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Chronic Obstructive Pulmonary DiseasePhase 2NCT00605891

Dose Finding Study of CHF 4226 for Treating Patients With COPD

A Phase 2 study testing carmoterol (CHF 4226) and salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 50 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be further developed for the treatment of 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?
carmoterol (CHF 4226) and salmeterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
278 participants
Where
50 sitesin 6 countries
Study dates
Oct 2006to Jun 2007
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-/Ethics Committee-approved Informed Consent form
  • Patient is a male or non-pregnant female between the ages of 40 - 75 years, inclusive
  • Patient has a current or past 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 200 mcg (metered dose) albuterol/salbutamol pMDI):
  • FEV1 is at least 0.9L
Show all 10Show fewer
  • FEV1 of 40% - 70%, inclusive, of patient's predicted normal value
  • Change in FEV1 > 4% of patient's predicted normal value
  • If change in FEV1 < 4% of patient's predicted normal value, then this requirement must be met after retesting during the run-in period, at least 24 hours prior to Day -1
  • FEV1/FVC < 70%

Who cannot join

  • Patient has a history of asthma, allergic rhinitis, or atopy
  • Patient has a blood eosinophil count > 500/microliter
  • 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
  • Patient has a history of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
Show all 19Show fewer
  • Patient has a concomitant disease of poor prognosis (e.g., cancer)
  • 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 QTc Fridericia 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
  • Patient has a known intolerance/hypersensitivity to Beta2-adrenergic agonists, propellant gases/excipients
  • Patient is receiving treatment with a tricyclic antidepressant or a monoamine oxidase inhibitor (MAOI)
  • Patient has received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in
  • Patient is pregnant or lactating female, or female at risk of pregnancy (i.e., not using an adequate contraceptive method)
  • 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 is potentially non-compliant or unable to perform required outcome measurements of the protocol

Trial locations and contacts

50 sites in 6 countries.

50 sites in 6 countries

United States24 sites

  • Amarillo Center for Clinical Research, Ltd.

    Amarillo, Texas, 79124

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • ClinSite, LLC

    Ann Arbor, Michigan, 48106

  • ClinSite

    Canton, Michigan, 48187

  • Delaware Valley Clinical Research

    Cherry Hill, New Jersey, 08003

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • University Clinical Research - DeLand, LLC

    DeLand, Florida, 32720

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • ABM Research Center

    Fresno, California, 93720

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Breath of Life Research Institute

    Katy, Texas, 77450

  • University of Wisconsin-Allergy/Asthma

    Madison, Wisconsin, 53792

  • Clinical Research Institute of Southern Oregon PC

    Medford, Oregon, 97504

  • Pulmonary Consultants - Research Department

    Medford, Oregon, 97504

  • Edward Hospital and Helath Services, Center for Clinical Trials

    Naperville, Illinois, 60540

  • Lowcountry Lung and Critical Care, PA

    North Charleston, South Carolina, 29406

  • UCSD - Clinical Trials Center

    San Diego, California, 92103

  • Institute of Healthcare Assessment Inc.

    San Diego, California, 92120

  • Carolina Pharmaceutical Research

    Statesville, North Carolina, 28625

  • Toledo Center for Clinical Research

    Sylvania, Ohio, 43560

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • The University of Texas Health Center at Tyler

    Tyler, Texas, 75708

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

Other trials in United States

Czechia7 sites

  • Ordinace pro nemoci dychaciho ustroji

    Beroun, 266 01

  • OTRAN

    Kutná Hora, 284 01

  • Plicni a alergologicka ambulance

    Kutná Hora, 284 01

  • Pneumolog, internista

    Lovosice, 310 02

  • Nemocnice Na Homolce Plicni ambulance

    Prague, 15030

  • Plicni ambulance

    Praha 3 - Zizkov, 130 00

  • Plicni ambulance Rokycany

    Rokycany, 337 01

Other trials in Czechia

Germany7 sites

  • Medars GmbH

    Berlin, 14057

  • Lungenzentrum Geesthacht

    Geesthacht, 21502

  • Pneumologisches Forschungsinstitut GmbH

    Großhansdorf, 22927

  • Pneumologisches Forschungsinstitut Niederlassung Hamburg

    Hamburg, 20535

  • Robert-Koch-Klinik

    Leipzig, 04207

  • SMO, MD GmbH

    Magdeburg, 39112

  • IFG GmbH

    Rüdersdorf, 15565

Other trials in Germany

Romania6 sites

  • Spitalul Clinic Judetean de Urgenta Brasov

    Brasov, 500326

  • Spitalul de Urgenta "Prof. Dr. Dimitrie Gerota"

    Bucharest, 010457

  • Spitalul Clinic de Urgenta Militar Central "Davila"

    Bucharest, 010825

  • Spitalul Clinic "Sf. Maria"

    Bucharest, 011172

  • Institutul National de Pneumoftisiologie "M. Nasta"

    Bucharest, 050159

  • Spitalul de Pneumoftiziologie Constanta

    Constanța, 900002

Other trials in Romania

Poland4 sites

  • Medcare Specjalistyczna Opieka Medyczna NZOZ

    Gdansk, 80-433

  • NZOZ Non-nocere

    Gdansk, 80-847

  • Klinika Pulmonologii i Alergologii

    Lodz, 90-153

  • SPZOZ w Proszowicach Oddzial Chorob Pluc

    Proszowice, 32-100

Other trials in Poland

South Africa2 sites

  • Tiervlei Trial Center, Karl Bremer Hospital

    Bellville, 7530

  • UCT Lung Institute

    Mowbray, Cape Town, 7700

Other trials in South Africa

About this study

Official title: A Randomized, Controlled,14-Treatment Day, Multicenter Study to Determine the Optimal Efficacious and Safe Dose of CHF 4226 in a Metered Dose Inhaler in Treating Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be further developed for the treatment of patients with COPD.

Being tested
carmoterol (CHF 4226), salmeterol, 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.

  • carmoterol (CHF 4226)Drug

    Also called CHF 4226

    carmoterol pMDI 2.0 μg once a day, in the morning

    (1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)

  • carmoterol (CHF 4226)Drug

    Also called CHF 4226

    carmoterol pMDI 1.0 μg once a day, in the morning

    (1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))

  • carmoterol (CHF 4226)Drug

    Also called CHF 4226

    carmoterol pMDI 4.0 μg once a day, in the morning

    (1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)

  • salmeterolDrug

    Also called Serevent® Diskus®/Accuhaler®

    Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)

  • placeboDrug

    Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)

Study groups in NCT00605891
Study groupRoleWhat they receive
AExperimentalcarmoterol (CHF 4226) 1.0 μg once a day, in the morning
Receives: Drug: carmoterol (CHF 4226)
BExperimentalcarmoterol (CHF 4226) 2.0 μg once a day, in the morning
Receives: Drug: carmoterol (CHF 4226)
CExperimentalcarmoterol (CHF 4226) 4.0 μg once a day, in the morning
Receives: Drug: carmoterol (CHF 4226)
DPlacebo comparatorPlacebo once a day, in the morning
Receives: Drug: placebo
EActive comparatorSalmeterol 50 μg BID, in the morning and in the evening
Receives: Drug: salmeterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in FEV1

    Measured: Day 1 to Day 14 (+3 days)

Secondary outcomes (5)

  1. FEV1

    Measured: 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3)

  2. ECG/QTc

    Measured: pre dose and post dose at 30' on Days 1, 2 and 14 (+3)

  3. Fasting serum potassium

    Measured: pre dose and post dose at 30' on Days 1, 2 and 14 (+3)

  4. Fasting glucose

    Measured: pre dose and post dose at 30' on Days 1, 2 and 14 (+3)

  5. Change in FEV1

    Measured: 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2008 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605891
Sponsor's protocol ID
US/PR/033009/001/05
Other IDs
EudraCT Number: 2006-000531-10
Status last verified
Apr 2017
First submitted
18 Jan 2008
Last updated
11 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Matera MG, Cazzola M. ultra-long-acting beta2-adrenoceptor agonists: an emerging therapeutic option for asthma and COPD? Drugs. 2007;67(4):503-15. doi: 10.2165/00003495-200767040-00002.

    PubMed 17352511

  • Cazzola M, Matera MG, Lotvall J. Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease. Expert Opin Investig Drugs. 2005 Jul;14(7):775-83. doi: 10.1517/13543784.14.7.775.

    PubMed 16022567

  • Matsukawa M, Takeda K, Shima H, Tagawa K, Banno K, Sato T. Enzyme-linked immunosorbent assay for TA-2005-glucuronide in human plasma. J Pharm Biomed Anal. 1998 Jun;17(2):245-54. doi: 10.1016/s0731-7085(97)00186-6.

    PubMed 9638577

  • Kikkawa H, Isogaya M, Nagao T, Kurose H. The role of the seventh transmembrane region in high affinity binding of a beta 2-selective agonist TA-2005. Mol Pharmacol. 1998 Jan;53(1):128-34. doi: 10.1124/mol.53.1.128.

    PubMed 9443940

  • Rossoni G, Manfredi B, Razzetti R, Civelli M, Bongrani S, Berti F. Positive interaction of the beta2-agonist CHF 4226.01 with budesonide in the control of bronchoconstriction induced by acetaldehyde in the guinea-pigs. Br J Pharmacol. 2005 Feb;144(3):422-9. doi: 10.1038/sj.bjp.0706096.

    PubMed 15655502

  • Rossoni G, Manfredi B, Razzetti R, Civelli M, Berti F. Positive interaction of the novel beta2-agonist carmoterol and tiotropium bromide in the control of airway changes induced by different challenges in guinea-pigs. Pulm Pharmacol Ther. 2007;20(3):250-7. doi: 10.1016/j.pupt.2006.01.004. Epub 2006 Mar 14.

    PubMed 16533614

  • Voss HP, Shukrula S, Wu TS, Donnell D, Bast A. A functional beta-2 adrenoceptor-mediated chronotropic response in isolated guinea pig heart tissue: selectivity of the potent beta-2 adrenoceptor agonist TA 2005. J Pharmacol Exp Ther. 1994 Oct;271(1):386-9.

    PubMed 7965739

  • Kikkawa H, Kanno K, Ikezawa K. TA-2005, a novel, long-acting, and selective beta 2-adrenoceptor agonist: characterization of its in vivo bronchodilating action in guinea pigs and cats in comparison with other beta 2-agonists. Biol Pharm Bull. 1994 Aug;17(8):1047-52. doi: 10.1248/bpb.17.1047.

    PubMed 7820105

  • Voss HP, Donnell D, Bast A. Atypical molecular pharmacology of a new long-acting beta 2-adrenoceptor agonist, TA 2005. Eur J Pharmacol. 1992 Dec 1;227(4):403-9. doi: 10.1016/0922-4106(92)90158-r.

    PubMed 1359974

  • Kikkawa H, Naito K, Ikezawa K. Tracheal relaxing effects and beta 2-selectivity of TA-2005, a newly developed bronchodilating agent, in isolated guinea pig tissues. Jpn J Pharmacol. 1991 Oct;57(2):175-85. doi: 10.1254/jjp.57.175.

    PubMed 1687479

  • Spadari-Bartfisch RC, Santos IN, Vanderlei LC, Marcondes FK. Pharmacological evidence for beta2-adrenoceptor in right atria from stressed female rats. Can J Physiol Pharmacol. 1999 Jun;77(6):432-40.

    PubMed 10537229

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carmoterol (CHF 4226) and salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 50 sites in 6 countries.

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 19 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Czechia, Germany, Romania, Poland and 1 more country. 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?

Change in FEV1 (time frame: Day 1 to Day 14 (+3 days)). 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 NCT00605891, which also lists 11 linked publications.

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 11 Apr 2017.

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