Pulmonary Disease, Chronic ObstructivePhase 3NCT02194205

Comparison of Safety and Efficacy of COMBIVENT HFA to COMBIVENT (CFC) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing COMBIVENT HFA and COMBIVENT CFC in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

To compare the long-term (one-year) bronchodilator efficacy and safety of COMBIVENT hydrofluoroalkane (HFA) Inhalation Aerosol to COMBIVENT chlorofluorocarbon (CFC) Inhalation Aerosol and Placebo formulations of each in patients with COPD. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: COMBIVENT HFA and COMBIVENT CFC
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: No sites listed yet
Study dates: Oct 2000to Jun 2001
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

All patients must have a diagnosis of COPD
Male or female patients 40 years of age or older
Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
Patients must be able to perform technically satisfactory pulmonary function tests
Patients must be able to be trained in the proper use of a metered dose inhalator (MDI)
All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications
Patients must be on at least one regular aerosol bronchodilator for control of their COPD symptoms and have symptoms of bronchospasm (wheeze or shortness of breath) present OR Patients must be on at least two classes of prescribed bronchodilators on a regular basis for control of their COPD symptoms for the three month period immediately preceding the screening visit.

Who cannot join

Patients with significant disease other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
All patients with a serum aspartate amino transferase (ASAT/SGOT) > 80 IU/L, serum alanine amino transferase (ALAT/SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these patients.
Patients who have a total bood eosinophil count >= 600 mm**3. A repeat eosinophil count will not be conducted in these patients
Patients with a recent history (i.e. one year or less) of myocardial infarction
Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy

Show all 27Show fewer

Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
Patients who have undergone thoracotomy with pulmonary resection. Patients wth a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
Patients with a history of asthma, allergic rhinitis or atopy.
Patients with a history of or active alcohol or drug abuse
Patients with known active tuberculosis
Patients with an upper respiratory tract infection or COPD exacerbation in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
Patients with known narrow-angle glaucoma
Patients with current significant psychiatric disorders
Patients with regular use of daytime oxygen therapy
Patients who are being treated with beta-blocker medications, monoamine oxidase (MAO) inhibitors or tricyclic antidepressants
Patients who are being treated with cromolyn sodium or nedocromil sodium
Patients who are being treated with antihistamines
Patients using oral corticosteroid medication at unstable doses or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
Patients who have been treated with oral beta-adrenergics or long-acting beta-adrenergics in the two weeks prior to the Screening Visit or during the baseline period
Patients who have had changes in their therapeutic plan within the last six weeks prior to the Screening Visit or during the baseline period, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial
Pregnant of nursing women or woman of childbearing potential not using a medically approved means of contraception
Patients with known hypersensitivity to anticholinergic or beta-agonist drugs or any other component of either COMBIVENT formulation
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening visit
Previous participation in this study

About this study

Official title: A One-year Randomized, Double-blind, Placebo and Active-controlled Parallel Design Safety and Efficacy Comparison of COMBIVENT HFA Inhalation Aerosol to COMBIVENT (CFC) Inhalation Aerosol in Patients With COPD

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: COMBIVENT HFA, Placebo HFA, COMBIVENT CFC, Placebo CFC
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.

COMBIVENT HFADrug
Placebo HFADrug
COMBIVENT CFCDrug
Placebo CFCDrug

Study groups in NCT02194205
Study group	Role	What they receive
COMBIVENT HFA	Experimental	Not described Receives: Drug: COMBIVENT HFA
Placebo HFA	Placebo comparator	Not described Receives: Drug: Placebo HFA
COMBIVENT (CFC)	Active comparator	Not described Receives: Drug: COMBIVENT CFC
Placebo CFC	Placebo comparator	Not described Receives: Drug: Placebo CFC

What is being measured

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

Area under the curve from 0 to 6 hours (AUC0-6) of forced expiratory volume in the first second (FEV1)
Measured: after 12 weeks

Secondary outcomes (23)

Peak FEV1 response
Measured: 28 weeks
Onset of therapeutic FEV1 response
Measured: 28 weeks
Duration of therapeutic FEV1 response
Measured: 28 weeks
Time to peak FEV1 response
Measured: 28 weeks
Average FEV1 response as area under the curve from 0 - 6 hours divided by six (TAUC0-6)
Measured: 28 weeks
Average forced vital capacity (FVC) response area under the curve from 0 - 6 hours divided by six (AUC0-6)
Measured: 28 weeks
Number of participants requiring test-day rescue therapy
Measured: 28 weeks
Peak expiratory flow rate (PEFR)
Measured: 28 weeks
Daily COPD symptom scores
Measured: 28 weeks
Number of puffs of rescue medication
Measured: 28 weeks
Number and length of COPD exacerbations
Measured: 28 weeks
Average FEV1 response as area under the curve from 0 - 8 hours divided by six (TAUC0-8)
Measured: 28 weeks
Number of adverse events including paradoxical bronchoconstrictions
Measured: 28 weeks
Number of patients with clinically significant changes in pulse rate and blood pressure
Measured: 28 weeks
Plasma ipratropium concentration
Measured: pre-treatment, 5, 15, 30 min; 1, 2, 4 and 8 hours
Plasma albuterol concentration
Measured: pre-treatment, 5, 15, 30 min; 1, 2, 4 and 8 hours
Renal excretion of ipratropium fractions
Measured: pre-treatment, 0 - 2 hours, 2 - 8 hours
Renal excretion of albuterol fractions
Measured: pre-treatment, 0 - 2 hours, 2 - 8 hours
Physician's global evaluation on an 8-point scale
Measured: 28 weeks
Peak FVC response
Measured: 28 weeks
Number of patients with clinically significant changes in laboratory tests
Measured: 28 weeks
Number of patients with abnormal findings in physical examination
Measured: 28 weeks
Number of patients with clinically significant changes in electrocardiogram
Measured: 28 weeks

Timeline

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

Oct 2000Jun 2001

First posted18 Jul 2014 (estimated)
Study startOct 2000
Primary completionJun 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02194205
Sponsor's protocol ID: 1012.11
Status last verified: Jul 2014
First submitted: 17 Jul 2014
Last updated: 18 Jul 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A One-year Randomized, Double-blind, Placebo and Active-controlled Parallel Design Safety and Efficacy Comparison of COMBIVENT HFA Inhalation Aerosol to COMBIVENT (CFC) Inhalation Aerosol in Patients With COPD
ClinicalTrials.gov ID: NCT02194205
Acronym / sponsor ID: 1012.11
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 360 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2000
Primary completion: Jun 2001 (actual)
First posted: 18 Jul 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
COMBIVENT HFA	Experimental	Drug: COMBIVENT HFA
Placebo HFA	Placebo comparator	Drug: Placebo HFA
COMBIVENT (CFC)	Active comparator	Drug: COMBIVENT CFC
Placebo CFC	Placebo comparator	Drug: Placebo CFC

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

All patients must have a diagnosis of COPD
Male or female patients 40 years of age or older
Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
Patients must be able to perform technically satisfactory pulmonary function tests
Patients must be able to be trained in the proper use of a metered dose inhalator (MDI)

Key exclusion criteria (27 listed)

Patients with significant disease other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
All patients with a serum aspartate amino transferase (ASAT/SGOT) > 80 IU/L, serum alanine amino transferase (ALAT/SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these patients.
Patients who have a total bood eosinophil count >= 600 mm**3. A repeat eosinophil count will not be conducted in these patients
Patients with a recent history (i.e. one year or less) of myocardial infarction

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
COMBIVENT HFA	Drug	COMBIVENT HFA
Placebo HFA	Drug	Placebo HFA
COMBIVENT CFC	Drug	COMBIVENT (CFC)
Placebo CFC	Drug	Placebo CFC

Primary outcome

Area under the curve from 0 to 6 hours (AUC0-6) of forced expiratory volume in the first second (FEV1)
Time frame: after 12 weeks

23 secondary outcomes

Peak FEV1 response
Time frame: 28 weeks
Onset of therapeutic FEV1 response
Time frame: 28 weeks
Duration of therapeutic FEV1 response
Time frame: 28 weeks
Time to peak FEV1 response
Time frame: 28 weeks
Average FEV1 response as area under the curve from 0 - 6 hours divided by six (TAUC0-6)
Time frame: 28 weeks
Average forced vital capacity (FVC) response area under the curve from 0 - 6 hours divided by six (AUC0-6)
Time frame: 28 weeks
Number of participants requiring test-day rescue therapy
Time frame: 28 weeks
Peak expiratory flow rate (PEFR)
Time frame: 28 weeks
Daily COPD symptom scores
Time frame: 28 weeks
Number of puffs of rescue medication
Time frame: 28 weeks
Number and length of COPD exacerbations
Time frame: 28 weeks
Average FEV1 response as area under the curve from 0 - 8 hours divided by six (TAUC0-8)
Time frame: 28 weeks
Number of adverse events including paradoxical bronchoconstrictions
Time frame: 28 weeks
Number of patients with clinically significant changes in pulse rate and blood pressure
Time frame: 28 weeks
Plasma ipratropium concentration
Time frame: pre-treatment, 5, 15, 30 min; 1, 2, 4 and 8 hours
Plasma albuterol concentration
Time frame: pre-treatment, 5, 15, 30 min; 1, 2, 4 and 8 hours
Renal excretion of ipratropium fractions
Time frame: pre-treatment, 0 - 2 hours, 2 - 8 hours
Renal excretion of albuterol fractions
Time frame: pre-treatment, 0 - 2 hours, 2 - 8 hours
Physician's global evaluation on an 8-point scale
Time frame: 28 weeks
Peak FVC response
Time frame: 28 weeks
Number of patients with clinically significant changes in laboratory tests
Time frame: 28 weeks
Number of patients with abnormal findings in physical examination
Time frame: 28 weeks
Number of patients with clinically significant changes in electrocardiogram
Time frame: 28 weeks

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing COMBIVENT HFA and COMBIVENT CFC in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

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 7 inclusion and 27 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: stopped early, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

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 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 was stopped early. Results are not available in the source record.

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?

Area under the curve from 0 to 6 hours (AUC0-6) of forced expiratory volume in the first second (FEV1) (time frame: after 12 weeks). 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 NCT02194205.

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 18 Jul 2014.