Chronic Obstructive Pulmonary DiseasePhase 2NCT00782535
Safety and Efficacy Study of Treatment With Single Doses of CHF 4226 pMDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing CHF 4226 pMDI in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 5 sites in United States.
Trial summary
The purpose of this study is to characterize the dose-response profile of peak and trough FEV1 after single dose administrations of carmoterol in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- CHF 4226 pMDI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2008to Mar 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed an IRB approved Informed Consent form and the written informed consent was obtained prior to any study-related procedure(s)
- Patient is a male or non-pregnant female, 40 -75 years old, inclusive
- Patient has a current or past cigarette smoking history of at least 15 pack-years
- Patient has a clinical diagnosis of COPD in accordance with the recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- Patient meets the following requirements after an FEV1 albuterol reversibility test (i.e., 30 minutes following 400µg (metered dose) albuterol MDI):
- FEV1/FVC < 70%
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- FEV1 is at least 0.9L
- FEV1 30% - 80%, inclusive, of patient's predicted normal value
- ∆FEV1 > 5% of pre-albuterol value
- If ∆FEV1 </= 5% of pre-albuterol value, then this requirement must be met after retesting during the run-in period, at least 24 hours prior to Visit 2.
Who cannot join
- Patient has a history of asthma
- Patient has a blood eosinophil count > 500/µL
- Patient has a history of allergic rhinitis or atopy
- Patient had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids
- Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period
- Patient has an uncontrolled cardiovascular (e.g., uncontrolled hypertension), respiratory, hematologic, immunologic, renal, neurologic, hepatic, endocrine (e.g., uncontrolled diabetes mellitus) or other disease, or any condition that might, in the judgment of the Investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
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- Patient has clinically significant abnormal routine hematology (e.g., anemia) and/or clinical chemistry value(s).
- Patient has a history of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
- Patient has lung cancer or a history of lung cancer
- Patient has active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
- Patient has a serum potassium value ≤ 3.5 mEq/L or > 5.5mEq/L and/or a fasting serum glucose value ≥ 140 mg/dL
- Patient has an abnormal QTcF interval value in the Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females)
- Patient has developed Cor Pulmonale
- Patient is receiving long term oxygen therapy, i.e., > 16 hours/24-hour period, every day, unless residing at an elevation > 4000ft
- Patient has used any of the following medications prior to Screening and has not met the specified minimum washout period:
- Long acting anti-cholinergic agent (i.e., tiotropium): 7 days
- Short acting anti-cholinergics: 8 hours
- Fixed combinations of β2-agonists and inhaled corticosteroids: 48 hours
- Fixed combinations of an anti-cholinergic and short acting β2-agonist: 8 hours
- Long-acting β2-agonists: 48 hours
- Short acting β2-agonists: 6 hours
- Theophylline and other xanthines: 1 week
- Parenteral or oral corticosteroids: 1 month
- Patient has taken any non-permitted medication
- Patient has received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in (inactivated Influenza vaccination is acceptable provided it is not administered within 48 hours prior to Screening)
- Patient has a known intolerance/hypersensitivity to β2-adrenergic agonists, propellant gases/excipients
- Patient is pregnant or lactating female, or female physiologically capable of becoming pregnant UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL OR are using one or more of the following acceptable methods of contraception:
- surgical sterilization (e.g., bilateral tubal ligation, hysterectomy)
- hormonal contraception (implantable, patch, oral)
- double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
- Patient is male and does not agree to use a medically acceptable contraceptive (abstain from sexual intercourse, or use a condom with spermicide), or has not had a vasectomy at least 6 months prior to study participation, unless their sexual partner is not of child-bearing potential
- Patient is mentally or legally incapacitated
- Patient has participated in another investigational study within 30 days prior to screening
- Patient abuses alcohol or other substances
- Patient does not maintain regular day/night, waking/sleeping cycles (e.g., night shift worker)
- Patient is potentially non-compliant or unable to perform required outcome measurements of the protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New Horizons Clinical Research Center
Cincinnati, Ohio, 45242
University Clinical Research DeLand, LLC
DeLand, Florida, 32720
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: EVALUATION OF THE SAFETY AND EFFICACY OF TREATMENT WITH SINGLE DOSES OF CHF 4226 pMDI IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE A Multicenter, Randomized, Double-Blind,Placebo-Controlled, 5-Way Crossover Study
The purpose of this study is to characterize the dose-response profile of peak and trough FEV1 after single dose administrations of carmoterol in patients with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- CHF 4226 pMDI, Placebo
- 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.
CHF 4226 pMDIDrug
Inhaled solution, single therapeutic dose
CHF 4226 pMDIDrug
Inhaled solution, single supratherapeutic dose
PlaceboDrug
Inhaled solution, single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single therapeutic dose of CHF 4226 pMDI Receives: Drug: CHF 4226 pMDI |
| Treatment B | Experimental | Single therapeutic dose of CHF 4226 pMDI Receives: Drug: CHF 4226 pMDI |
| Treatment C | Experimental | Single supratherapeutic dose of CHF 4226 pMDI Receives: Drug: CHF 4226 pMDI |
| Treatment D | Experimental | Single supratherapeutic dose of CHF 4226 pMDI Receives: Drug: CHF 4226 pMDI |
| Treatment E | Placebo comparator | Single dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Measured: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period
Secondary outcomes (5)
serum potassium
Measured: pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period
serum glucose
Measured: pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period
plasma concentrations of CHF 4226
Measured: pre dose and 15 minutes and 2 hours post dose for each treatment period
urinary excretion of CHF 4226
Measured: pre dose and 0-24 hrs post dose for each treatment period
FVC
Measured: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionMar 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory M Gottschlich, MD, Principal investigator, New Horizons Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782535
- Sponsor's protocol ID
- CCD-0810-PR-0001
- Status last verified
- Oct 2019
- First submitted
- 29 Oct 2008
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE SAFETY AND EFFICACY OF TREATMENT WITH SINGLE DOSES OF CHF 4226 pMDI IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE A Multicenter, Randomized, Double-Blind,Placebo-Controlled, 5-Way Crossover Study
- ClinicalTrials.gov ID
- NCT00782535
- Acronym / sponsor ID
- CCD-0810-PR-0001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 31 Oct 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 characterize the dose-response profile of peak and trough FEV1 after single dose administrations of carmoterol in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: CHF 4226 pMDISingle therapeutic dose of CHF 4226 pMDI |
| Treatment B | Experimental | Drug: CHF 4226 pMDISingle therapeutic dose of CHF 4226 pMDI |
| Treatment C | Experimental | Drug: CHF 4226 pMDISingle supratherapeutic dose of CHF 4226 pMDI |
| Treatment D | Experimental | Drug: CHF 4226 pMDISingle supratherapeutic dose of CHF 4226 pMDI |
| Treatment E | Placebo comparator | Drug: PlaceboSingle dose of placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient has signed an IRB approved Informed Consent form and the written informed consent was obtained prior to any study-related procedure(s)
- Patient is a male or non-pregnant female, 40 -75 years old, inclusive
- Patient has a current or past cigarette smoking history of at least 15 pack-years
- Patient has a clinical diagnosis of COPD in accordance with the recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- Patient meets the following requirements after an FEV1 albuterol reversibility test (i.e., 30 minutes following 400µg (metered dose) albuterol MDI):
Key exclusion criteria (36 listed)
- Patient has a history of asthma
- Patient has a blood eosinophil count > 500/µL
- Patient has a history of allergic rhinitis or atopy
- Patient had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids
- Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period
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 |
|---|---|---|
| CHF 4226 pMDIInhaled solution, single therapeutic dose | Drug | Treatment A, Treatment B |
| CHF 4226 pMDIInhaled solution, single supratherapeutic dose | Drug | Treatment C, Treatment D |
| PlaceboInhaled solution, single dose of placebo | Drug | Treatment E |
Primary outcome
FEV1
Time frame: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period
5 secondary outcomes
serum potassium
Time frame: pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period
serum glucose
Time frame: pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period
plasma concentrations of CHF 4226
Time frame: pre dose and 15 minutes and 2 hours post dose for each treatment period
urinary excretion of CHF 4226
Time frame: pre dose and 0-24 hrs post dose for each treatment period
FVC
Time frame: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period
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 6 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Gregory M Gottschlich, MD principal investigator
New Horizons Clinical Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF 4226 pMDI in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 5 sites in United States.
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 36 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 (time frame: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period). 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 6 Nov 2019.