Pulmonary Disease, Chronic ObstructivePhase 2NCT02242253
Free Combinations of Tiotropium Inhalation Powder Capsule + Salmeterol Metered Dose Inhaler, Tiotropium Inhalation Powder Capsule and Salmeterol Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Tiotropium and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Main Study: To evaluate and to compare the lung function response to the free combinations of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18 μg QD at the end of 6-week treatment periods 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?
- Tiotropium and Salmeterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jul 2004
- 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 must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must 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 must be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes have to be excluded)
- Patients must be able to perform technically acceptable pulmonary function tests and must be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol
- Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)
Who cannot join
- Patients with significant diseases 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 haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1
- Patients with a recent history (i.e. six months or less) of myocardial infarction
- Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalised for such an event within the past year
- Patients with a malignancy for which the patient has undergone resection, Radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
- Patients with known narrow-angle glaucoma
Show all 23Show fewer
- Patients with a history of asthma, allergic rhinitis or who have 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 have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
- Patients who regularly use daytime oxygen therapy
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Patients who are being treated with oral beta-adrenergics
- Patients who are being treated with cromolyn sodium or nedocromil sodium
- Patients who are being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion No. 7
- 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 medication 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 eg: Norplant®)
- Patients with previous participation (receipt of randomised treatment) in this study
- Patients who are currently participating in another study
- The randomisation of patients with any respiratory infection or COPD exacerbation in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomised six weeks following recovery from the infection or exacerbation
About this study
Official title: A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of the Free Combinations of Tiotropium Inhalation Powder Capsule (18 μg) QD + Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) QD or BID, Tiotropium Inhalation Powder Capsule (18 μg) QD and Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) BID in Patients With (COPD)
Main Study: To evaluate and to compare the lung function response to the free combinations of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18 μg QD at the end of 6-week treatment periods in patients with COPD.
Sub-Study: Was performed in subset of patients participating in the Main Study to assess the effect of the four randomised treatments on dynamic hyperinflation.
Extension Study: To establish whether the FEV1 time profile following combination bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical formulation of salmeterol, i.e. the MDI or the Diskus®.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, Salmeterol, Placebo-MDI, Placebo HandiHaler®
- 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.
TiotropiumDrug
administered via HandiHaler®
SalmeterolDrug
administered via metered dose inhaler (MDI)
Placebo-MDIDrug
Placebo HandiHaler®Drug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium+salmeterol QD | Experimental | free combination of tiotropium and salmeterol Receives: Drug: Tiotropium; Drug: Salmeterol; Drug: Placebo-MDI |
| Tiotropium+salmeterol BID | Active comparator | free combination of tiotropium and salmeterol Receives: Drug: Tiotropium; Drug: Salmeterol; Drug: Placebo-MDI |
| Tiotropium QD | Active comparator | Not described Receives: Drug: Tiotropium; Drug: Placebo-MDI |
| Salmeterol BID | Active comparator | Not described Receives: Drug: Salmeterol; Drug: Placebo HandiHaler® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of forced expiratory volume in one second (FEV1 AUC0-24h)
Measured: up to 12 hours after morning and evening dose
FEV1 AUC0-12h
Measured: up to 12 hours after morning and evening dose
Secondary outcomes (14)
FEV1 AUC12-24h
Measured: after 6 weeks of each treatment
AUC of forced vital capacity (FVC AUC0-12h)
Measured: after 6 weeks of each treatment
FVC AUC0-24h
Measured: after 6 weeks of each treatment
FVC AUC12-24h
Measured: after 6 weeks of each treatment
Peak FEV1
Measured: after 6 weeks of each treatment
Trough FEV1
Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the last administration of the morning dose of randomised treatment.
Measured: after 6 weeks of each treatment
Peak FVC
Measured: after 6 weeks of each treatment
Trough FVC
Trough FVC was defined as the pre-dose FVC measured just prior to the last administration of the morning dose of randomised treatment
Measured: after 6 weeks of each treatment
Individual FEV measurements at each time point
Measured: up to 6 weeks
Individual FVC measurements 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
Change in focal score of the Mahler Transition Dyspnea Index (TDI)
The TDI focal score is the sum of the three components of the TDI: Functional Impairment, Magnitude of Task and Magnitude of Effort
Measured: after 6 weeks of each treatment
Number of patients with adverse events
Measured: up to 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2003
- Primary completionJul 2004
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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242253
- Sponsor's protocol ID
- 1184.7
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 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 Combinations of Tiotropium Inhalation Powder Capsule (18 μg) QD + Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) QD or BID, Tiotropium Inhalation Powder Capsule (18 μg) QD and Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) BID in Patients With (COPD)
- ClinicalTrials.gov ID
- NCT02242253
- Acronym / sponsor ID
- 1184.7
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Jul 2004 (actual)
- First posted
- 17 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.
Main Study: To evaluate and to compare the lung function response to the free combinations of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18 μg QD at the end of 6-week treatment periods in patients with COPD.
Sub-Study: Was performed in subset of patients participating in the Main Study to assess the effect of the four randomised treatments on dynamic hyperinflation.
Extension Study: To establish whether the FEV1 time profile following combination bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical formulation of salmeterol, i.e. the MDI or the Diskus®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tiotropium+salmeterol QD | Experimental | Drug: Tiotropium, Drug: Salmeterol, Drug: Placebo-MDIfree combination of tiotropium and salmeterol |
| Tiotropium+salmeterol BID | Active comparator | Drug: Tiotropium, Drug: Salmeterol, Drug: Placebo-MDIfree combination of tiotropium and salmeterol |
| Tiotropium QD | Active comparator | Drug: Tiotropium, Drug: Placebo-MDI |
| Salmeterol BID | Active comparator | Drug: Salmeterol, Drug: Placebo HandiHaler® |
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 sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must 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 must be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes have to be excluded)
Key exclusion criteria (23 listed)
- Patients with significant diseases 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 haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1
- Patients with a recent history (i.e. six months or less) of myocardial infarction
- Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalised for such an event within the past year
- Patients with a malignancy for which the patient has undergone resection, Radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
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 |
|---|---|---|
| Tiotropiumadministered via HandiHaler® | Drug | Tiotropium QD, Tiotropium+salmeterol BID, Tiotropium+salmeterol QD |
| Salmeteroladministered via metered dose inhaler (MDI) | Drug | Salmeterol BID, Tiotropium+salmeterol BID, Tiotropium+salmeterol QD |
| Placebo-MDI | Drug | Tiotropium QD, Tiotropium+salmeterol BID, Tiotropium+salmeterol QD |
| Placebo HandiHaler® | Drug | Salmeterol BID |
Primary outcome
Area under the curve of forced expiratory volume in one second (FEV1 AUC0-24h)
Time frame: up to 12 hours after morning and evening dose
FEV1 AUC0-12h
Time frame: up to 12 hours after morning and evening dose
14 secondary outcomes
FEV1 AUC12-24h
Time frame: after 6 weeks of each treatment
AUC of forced vital capacity (FVC AUC0-12h)
Time frame: after 6 weeks of each treatment
FVC AUC0-24h
Time frame: after 6 weeks of each treatment
FVC AUC12-24h
Time frame: after 6 weeks of each treatment
Peak FEV1
Time frame: after 6 weeks of each treatment
Trough FEV1
Time frame: after 6 weeks of each treatment
Peak FVC
Time frame: after 6 weeks of each treatment
Trough FVC
Time frame: after 6 weeks of each treatment
Individual FEV measurements at each time point
Time frame: up to 6 weeks
Individual FVC measurements at each time point
Time frame: up to 6 weeks
Peak expiratory flow rate (PEFR) measured twice daily
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
Change in focal score of the Mahler Transition Dyspnea Index (TDI)
Time frame: after 6 weeks of each treatment
Number of patients with adverse events
Time frame: up to 33 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 17 Sep 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium and Salmeterol 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 23 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 17 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?
Area under the curve of forced expiratory volume in one second (FEV1 AUC0-24h) (time frame: up to 12 hours after morning and evening dose). 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?
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 17 Sep 2014.