Pulmonary Disease, Chronic ObstructivePhase 2NCT02238119

Efficacy and Safety of Free Combination of Tiotropium + Formoterol Compared to Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing Tiotropium + formoterol combination, Tiotropium and Formoterol 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 evaluate the lung function response to the free once-daily combination of tiotropium + formoterol compared to formoterol BID and tiotropium QD 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?: Tiotropium + formoterol combination, Tiotropium and Formoterol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: No sites listed yet
Study dates: Feb 2002to Aug 2002
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 had to sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which included medication washout and restrictions
All patients had to have a diagnosis of chronic obstructive pulmonary disease and had to meet the following spirometric criteria:
Patients had to have relatively stable moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visits 1 and 2)
Male or female patients 40 years of age or older
Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes had to be excluded)
Patients had to be able to perform technically acceptable pulmonary function tests and had to be able to maintain records (Patient Daily Diary Record) during the study period as required in the protocol
Patients had to be able to inhale medication in a competent manner from the HandiHaler® device, the Blue Inhaler device and from a metered dose inhaler (MDI)

Who cannot join

Patients with significant diseases other than COPD had to be excluded. A significant disease was 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 haematology, blood chemistry, or urinalysis if the abnormality defined a disease listed as an exclusion criterion
All patients with an serum glutamate oxaloacetate transaminase (SGOT) > 80 IU/L, serum glutamate pyruvate transaminase (SGPT) > 80 IU/L, bilirubin > 17 μmol/L or creatinine > 110 μmol/L (males) / 95 μmol/L (females) had to be excluded regardless of clinical condition
Patients with a recent history (i.e., six months or less) of myocardial infarction
Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years
Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed

Show all 25Show fewer

Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
Patients with prostatic hypertrophy controlled by medication were allowed
Patients with known narrow-angle glaucoma
Patients with a history of asthma, allergic rhinitis or who had a total blood eosinophil count ≥600 mm3
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
Patients with known active tuberculosis
Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
Patients who had undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons had to be evaluated as per exclusion criterion No. 1
Patients who completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
Patients who regularly used daytime oxygen therapy
Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
Patients who were treated with beta-blocker medications. Note: cardioselective beta blocker eye medications (e.g. Betoptic®) for treatment of non-narrow angle glaucoma were allowed
Patients who were treated with oral beta-adrenergics
Patients who were treated with cromolyn sodium or nedocromil sodium
Patients who were treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion No. 9
Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
Patients with known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other components of the inhalation capsule delivery systems
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous 3 months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g., Norplant®)
Patients with previous participation (receipt of randomised treatment) in this study

About this study

Official title: A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of the Free Combination of Tiotropium Inhalation Powder Capsule (18 μg) + Formoterol Inhalation Powder Capsule (12 μg) QD, Tiotropium Inhalation Powder Capsule (18 μg) QD and Formoterol Inhalation Powder Capsule (12 μg) BID in Patients With COPD

Study to evaluate the lung function response to the free once-daily combination of tiotropium + formoterol compared to formoterol BID and tiotropium QD

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium + formoterol combination, Tiotropium, Formoterol
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.

Tiotropium + formoterol combinationDrug
TiotropiumDrug
FormoterolDrug

Study groups in NCT02238119
Study group	Role	What they receive
tiotropium + formoterol	Experimental	Not described Receives: Drug: Tiotropium + formoterol combination
tiotropium	Active comparator	Not described Receives: Drug: Tiotropium
formoterol	Active comparator	Not described Receives: Drug: Formoterol

What is being measured

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

Change in area under the curve from pre-dose to 12 hours of the forced expiratory volume in one second (FEV1 AUC0-12h)
Measured: after 6 weeks of each treatment
Change in FEV1 AUC0-24h
Measured: after 6 weeks of each treatment

Secondary outcomes (15)

Change in FEV1 AUC12-24h
Measured: after 6 weeks of each treatment
Change in AUC of the forced vital capacity (FVC AUC0-12h)
Measured: after 6 weeks of each treatment
Change in FVC AUC0-24h
Measured: after 6 weeks of each treatment
Change in FVC AUC12-24h
Measured: after 6 weeks of each treatment
Change in peak FEV1 response
Measured: after 6 weeks of each treatment
Change in trough FEV1 response
Measured: after 6 weeks of each treatment
Change in peak FVC response
Measured: after 6 weeks of each treatment
Change in trough FVC response
Measured: after 6 weeks of each treatment
Individual FEV1measurements at each time point
Measured: up to 6 weeks
Individual FVCmeasurements at each time point
Measured: up to 6 weeks
Peak expiratory flow rate (PEFR)
measured twice daily
Measured: weeks 4 to 6 of each treatment period
Number of inhalations of rescue salbutamol therapy used per day
Measured: weeks 4 to 6 of each treatment period
Assessment of daytime COPD symptom score rated on a 6-point rating scale
Measured: weeks 4 to 6 of each treatment period
Assessment of nighttime COPD symptom score rated on a 5-point rating scale
Measured: weeks 4 to 6 of each treatment period
Number of patients with adverse events
Measured: up to 23 weeks

Timeline

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

Feb 2002Aug 2002

First posted12 Sep 2014 (estimated)
Study startFeb 2002
Primary completionAug 2002

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: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02238119
Sponsor's protocol ID: 1184.3
Status last verified: Sep 2014
First submitted: 11 Sep 2014
Last updated: 12 Sep 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 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of the Free Combination of Tiotropium Inhalation Powder Capsule (18 μg) + Formoterol Inhalation Powder Capsule (12 μg) QD, Tiotropium Inhalation Powder Capsule (18 μg) QD and Formoterol Inhalation Powder Capsule (12 μg) BID in Patients With COPD
ClinicalTrials.gov ID: NCT02238119
Acronym / sponsor ID: 1184.3
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2002
Primary completion: Aug 2002 (actual)
First posted: 12 Sep 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 to evaluate the lung function response to the free once-daily combination of tiotropium + formoterol compared to formoterol BID and tiotropium QD

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
tiotropium + formoterol	Experimental	Drug: Tiotropium + formoterol combination
tiotropium	Active comparator	Drug: Tiotropium
formoterol	Active comparator	Drug: Formoterol

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 had to sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which included medication washout and restrictions
All patients had to have a diagnosis of chronic obstructive pulmonary disease and had to meet the following spirometric criteria:
Male or female patients 40 years of age or older
Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes had to be excluded)
Patients had to be able to perform technically acceptable pulmonary function tests and had to be able to maintain records (Patient Daily Diary Record) during the study period as required in the protocol

Key exclusion criteria (25 listed)

Patients with significant diseases other than COPD had to be excluded. A significant disease was 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 haematology, blood chemistry, or urinalysis if the abnormality defined a disease listed as an exclusion criterion
All patients with an serum glutamate oxaloacetate transaminase (SGOT) > 80 IU/L, serum glutamate pyruvate transaminase (SGPT) > 80 IU/L, bilirubin > 17 μmol/L or creatinine > 110 μmol/L (males) / 95 μmol/L (females) had to be excluded regardless of clinical condition
Patients with a recent history (i.e., six months or less) of myocardial infarction
Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years

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
Tiotropium + formoterol combination	Drug	tiotropium + formoterol
Tiotropium	Drug	tiotropium
Formoterol	Drug	formoterol

Primary outcome

Change in area under the curve from pre-dose to 12 hours of the forced expiratory volume in one second (FEV1 AUC0-12h)
Time frame: after 6 weeks of each treatment
Change in FEV1 AUC0-24h
Time frame: after 6 weeks of each treatment

15 secondary outcomes

Change in FEV1 AUC12-24h
Time frame: after 6 weeks of each treatment
Change in AUC of the forced vital capacity (FVC AUC0-12h)
Time frame: after 6 weeks of each treatment
Change in FVC AUC0-24h
Time frame: after 6 weeks of each treatment
Change in FVC AUC12-24h
Time frame: after 6 weeks of each treatment
Change in peak FEV1 response
Time frame: after 6 weeks of each treatment
Change in trough FEV1 response
Time frame: after 6 weeks of each treatment
Change in peak FVC response
Time frame: after 6 weeks of each treatment
Change in trough FVC response
Time frame: after 6 weeks of each treatment
Individual FEV1measurements at each time point
Time frame: up to 6 weeks
Individual FVCmeasurements at each time point
Time frame: up to 6 weeks
Peak expiratory flow rate (PEFR)
Time frame: weeks 4 to 6 of each treatment period
Number of inhalations of rescue salbutamol therapy used per day
Time frame: weeks 4 to 6 of each treatment period
Assessment of daytime COPD symptom score rated on a 6-point rating scale
Time frame: weeks 4 to 6 of each treatment period
Assessment of nighttime COPD symptom score rated on a 5-point rating scale
Time frame: weeks 4 to 6 of each treatment period
Number of patients with adverse events
Time frame: up to 23 weeks

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 Sep 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 2 study testing Tiotropium + formoterol combination, Tiotropium and Formoterol 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 25 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 Sep 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. 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 area under the curve from pre-dose to 12 hours of the forced expiratory volume in one second (FEV1 AUC0-12h) (time frame: after 6 weeks of each treatment). The study lists 2 primary outcomes in all. 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 NCT02238119.

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 Sep 2014.