

NCT00742248 | Completed Phase 2

• 1 other identifier: DM PR 3301 002 03
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• FEV1 area under the curve (AUC) standardized for time

  4 hours following the morning dose of study medication at the first visit of each treatment cycle

Secondary Outcomes (1)

• Clinical equivalence in terms of FEV1 area under the curve (AUC) standardized for time

  4 hours

Study Arms (3)

A

ACTIVE COMPARATOR

Formoterol pMDI

Drug: Formoterol; Drug: Placebo

B

ACTIVE COMPARATOR

Formoterol dry powder

Drug: Formoterol; Drug: Placebo

C

PLACEBO COMPARATOR

Placebo pMDI DPI

Drug: Placebo

Interventions

Formoterol DRUG

pMDI 12 mcg/dose 1 dose in the morning and 1 dose in the evening

Also known as: Atimos

A

Placebo DRUG

Placebo pMDI/DPI 1 dose in the morning and 1 dose in the evening

A; B; C

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead
• Vito Brusasco "Centro Dipartimentale di Fisiopatologia Respiratoria", University of Genoa, Italy (Co-ordinating centre): collaborator
• Giovanni Barisione "Unità Operativa di Medicina Preventiva e del Lavoro, Laboratorio di Fisiopatologia Respiratoria", S. Martino Hospital, Genoa, Italy: collaborator
• Universita degli Studi di Genova: collaborator
• Cardarelli Hospital: collaborator
• Roberto Dal Negro "Unità Operativa di Pneumologia", Hospital of Bussolengo (Verona), Italy: collaborator
• University of Modena and Reggio Emilia: collaborator
• Carlo Mereu "Struttura complessa di Pneumologia", S. Corona Hospital, Pietra Ligure (Savona), Italy: collaborator
• University of Pisa: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

"Centro Dipartimentale di Fisiopatologia Respiratoria", University of Genoa

Genova, 16132, Italy

Location

Related Publications (1)

• Brusasco V, Canonica GW, Dal Negro R, Scano G, Paggiaro P, Fabbri LM, Barisione G, D'Amato G, Varoli G, Baroffio M, Milanese M, Mereu C, Crimi E. Formoterol by pressurized metered-dose aerosol or dry powder on airway obstruction and lung hyperinflation in partially reversible COPD. J Aerosol Med Pulm Drug Deliv. 2011 Oct;24(5):235-43. doi: 10.1089/jamp.2010.0862. Epub 2011 Jun 20.

  PMID: 21689019 RESULT

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

• 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

  PRINCIPAL INVESTIGATOR

• Vito Brusasco, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: September 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

IT (1)