Lung Function Changes Following the Addition of Formoterol to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02242240 | Completed Phase 2

• 1 other identifier: 1184.2
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to establish the lung function effects of added formoterol (12μg QD and BID) during 2-week periods to pharmacodynamic steady state of tiotropium(18μg QD)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Area under the curve from time point zero to 24 hours (AUC0-24h) for forced expiratory volume in one second (FEV1)

  Pre-dose, up to 24 hours after start of treatment

• Area under the curve from 12 to 24 hours (AUC12-24h) for forced expiratory volume in one second (FEV1)

  12 to 24 hours after start of treatment

Secondary Outcomes (12)

• Trough FEV1 response on each pulmonary function test day

  24 hours after intake of the last morning dose

• Trough forced vital capacity (FVC) response on each pulmonary function test day

  Up to 24 hours after start of treatment

• FEV1 AUC0-12h on each pulmonary function test day

  Up to 12 hours after start of treatment

• Individual FEV1measurements at each time point

  up to day 58 day after start of treatment

• Individual FVC measurements at each time point

  up to day 58 day after start of treatment

Study Arms (3)

Tiotropium with single dose of formoterol

EXPERIMENTAL

Drug: Formoterol once daily; Drug: Tiotropium once daily

Tiotropium with double dose of formoterol

EXPERIMENTAL

Drug: Formoterol twice daily; Drug: Tiotropium once daily

Tiotropium with Placebo

EXPERIMENTAL

Drug: Tiotropium once daily; Drug: Placebo

Interventions

Formoterol twice daily DRUG

Tiotropium with double dose of formoterol

Formoterol once daily DRUG

Tiotropium with single dose of formoterol

Tiotropium once daily DRUG

Tiotropium with Placebo; Tiotropium with double dose of formoterol; Tiotropium with single dose of formoterol

Placebo DRUG

Tiotropium with Placebo

Eligibility Criteria

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

You may qualify if:

• All patients must sign an informed consent consistent with international conference of harmonization (ICH)-good clinical practice (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 (Visit 1)
• \* Patients who have frequent exacerbations (at least three in the preceding year) which could be expected to interfere with the patient's ability to participate in the trial should be excluded. The enrollment of patients who have had an exacerbation within the six-week period prior to planned study entry should be postponed for at least six weeks
• Predicted normal values will be calculated according to european community for coal and steel (ECCS):
• Males: FEV1 predicted (L) = 4.30 x Height (metres) - 0.029 x Age (years) - 2.49
• Females: FEV1 predicted (L) = 3.95 x Height (metres) - 0.025 x Age (years) - 2.60
• 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 have never smoked cigarettes must be excluded
• Patients must be able to perform technically acceptable pulmonary function tests and must be able to maintain records (Patient Daily Record) during the study period as required in the protocol
• Patients must be able to inhale medication from inhalation capsule delivery systems (the HandiHaler® for the tiotropium and placebo capsules and the Aerolizer® for the formoterol capsule) and from a metered dose inhaler

You may not qualify if:

• 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
• All patients with a 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) will be excluded regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these patients
• Patients with a recent history (i.e., six months or less) of myocardial infarction
• Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalized for heart failure within the past three years
• Patients with known active tuberculosis
• Patients on oxygen therapy
• Patients with history of cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
• Patients with any respiratory infection in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period
• Patients with known hypersensitivity to anticholinergic drugs, beta adrenergics, lactose or any other components of the inhalation capsule delivery system
• Patients with a history of cancer within the last three years. Patients with treated basal cell carcinoma are allowed. Patients with successfully treated cancers greater than five years prior to entry will be allowed
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
• Patients with known narrow-angle glaucoma
• Patients using cromolyn sodium or nedocromil sodium
• Patients using treated with antihistamines (H1 receptor antagonists)
• Patients using treated with theophyllines

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: March 1, 2001
• Primary Completion: December 1, 2001
• Last Updated: September 17, 2014

Record last verified: 2014-09