Pulmonary Disease, Chronic ObstructivePhase 2NCT02182674

A Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing Combivent HFA and Combivent (CFC) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

Completed

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

Official record

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Trial summary

Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA) inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg… 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: 66 participants
Where: No sites listed yet
Study dates: Oct 2000to Aug 2001
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients were to have a diagnosis of COPD and must have met the following criteria at visit 1: Patients were to have relatively stable, moderate to severe airway obstruction with a baseline forced expiratory volume in one second (FEV1) <=65 % of predicted normal and FEV1 / forced vital capacity (FVC) <=70 %.
Patients must have demonstrated a >= 015 % improvement in baseline FEV1 within one hour after the inhalation of two puffs of Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate per actuation; ex-mouthpiece dose)
Male or female patients 40 years of age or older.
Patients must have had a smoking history of more than ten pack-year. A pack-year is defined as the equivalent of smoking on pack of 20 cigarettes per day for a year.
Patients must have been able to perform technical satisfactory pulmonary function test.
Patients must have been able to be trained in the proper use of a metered dose inhalator (MDI)
All patients must have signed an informed consent form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications.

Who cannot join

Patients with significant disease other than COPD were to 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 clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion, the patient was to be excluded.
All patients with a serum glutamic-oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL were to be excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these patients.
Patients who had total blood eosinophil count >= 600/mm³. A repeat eosinophil count was not to 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.

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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 with a history or a thoracotomy for other reasons were to be evaluated as per exclusion criteria 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 screening visit (Visit 1) or between the screening visit and visit 2.
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
Patients with known narrow-angle glaucoma.
Patients with current significant psychiatric disorder.
Patients with regular use of daytime oxygen therapy.
Patients who were being treated with beta blocker medication, mono amine oxidase (MAO) inhibitors or tricyclic antidepressants.
Patients who were being treated with cromolyn sodium or nedocromil sodium.
Patients who were being treated with antihistamines.
Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose before screening visit or a change between the screening visit and visit 2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
Patients who had been treated with oral beta adrenergics or long-acting beta-adrenergics such as salmeterol (Serevent) and formoterol in the two weeks prior to the screening visit or between the screening visit and visit 2.
Patients who have had changes in their therapeutic plan within the last six weeks prior to the screening visit or between the screening visit and visit 2, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial.
Pregnant or nursing women or women 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 had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit.
Previous participation in this study.

About this study

Official title: A Randomized, Double Blind, Crossover, Placebo- and Active Controlled Dose Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With COPD

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Placebo Combivent HFA, Combivent HFA, Combivent (CFC), Placebo Combivent (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.

Placebo Combivent HFADrug
Combivent HFADrug
Combivent (CFC)Drug
Placebo Combivent (CFC)Drug

Study groups in NCT02182674
Study group	Role	What they receive
Combivent HFA	Experimental	Not described Receives: Drug: Placebo Combivent HFA; Drug: Combivent HFA
Combivent (CFC)	Active comparator	Not described Receives: Drug: Combivent (CFC); Drug: Placebo Combivent (CFC)

What is being measured

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

Average forced expiratory volume in the first second (FEV1) response calculated as area under the curve above test-day baseline from time 0 to 6 hours divided by six (AUC0-6h)
Measured: 0, 1, 2, 3, 4, 5 and 6 hours post drug administration

Secondary outcomes (17)

onset of therapeutic FEV1 response
Measured: up to 8 hours post drug administration
peak FEV1
Measured: up to 8 hours post drug administration
time to peak FEV1
Measured: up to 8 hours post drug administration
average of FEV1, pictured as area under the curve (AUC0-8h)
Measured: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
individual FEV1
Measured: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
individual forced vital capacity (FVC)
Measured: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
average of FVC, pictured as area under the curve (AUC0-8h)
Measured: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
peak FVC
Measured: up to 8 hours post drug administration
ipratropium plasma concentration
Measured: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
albuterol plasma concentration
Measured: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
ipratropium amount from renal excretion (Ae0-2, Ae0-8)
Measured: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration
albuterol amount from renal excretion (Ae0-2, Ae0-8)
Measured: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration
ipratropium plasma concentration (AUC0-8h)
Measured: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
albuterol plasma concentration (AUC0-8h)
Measured: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
number of patients with Adverse Events
Measured: up to day 49 after first drug administartion
change from baseline in pulse rate and blood pressure
Measured: up to day 49 after first drug administartion
change from baseline in physical examination, laboratory test and 12-lead ECG
Measured: up to day 49 after first drug administartion

Timeline

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

Oct 2000Aug 2001

First posted8 Jul 2014 (estimated)
Study startOct 2000
Primary completionAug 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02182674
Sponsor's protocol ID: 1012.25
Status last verified: Aug 2018
First submitted: 3 Jul 2014
Last updated: 31 Aug 2018
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

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Crossover, Placebo- and Active Controlled Dose Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With COPD
ClinicalTrials.gov ID: NCT02182674
Acronym / sponsor ID: 1012.25
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2000
Primary completion: Aug 2001 (actual)
First posted: 8 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: Crossover
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Combivent HFA	Experimental	Drug: Placebo Combivent HFA, Drug: Combivent HFA
Combivent (CFC)	Active comparator	Drug: Combivent (CFC), Drug: Placebo Combivent (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 were to have a diagnosis of COPD and must have met the following criteria at visit 1: Patients were to have relatively stable, moderate to severe airway obstruction with a baseline forced expiratory volume in one second (FEV1) <=65 % of predicted normal and FEV1 / forced vital capacity (FVC) <=70 %.
Patients must have demonstrated a >= 015 % improvement in baseline FEV1 within one hour after the inhalation of two puffs of Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate per actuation; ex-mouthpiece dose)
Male or female patients 40 years of age or older.
Patients must have had a smoking history of more than ten pack-year. A pack-year is defined as the equivalent of smoking on pack of 20 cigarettes per day for a year.
Patients must have been able to perform technical satisfactory pulmonary function test.

Key exclusion criteria (27 listed)

Patients with significant disease other than COPD were to 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 clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion, the patient was to be excluded.
All patients with a serum glutamic-oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL were to be excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these patients.
Patients who had total blood eosinophil count >= 600/mm³. A repeat eosinophil count was not to 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
Placebo Combivent HFA	Drug	Combivent HFA
Combivent HFA	Drug	Combivent HFA
Combivent (CFC)	Drug	Combivent (CFC)
Placebo Combivent (CFC)	Drug	Combivent (CFC)

Primary outcome

Average forced expiratory volume in the first second (FEV1) response calculated as area under the curve above test-day baseline from time 0 to 6 hours divided by six (AUC0-6h)
Time frame: 0, 1, 2, 3, 4, 5 and 6 hours post drug administration

17 secondary outcomes

onset of therapeutic FEV1 response
Time frame: up to 8 hours post drug administration
peak FEV1
Time frame: up to 8 hours post drug administration
time to peak FEV1
Time frame: up to 8 hours post drug administration
average of FEV1, pictured as area under the curve (AUC0-8h)
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
individual FEV1
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
individual forced vital capacity (FVC)
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
average of FVC, pictured as area under the curve (AUC0-8h)
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
peak FVC
Time frame: up to 8 hours post drug administration
ipratropium plasma concentration
Time frame: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
albuterol plasma concentration
Time frame: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
ipratropium amount from renal excretion (Ae0-2, Ae0-8)
Time frame: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration
albuterol amount from renal excretion (Ae0-2, Ae0-8)
Time frame: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration
ipratropium plasma concentration (AUC0-8h)
Time frame: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
albuterol plasma concentration (AUC0-8h)
Time frame: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
number of patients with Adverse Events
Time frame: up to day 49 after first drug administartion
change from baseline in pulse rate and blood pressure
Time frame: up to day 49 after first drug administartion
change from baseline in physical examination, laboratory test and 12-lead ECG
Time frame: up to day 49 after first drug administartion

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 31 Aug 2018.
Related InfoLink provided by the sponsor.

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)
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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 2 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: finished, as of the sponsor's last update on 31 Aug 2018. 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. 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?

Average forced expiratory volume in the first second (FEV1) response calculated as area under the curve above test-day baseline from time 0 to 6 hours divided by six (AUC0-6h) (time frame: 0, 1, 2, 3, 4, 5 and 6 hours post drug administration). 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 NCT02182674.

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 31 Aug 2018.