AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 2NCT00640484

Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in 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 15 sites in United States.

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 confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours. 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
57 participants
Where
15 sitesUnited States
Study dates
Apr 2008to Oct 2008
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

  • Signed IRB approved Informed Consent form
  • Male or non-pregnant female, 40 -75 years old, inclusive
  • Current or past cigarette smoking history of at least 15 pack-years
  • Clinical diagnosis of COPD in accordance with recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
  • Patient meets following requirements after FEV1 albuterol reversibility test (i.e., 30 minutes after 200μg (metered dose) albuterol MDI):
  • FEV1/FVC < 70%
Show all 9Show fewer
  • 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, requirement must be met after retesting during run-in period, at least 24 hours prior to Period 1/Visit 1.

Who cannot join

  • History of asthma
  • Blood eosinophil count > 500/microliters
  • History of allergic rhinitis or atopy
  • COPD exacerbation or lower respiratory tract infection within 8 weeks prior to screening, or during run-in period, that resulted in use of an antibiotic, or oral or parenteral corticosteroids
  • Inhaled corticosteroid that has been initiated, or effective dose has been changed, within 4 weeks prior to screening or during run-in period
  • 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 Investigator's judgment, place patient at undue risk or potentially compromise study results or interpretation
Show all 31Show fewer
  • History of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
  • Lung cancer or history of lung cancer
  • Active cancer or history of cancer with < 5 years disease free survival time (with or without evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of skin is acceptable.
  • Serum potassium value ≤ 3.5 mEq/L or > 5.5mEq/L and/or fasting serum glucose value ≥ 140 mg/dL
  • Abnormal QTcF interval value in Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females)
  • Cor Pulmonale
  • Long term oxygen therapy, i.e., > 16 hours/24-hour period, every day, unless patient resides at elevation > 4000ft
  • Use of any of the following medications prior to Screening, without meeting 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 (other than those prescribed in the study): 6 hours
  • Theophylline and other xanthines: 1 week
  • Parenteral or oral corticosteroids: 1 month
  • Patient has taken any non-permitted medication
  • Patient has received live-attenuated virus vaccination within two weeks prior to screening or during run-in (inactivated Influenza vaccination is acceptable if given > 48 hours prior to Screening)
  • Known intolerance/hypersensitivity to β2-adrenergic agonists, propellant gases/excipients
  • Patient is pregnant or lactating female, or female at risk of pregnancy (i.e., not using adequate contraceptive method: surgical sterilization [e.g., bilateral tubal ligation], hormonal contraception [implantable, patch, oral], IUD, and double-barrier methods [any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap]).
  • Patient is mentally or legally incapacitated
  • Patient has participated in another investigational study within 30 days prior to screening
  • Abuse of 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 protocol outcome measurements

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Pulmonary Medicine and Critical Care

    Austell, Georgia, 30106

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • University Clinical Research - DeLand, LLC

    DeLand, Florida, 32720

  • Horizon Clinical Research Associates, PLLC

    Gilbert, Arizona, 85295

  • UCLA David Geffen School of Medicine

    Los Angeles, California, 90095

  • Commonwealth BioMedical Research

    Madisonville, Kentucky, 42431

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Sneeze, Wheeze & Itch Associates, LLC

    Normal, Illinois, 61761

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Pulmonary Associates, PA

    Phoenix, Arizona, 85006

  • Asthma Allergy Associates

    Portland, Oregon, 97213

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • University of Utah

    Salt Lake City, Utah, 84108

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Reichman Associates

    Sugar Land, Texas, 77074

Other trials in United States

About this study

Official title: Evaluation of the Effect of 2 Weeks Treatment With CHF 4226 pMDI 2µg and 4µg, Given Once Daily in the Morning, on 24-Hour FEV1 in Patients With COPD

The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.

Being tested
carmoterol (CHF 4226), placebo, salmeterol
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, TA2005

    carmoterol (CHF 4226) 2 μg once a day, in the morning

    (1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)

  • carmoterol (CHF 4226)Drug

    Also called CHF 4226, TA2005

    carmoterol (CHF 4226) 4 μg once a day, in the morning

    (1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)

  • placeboDrug

    placebo once a day, in the morning

    (1 puff of placebo pMDI + 1 puff of placebo pMDI)

  • salmeterolDrug

    Also called Serevent Diskus/Accuhaler

    Salmeterol 50 μg twice daily, in the morning and in the evening

    (1 blister of Serevent Diskus BID)

Study groups in NCT00640484
Study groupRoleWhat they receive
AExperimentalCHF 4226 (carmoterol) 2 μg once a day, in the morning
Receives: Drug: carmoterol (CHF 4226)
BExperimentalCHF 4226 (carmoterol) 4 μg once a day, in the morning
Receives: Drug: carmoterol (CHF 4226)
CPlacebo comparatorplacebo once a day, in the morning
Receives: Drug: placebo
DActive comparatorsalmeterol 50 μg twice daily, 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. FEV1 AUC0-24 standardized by time

    Measured: on Day 15 (after 14 days of dosing)

Secondary outcomes (4)

  1. FEV1(L)

    Measured: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods

  2. blood pressure

    Measured: at the beginning and end of each of the four 14-day treatment periods

  3. heart rate

    Measured: at the beginning and end of each of the four 14-day treatment periods

  4. FEV1 percent change

    Measured: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods

Timeline

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

  1. First posted21 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionOct 2008
  4. Study completionOct 2008

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
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00640484
Sponsor's protocol ID
CCD-0706-PR-0026
Status last verified
Aug 2010
First submitted
18 Mar 2008
Last updated
27 Aug 2010
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

  • 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

  • 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

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 15 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 9 inclusion and 31 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 AUC0-24 standardized by time (time frame: on Day 15 (after 14 days of dosing)). 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 NCT00640484, 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 27 Aug 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in