4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma

NCT00818454 | Completed Phase 2 Results

• 2 other identifiers: 1012.5757948
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 41

Brief Summary

The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3) COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will be used for symptom relief as needed.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• FEV1 AUC0-6 Response (Crossover Part of the Study)

  Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.

  Test day baseline and test day FEV1 AUC 0-6, after 4 weeks

• Peak FEV1 Response (Crossover Part of the Study)

  Change from baseline after 4 weeks in peak Forced Expiratory Volume response

  Test day baseline and test day peak FEV1, after 4 weeks

Secondary Outcomes (8)

• Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)

  Baseline, 4 weeks

• Asthma Control Questionnaire (Crossover Part of the Study)

  Baseline, 4 weeks

• Puffs Study Medication Used During Day (Crossover Part of the Study)

  Baseline, 4 weeks

• Puffs Study Medication Used During Night (Crossover Part of the Study)

  Baseline, 4 weeks

• Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)

  Baseline, 4 weeks

Interventions

Combivent CFC MDI DRUG

Albuterol HFA MDI DRUG

Respimat Combivent DRUG

Eligibility Criteria

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

You may qualify if:

• All patients must sign and date an Informed Consent consistent with International Conference on Harmonization Good Clinical Practices (ICH GCP) guidelines and local regulations prior to participation in the trial (i.e., prior to any study procedures, including washout of any medication) at Visit 1.
• Male or female patients greater to or equal to 18 years of age.
• Physician diagnosis of moderate-to-severe asthma (GINA Guidelines) existing for \>1 year.
• Reversible airway obstruction (more than or equal to 12 % or at least 200 mL improvement in FEV1 post bronchodilator after 4 puffs of albuterol HFA MDI).
• Pre-bronchodilator clinic measured FEV1 ≤80% of predicted normal value (measured greater to or equal to 6 hours of the last use of short acting bronchodilator and greater to or equal to 12 hours after the last use of LABA if applicable).
• Continuous treatment with inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA) and other controller medication(s) for at least 6 weeks prior to screening (GINA 2007 Treatment Steps 3 to 5).
• No change in dos or regimen of ICS and LABA or other controller medications (including oral corticosteroids \[OCS\] if applicable), for at least 2 weeks prior to Visit 2.
• Use of short acting bronchodilator at least three times a week for symptom relief in the 2 weeks prior to Visit 1.
• Score of ≥1.5 points on the Asthma Control Questionnaire (ACQ) (see Appendix 10.6).
• Able to perform technically acceptable pulmonary function tests at the clinic and peak flow measurements with the eDiary/Peak Expiratory Flow Meter.
• Able to perform all necessary recordings (symptoms and as needed medication use) in the electronic diary, which is a part of the eDiary/Peak Expiratory Flow Meter.
• Investigator assessment of patients ability to inhale medication from a metered dose inhaler and RESPIMAT inhaler.

You may not qualify if:

• Significant disease other than asthma not limited to diagnosis of COPD, such as, active tuberculosis, cystic fibrosis, alpha 1 antitrypsin deficiency, clinically significant bronchiectasis, interstitial lung disease, allergic bronchopulmonary aspergillosis, or constrictive bronchiolitis. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, or (ii) influence the results of the study, or (iii) cause concern regarding the patient ability to participate in the study.
• History of life-threatening asthma attack.
• Worsening of asthma that required treatment with an addition or increase in OCS dose (steroid burst) in the 4- week period prior to Visit 2.
• Current or ex-smokers who quit \<1 year before enrollment. Ex-smokers who quit less than 1 year from enrollment must have a cigarette smoking history of less than 10 pack years.
• Pack years = Number of cigarettes/day x years of smoking 20
• Use of oral beta-adrenergic agents within 4 weeks prior to screening.
• Treatment with inhaled ipratropium, ipratropium/albuterol combination, or nasal ipratropium within 1week of Visit 2.
• Treatment with inhaled tiotropium within 4 weeks of Visit 2.
• Known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetracetic acid (EDTA) or any other components of the tiotropium inhalation solution or MDI.
• Known narrow-angle glaucoma.
• Recent history (i.e., one year less) of myocardial infarction. Cardiac arrhythmias, newly diagnosed arrhythmias and/or any arrhythmia requiring an intervention (i.e., hospitalization, cardio version, pacemaker placement, and automatic implantable cardiac defibrillator placement) or a change in drug therapy during the last year.
• Hospitalization for cardiac failure during the past year.
• Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years, with the exception of treated basal cell carcinoma.
• Unwillingness or inability to use a highly effective method of birth control by women of childbearing potential. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner. Barrier methods of contraception are accepted if condom or occlusive cap is used together with spermicides (e.g., foam or gel). Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
• Pregnancy or nursing.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (41)

1012.57.121 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1012.57.144 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1012.57.145 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1012.57.124 Boehringer Ingelheim Investigational Site

Palmdale, California, United States

Location

1012.57.137 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1012.57.130 Boehringer Ingelheim Investigational Site

Stockton, California, United States

Location

1012.57.134 Boehringer Ingelheim Investigational Site

Centennial, Colorado, United States

Location

1012.57.151 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1012.57.119 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

1012.57.149 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Location

1012.57.104 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Location

1012.57.107 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

1012.57.127 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

Location

1012.57.140 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

1012.57.143 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1012.57.126 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1012.57.147 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1012.57.113 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

1012.57.131 Boehringer Ingelheim Investigational Site

Plymouth, Minnesota, United States

Location

1012.57.116 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1012.57.146 Boehringer Ingelheim Investigational Site

Bozeman, Montana, United States

Location

1012.57.132 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1012.57.139 Boehringer Ingelheim Investigational Site

Skillman, New Jersey, United States

Location

1012.57.109 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

1012.57.118 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1012.57.128 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1012.57.102 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1012.57.129 Boehringer Ingelheim Investigational Site

Lake Oswego, Oregon, United States

Location

1012.57.138 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1012.57.108 Boehringer Ingelheim Investigational Site

Hershey, Pennsylvania, United States

Location

1012.57.114 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1012.57.111 Boehringer Ingelheim Investigational Site

Upland, Pennsylvania, United States

Location

1012.57.142 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1012.57.117 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1012.57.103 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

1012.57.136 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Location

1012.57.148 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1012.57.101 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1012.57.141 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Location

1012.57.150 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1012.57.105 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Location

Related Publications (1)

• Donohue JF, Wise R, Busse WW, Garfinkel S, Zubek VB, Ghafouri M, Manuel RC, Schlenker-Herceg R, Bleecker ER. Efficacy and safety of ipratropium bromide/albuterol compared with albuterol in patients with moderate-to-severe asthma: a randomized controlled trial. BMC Pulm Med. 2016 Apr 30;16(1):65. doi: 10.1186/s12890-016-0223-3.

  PMID: 27130202 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Albuterol, Ipratropium Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Ipratropium; 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 2
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2009
• Last Updated: February 14, 2014
• Results First Posted: November 23, 2010

Record last verified: 2014-01

Locations

US (41)