Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease

NCT01019694 | Completed Phase 3 Results

• 1 other identifier: 1012.62
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 55

Brief Summary

The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48

  Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).

  48 weeks

Secondary Outcomes (38)

• Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3

  3 weeks

• Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12

  12 weeks

• Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24

  24 weeks

• Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36

  36 weeks

• Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0

  0 weeks

Study Arms (3)

Combivent Respimat 20/100 microgram(mcg)

EXPERIMENTAL

patient to take 1 inhalation 4 times a day

Drug: Combivent Respimat 20/100 mcg

Combivent CFC-MDI 36/206 microgram-mcg

ACTIVE COMPARATOR

patient to take 2 inhalations 4 times a day

Drug: Combivent CFC-MDI

Atrovent HFA 42 mcg + Albuterol HFA

ACTIVE COMPARATOR

patient to take 2 inhalations of each 4 times a day

Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg

Interventions

Combivent CFC-MDI DRUG

36/206 mcg Four times a day (QID)

Combivent CFC-MDI 36/206 microgram-mcg

Combivent Respimat 20/100 mcg DRUG

Open label randomized parallel

Combivent Respimat 20/100 microgram(mcg)

Atrovent HFA 42 mcg + Albuterol HFA 200 mcg DRUG

Open label randomized parallel

Atrovent HFA 42 mcg + Albuterol HFA

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 on Harmonization (ICH) Good Clinical Practice (GCP) guidelines prior to participation in the trial.
• Male or female patients 40 years of age or older.
• Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded) Pack Years = Number of cigarettes/day x years of smoking 20 cigarettes/pack
• All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (P95-4381), and must meet the following spirometric criteria at Visit 1:Relatively stable, moderate to severe airway obstruction with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% of predicted normal and FEV1/Forced Vital Capacity (FVC) \< 70%. Spirometry should be done at baseline and approximately 1/2 hour following 4 inhalations of albuterol. Predicted normal values will be calculated according to European Coal and Steel Community (ECSC), European Community for Coal and Steel (ECCS), (R94-1408). For Height measured in inches Males: FEV1 predicted (L) = 4.30 x \[height (inches) / 39.37\]-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x \[height (inches) / 39.37\]-0.025 x age (yrs) - 2.60 For Height measured in meters Males: FEV1 predicted (L) = 4.30 x \[height (meters)\] - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x \[height (meters)\] - 0.025 x age (years) - 2.60
• Patients must be able to perform all study related procedures and maintain study records during the study period as required in the protocol.
• Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).

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.
• Patients with a recent history (i.e., one year or less) of myocardial infarction.
• Patients who have been hospitalized or being treated for heart failure within the past year.
• Patients with clinically unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy within the past year.
• Patients with a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with fully cured squamous cell or treated basal cell carcinoma are allowed).
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
• Patients with a current diagnosis of asthma.
• Patients with a history of significant alcohol or drug abuse.
• Patients with known active tuberculosis.
• Patients using beta blocker medications are excluded. Cardioselective beta blockers are allowed with caution. Beta blocker eye medications for treatment of non-narrow angle glaucoma are allowed.
• Patients who regularly use daytime oxygen therapy for more than 1 hour per day Continuous Positive Airway Pressure (CPAP for sleep apnea is allowed).
• Patients using oral corticosteroid medication at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, except as required for treatment of exacerbation during the study.
• Pregnant or nursing women.
• Women of childbearing potential not using a medically approved means of contraception (i.e., oral or injectable contraceptives, intrauterine devices or diaphragm with spermicide, or transdermal hormonal patches). Abstinence will not be accepted as a medically approved means of contraception. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
• Patients with known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide/albuterol RESPIMAT solution including Benzalkonium chloride (BAC) and Ethylenediaminetetraacetic acid (EDTA) or the ipratropium bromide/albuterol Chlorofluorocarbons (CFC) MDI or Hydrofluoroalkane (HFA) components.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (55)

1012.62.153 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

1012.62.145 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1012.62.156 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Location

1012.62.135 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

1012.62.141 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Location

1012.62.155 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Location

1012.62.126 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Location

1012.62.131 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1012.62.144 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Location

1012.62.123 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

1012.62.114 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1012.62.124 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1012.62.139 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Location

1012.62.134 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1012.62.115 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Location

1012.62.146 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1012.62.113 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

1012.62.157 Boehringer Ingelheim Investigational Site

Dubuque, Iowa, United States

Location

1012.62.159 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

1012.62.116 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Location

1012.62.148 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

1012.62.137 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1012.62.132 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

1012.62.117 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Location

1012.62.158 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

1012.62.127 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1012.62.129 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1012.62.147 Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

Location

1012.62.149 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Location

1012.62.112 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1012.62.111 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

1012.62.107 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1012.62.120 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1012.62.150 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Location

1012.62.103 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1012.62.104 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1012.62.154 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Location

1012.62.128 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1012.62.130 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1012.62.151 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1012.62.161 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1012.62.109 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1012.62.118 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1012.62.125 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1012.62.140 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

1012.62.143 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1012.62.152 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1012.62.102 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1012.62.122 Boehringer Ingelheim Investigational Site

Danville, Virginia, United States

Location

1012.62.119 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1012.62.142 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1012.62.108 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1012.62.133 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1012.62.105 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1012.62.101 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Location

Related Publications (1)

• Ferguson GT, Ghafouri M, Dai L, Dunn LJ. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. Int J Chron Obstruct Pulmon Dis. 2013;8:139-50. doi: 10.2147/COPD.S38577. Epub 2013 Mar 19.

  PMID: 23658479 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol, Ipratropium Drug Combination; Ipratropium

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)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2011
• Last Updated: October 23, 2014
• Results First Posted: May 1, 2012

Record last verified: 2014-10

Locations

US (55)