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

NCT02238119 | Completed Phase 2

• 1 other identifier: 1184.3
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Change in area under the curve from pre-dose to 12 hours of the forced expiratory volume in one second (FEV1 AUC0-12h)

  after 6 weeks of each treatment

• Change in FEV1 AUC0-24h

  after 6 weeks of each treatment

Secondary Outcomes (15)

• Change in FEV1 AUC12-24h

  after 6 weeks of each treatment

• Change in AUC of the forced vital capacity (FVC AUC0-12h)

  after 6 weeks of each treatment

• Change in FVC AUC0-24h

  after 6 weeks of each treatment

• Change in FVC AUC12-24h

  after 6 weeks of each treatment

• Change in peak FEV1 response

  after 6 weeks of each treatment

Study Arms (3)

tiotropium + formoterol

EXPERIMENTAL

Drug: Tiotropium + formoterol combination

tiotropium

ACTIVE COMPARATOR

Drug: Tiotropium

formoterol

ACTIVE COMPARATOR

Drug: Formoterol

Interventions

Tiotropium + formoterol combination DRUG

tiotropium + formoterol

Tiotropium DRUG

tiotropium

Formoterol DRUG

formoterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• 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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 12, 2014
• Study Start: February 1, 2002
• Primary Completion: August 1, 2002
• Last Updated: September 12, 2014

Record last verified: 2014-09