Asthma, Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT01365286
HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
A Phase 4 study testing Ivabradine (Procoralan) in people with Asthma, Chronic Obstructive Pulmonary Disease (COPD), run by Medical University of Lodz at 1 site in Poland.
Trial summary
The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Ivabradine (Procoralan)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- May 2009to Jan 2011
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented diagnosis of asthma or COPD in accordance with guidelines
- stable condition, defined as a disease without exacerbation for at least 1 month prior to study enrolment
- mean HR in holter ECG recording of ≥ 60 bpm
Who cannot join
- disease exacerbation in previous month
- inability to understand instructions on study procedures
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Lodz, Department of Pneumonology and Allergy
Lodz, 90-153
About this study
Official title: Heart Rate Lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.
Read the detailed description
In this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 COPD patients received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. HR in ECG holter monitoring, peak expiratory flow rate (PEFR), symptoms, rescue medication consumption and AEs were evaluated in both periods of treatment.
- Being tested
- Ivabradine (Procoralan), Placebo
- Keywords
- asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivabradine (Procoralan)Drug
Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)
PlaceboDrug
Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine-Placebo | Active comparator | Not described Receives: Drug: Ivabradine (Procoralan) |
| Placebo-Ivabradine | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Difference in mean heart rate during ivabradine and placebo treatment
Measured: Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day)
Secondary outcomes (4)
Peak expiratory flow rate (PEFR)
Difference in mean daily PEFR during ivabradine and placebo treatment
Measured: Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment
Symptoms
Difference in mean daily symptom score between ivabradine and placebo treatment
Measured: Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment
Rescue medication
Difference in mean daily rescue medication use between ivabradine and placebo treatment
Measured: Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment
Number of participants with adverse events (AEs)
Difference in number of participants with AEs between ivabradine and placebo treatment
Measured: Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Asthma, Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365286
- Sponsor's protocol ID
- Ivabradine2009-2011
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kannel WB, Kannel C, Paffenbarger RS Jr, Cupples LA. Heart rate and cardiovascular mortality: the Framingham Study. Am Heart J. 1987 Jun;113(6):1489-94. doi: 10.1016/0002-8703(87)90666-1.
PubMed 3591616Palatini P, Casiglia E, Pauletto P, Staessen J, Kaciroti N, Julius S. Relationship of tachycardia with high blood pressure and metabolic abnormalities: a study with mixture analysis in three populations. Hypertension. 1997 Nov;30(5):1267-73. doi: 10.1161/01.hyp.30.5.1267.
PubMed 9369286Hjalmarson A, Gilpin EA, Kjekshus J, Schieman G, Nicod P, Henning H, Ross J Jr. Influence of heart rate on mortality after acute myocardial infarction. Am J Cardiol. 1990 Mar 1;65(9):547-53. doi: 10.1016/0002-9149(90)91029-6.
PubMed 1968702Gillum RF, Makuc DM, Feldman JJ. Pulse rate, coronary heart disease, and death: the NHANES I Epidemiologic Follow-up Study. Am Heart J. 1991 Jan;121(1 Pt 1):172-7. doi: 10.1016/0002-8703(91)90970-s.
PubMed 1985358Fox K, Borer JS, Camm AJ, Danchin N, Ferrari R, Lopez Sendon JL, Steg PG, Tardif JC, Tavazzi L, Tendera M; Heart Rate Working Group. Resting heart rate in cardiovascular disease. J Am Coll Cardiol. 2007 Aug 28;50(9):823-30. doi: 10.1016/j.jacc.2007.04.079. Epub 2007 Aug 13.
PubMed 17719466Freemantle N, Cleland J, Young P, Mason J, Harrison J. beta Blockade after myocardial infarction: systematic review and meta regression analysis. BMJ. 1999 Jun 26;318(7200):1730-7. doi: 10.1136/bmj.318.7200.1730.
PubMed 10381708Frishman WH, Furberg CD, Friedewald WT. The use of beta-adrenergic blocking drugs in patients with myocardial infarction. Curr Probl Cardiol. 1984 Jun;9(3):1-50. doi: 10.1016/0146-2806(84)90015-x. No abstract available.
PubMed 6146495Gheorghiade M, Goldstein S. Beta-blockers in the post-myocardial infarction patient. Circulation. 2002 Jul 23;106(4):394-8. doi: 10.1161/01.cir.0000019582.39797.ef. No abstract available.
PubMed 12135934Farrell MH, Foody JM, Krumholz HM. beta-Blockers in heart failure: clinical applications. JAMA. 2002 Feb 20;287(7):890-7. doi: 10.1001/jama.287.7.890.
PubMed 11851583Fihn SD, Williams SV, Daley J, Gibbons RJ; American College of Cardiology; American Heart Association; American College of Physicians-American Society of Internal Medicine. Guidelines for the management of patients with chronic stable angina: treatment. Ann Intern Med. 2001 Oct 16;135(8 Pt 1):616-32. doi: 10.7326/0003-4819-135-8_part_1-200110160-00014.
PubMed 11601935Benson MK, Berrill WT, Cruickshank JM, Sterling GS. A comparison of four beta-adrenoceptor antagonists in patients with asthma. Br J Clin Pharmacol. 1978 May;5(5):415-9. doi: 10.1111/j.1365-2125.1978.tb01647.x.
PubMed 26371Schwartz S, Davies S, Juers JA. Life-threatening cold and exercise-induced asthma potentiated by administration of propranolol. Chest. 1980 Jul;78(1):100-1. doi: 10.1378/chest.78.1.100.
PubMed 7471827Williams IP, Millard FJ. Severe asthma after inadvertent ingestion of oxprenolol. Thorax. 1980 Feb;35(2):160. doi: 10.1136/thx.35.2.160. No abstract available.
PubMed 7376124Chang CL, Mills GD, McLachlan JD, Karalus NC, Hancox RJ. Cardio-selective and non-selective beta-blockers in chronic obstructive pulmonary disease: effects on bronchodilator response and exercise. Intern Med J. 2010 Mar;40(3):193-200. doi: 10.1111/j.1445-5994.2009.01943.x. Epub 2009 Mar 10.
PubMed 19383058DiFrancesco D, Camm JA. Heart rate lowering by specific and selective I(f) current inhibition with ivabradine: a new therapeutic perspective in cardiovascular disease. Drugs. 2004;64(16):1757-65. doi: 10.2165/00003495-200464160-00003.
PubMed 15301560
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
- ClinicalTrials.gov ID
- NCT01365286
- Acronym / sponsor ID
- Ivabradine2009-2011
- Keywords
- asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Jun 2011 (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 investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.
Detailed description
In this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 COPD patients received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. HR in ECG holter monitoring, peak expiratory flow rate (PEFR), symptoms, rescue medication consumption and AEs were evaluated in both periods of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine-Placebo | Active comparator | Drug: Ivabradine (Procoralan) |
| Placebo-Ivabradine | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- documented diagnosis of asthma or COPD in accordance with guidelines
- stable condition, defined as a disease without exacerbation for at least 1 month prior to study enrolment
- mean HR in holter ECG recording of ≥ 60 bpm
Key exclusion criteria (2 listed)
- disease exacerbation in previous month
- inability to understand instructions on study procedures
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 |
|---|---|---|
| Ivabradine (Procoralan)Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo) | Drug | Ivabradine-Placebo |
| PlaceboPlacebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine) | Drug | Placebo-Ivabradine |
Primary outcome
Heart rate
Time frame: Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day)
Difference in mean heart rate during ivabradine and placebo treatment
4 secondary outcomes
Peak expiratory flow rate (PEFR)
Time frame: Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment
Symptoms
Time frame: Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment
Rescue medication
Time frame: Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment
Number of participants with adverse events (AEs)
Time frame: Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment)
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 12 Jun 2012.
- Background: PubMed 3591616Kannel WB, Kannel C, Paffenbarger RS Jr, Cupples LA. Heart rate and cardiovascular mortality: the Framingham Study. Am Heart J. 1987 Jun;113(6):1489-94. doi: 10.1016/0002-8703(87)90666-1.
- Background: PubMed 9369286Palatini P, Casiglia E, Pauletto P, Staessen J, Kaciroti N, Julius S. Relationship of tachycardia with high blood pressure and metabolic abnormalities: a study with mixture analysis in three populations. Hypertension. 1997 Nov;30(5):1267-73. doi: 10.1161/01.hyp.30.5.1267.
- Background: PubMed 1968702Hjalmarson A, Gilpin EA, Kjekshus J, Schieman G, Nicod P, Henning H, Ross J Jr. Influence of heart rate on mortality after acute myocardial infarction. Am J Cardiol. 1990 Mar 1;65(9):547-53. doi: 10.1016/0002-9149(90)91029-6.
- Background: PubMed 1985358Gillum RF, Makuc DM, Feldman JJ. Pulse rate, coronary heart disease, and death: the NHANES I Epidemiologic Follow-up Study. Am Heart J. 1991 Jan;121(1 Pt 1):172-7. doi: 10.1016/0002-8703(91)90970-s.
- Background: PubMed 17719466Fox K, Borer JS, Camm AJ, Danchin N, Ferrari R, Lopez Sendon JL, Steg PG, Tardif JC, Tavazzi L, Tendera M; Heart Rate Working Group. Resting heart rate in cardiovascular disease. J Am Coll Cardiol. 2007 Aug 28;50(9):823-30. doi: 10.1016/j.jacc.2007.04.079. Epub 2007 Aug 13.
- Background: PubMed 10381708Freemantle N, Cleland J, Young P, Mason J, Harrison J. beta Blockade after myocardial infarction: systematic review and meta regression analysis. BMJ. 1999 Jun 26;318(7200):1730-7. doi: 10.1136/bmj.318.7200.1730.
- Background: PubMed 6146495Frishman WH, Furberg CD, Friedewald WT. The use of beta-adrenergic blocking drugs in patients with myocardial infarction. Curr Probl Cardiol. 1984 Jun;9(3):1-50. doi: 10.1016/0146-2806(84)90015-x. No abstract available.
- Background: PubMed 12135934Gheorghiade M, Goldstein S. Beta-blockers in the post-myocardial infarction patient. Circulation. 2002 Jul 23;106(4):394-8. doi: 10.1161/01.cir.0000019582.39797.ef. No abstract available.
- Background: PubMed 11851583Farrell MH, Foody JM, Krumholz HM. beta-Blockers in heart failure: clinical applications. JAMA. 2002 Feb 20;287(7):890-7. doi: 10.1001/jama.287.7.890.
- Background: PubMed 11601935Fihn SD, Williams SV, Daley J, Gibbons RJ; American College of Cardiology; American Heart Association; American College of Physicians-American Society of Internal Medicine. Guidelines for the management of patients with chronic stable angina: treatment. Ann Intern Med. 2001 Oct 16;135(8 Pt 1):616-32. doi: 10.7326/0003-4819-135-8_part_1-200110160-00014.
- Background: PubMed 26371Benson MK, Berrill WT, Cruickshank JM, Sterling GS. A comparison of four beta-adrenoceptor antagonists in patients with asthma. Br J Clin Pharmacol. 1978 May;5(5):415-9. doi: 10.1111/j.1365-2125.1978.tb01647.x.
- Background: PubMed 7471827Schwartz S, Davies S, Juers JA. Life-threatening cold and exercise-induced asthma potentiated by administration of propranolol. Chest. 1980 Jul;78(1):100-1. doi: 10.1378/chest.78.1.100.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine (Procoralan) in people with Asthma, Chronic Obstructive Pulmonary Disease (COPD), run by Medical University of Lodz 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 3 inclusion and 2 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 12 Jun 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Heart rate (time frame: Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day)). 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 NCT01365286, which also lists 36 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 12 Jun 2012.