Chronic Obstructive Pulmonary DiseasePhase 2NCT00742248
Formoterol Via pMDI HFA-134a Propellant or DPI in Partially Reversible Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Formoterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
"Centro Dipartimentale di Fisiopatologia Respiratoria", University of Genoa
Genova, 16132
About this 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
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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Formoterol, Placebo
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormoterolDrug
Also called Atimos
pMDI 12 mcg/dose 1 dose in the morning and 1 dose in the evening
FormoterolDrug
Also called Foradil
DPI 12 mcg/dose 1 dose in the morning and 1 dose in the evening
PlaceboDrug
Placebo pMDI/DPI 1 dose in the morning and 1 dose in the evening
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Formoterol pMDI Receives: Drug: Formoterol; Drug: Placebo |
| B | Active comparator | Formoterol dry powder Receives: Drug: Formoterol; Drug: Placebo |
| C | Placebo comparator | Placebo pMDI DPI Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 area under the curve (AUC) standardized for time
Measured: 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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startSep 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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, Universita degli Studi di Genova, Cardarelli Hospital, Roberto Dal Negro "Unità Operativa di Pneumologia", Hospital of Bussolengo (Verona), Italy, University of Modena and Reggio Emilia, Carlo Mereu "Struttura complessa di Pneumologia", S. Corona Hospital, Pietra Ligure (Savona), Italy, University of Pisa, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Giovanni Barisione, MD, Principal investigator, "Unità Operativa di Medicina Preventiva e del Lavoro, Laboratorio di Fisiopatologia Respiratoria", S. Martino Hospital, Genoa, ItalyGiorgio Canonica, MD, Principal investigator, 3) "Clinica di Malattie dell'Apparato Respiratorio e Allergologia, Dipartimento di Medicina Interna", University of Genoa, ItalyGennaro D'Amato, MD, Principal investigator, 'Unita' di Pneumologia e Allergologia, Dipartimento di Medicina Respiratoria', A. Cardarelli Hospital, Naples, ItalyRoberto Dal Negro, MD, Principal investigator, 5) "Unità Operativa di Pneumologia", Hospital of Bussolengo (Verona), ItalyLeonardo Fabbri, MD, Principal investigator, "Clinica di Malattie dell'Apparato Respiratorio", University of Modena, ItalyCarlo Mereu, MD, Principal investigator, "Struttura complessa di Pneumologia", S. Corona Hospital, Pietra Ligure (Savona), ItalyPierluigi Paggiaro, MD, Principal investigator, "Servizio di Fisiopatologia Respiratoria, Dipartimento Cardiotoracico", University of Pisa, ItalyGiorgio Scano, MD, Principal investigator, "Unità Operativa di Riabilitazione Respiratoria, Fondazione Don Carlo Gnocchi ONLUS", Pozzolatico (FI), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742248
- Sponsor's protocol ID
- DM PR 3301 002 03
- Status last verified
- Jul 2020
- First submitted
- 26 Aug 2008
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21689019
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00742248
- Acronym / sponsor ID
- DM PR 3301 002 03
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- 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, Universita degli Studi di Genova, Cardarelli Hospital, Roberto Dal Negro "Unità Operativa di Pneumologia", Hospital of Bussolengo (Verona), Italy, University of Modena and Reggio Emilia, Carlo Mereu "Struttura complessa di Pneumologia", S. Corona Hospital, Pietra Ligure (Savona), Italy, University of Pisa, Fondazione Don Carlo Gnocchi ETS
- Study start
- Sep 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Formoterol, Drug: PlaceboFormoterol pMDI |
| B | Active comparator | Drug: Formoterol, Drug: PlaceboFormoterol dry powder |
| C | Placebo comparator | Drug: PlaceboPlacebo pMDI DPI |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FormoterolAlso: AtimospMDI 12 mcg/dose 1 dose in the morning and 1 dose in the evening | Drug | A |
| FormoterolAlso: ForadilDPI 12 mcg/dose 1 dose in the morning and 1 dose in the evening | Drug | A, B |
| PlaceboPlacebo pMDI/DPI 1 dose in the morning and 1 dose in the evening | Drug | A, B, C |
Primary outcome
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
1 secondary outcome
Clinical equivalence in terms of FEV1 area under the curve (AUC) standardized for time
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Results publication: PubMed 21689019Brusasco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Barisione, MD principal investigator
"Unità Operativa di Medicina Preventiva e del Lavoro, Laboratorio di Fisiopatologia Respiratoria", S. Martino Hospital, Genoa, Italy
Giorgio Canonica, MD principal investigator
3) "Clinica di Malattie dell'Apparato Respiratorio e Allergologia, Dipartimento di Medicina Interna", University of Genoa, Italy
Gennaro D'Amato, MD principal investigator
'Unita' di Pneumologia e Allergologia, Dipartimento di Medicina Respiratoria', A. Cardarelli Hospital, Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.