Chronic Obstructive Pulmonary DiseasePhase 3NCT00972140
Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 3 study testing Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Poland.
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. 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?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2005to Oct 2006
- Phase
- Phase 3
- 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
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 30Show fewer
- 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 β2-agonists during the 14-week study period.
- Short-acting β2-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 β2-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 β2-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.
- β-blockers in the week preceding the screening visit and during the 14-week study period.
- Intolerance to inhaled β2-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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Formoterol
- Keywords
- Patients with stable 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
Formoterol-HFA pMDI 12µg twice daily
FormoterolDrug
Also called Foradil
Formoterol-DPI 12 µg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Formoterol-HFA | Experimental | Formoterol-HFA pMDI 12µg twice daily Receives: Drug: Formoterol |
| Formoterol-DPI | Active comparator | Formoterol-DPI 12µg twice daily Receives: Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatment
Measured: Every 6 weeks
Secondary outcomes (1)
Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startAug 2005
- Primary completionApr 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iwona Graelewska Rzymowska, Prof, Principal investigator, Clinic Pneumology and Allergology Lodz Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972140
- Sponsor's protocol ID
- RA-PR-3301-011-04
- Status last verified
- Dec 2011
- First submitted
- 3 Sep 2009
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00972140
- Acronym / sponsor ID
- RA-PR-3301-011-04
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Patients with stable COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 4 Sep 2009 (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 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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formoterol-HFA | Experimental | Drug: FormoterolFormoterol-HFA pMDI 12µg twice daily |
| Formoterol-DPI | Active comparator | Drug: FormoterolFormoterol-DPI 12µg twice daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (30 listed)
- 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).
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: AtimosFormoterol-HFA pMDI 12µg twice daily | Drug | Formoterol-HFA |
| FormoterolAlso: ForadilFormoterol-DPI 12 µg twice daily | Drug | Formoterol-DPI |
Primary outcome
12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatment
Time frame: Every 6 weeks
1 secondary outcome
Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue
Time frame: Every 6 weeks
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 13 Dec 2011.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
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.
Iwona Graelewska Rzymowska, Prof principal investigator
Clinic Pneumology and Allergology Lodz Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Poland.
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 10 inclusion and 30 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 13 Dec 2011. 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 Poland. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatment (time frame: Every 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2011.