Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nintedanib DPI 4X day | Experimental | Inhalable |
|
| Placebo 4X day | Placebo Comparator | Inhalable |
|
| Nintedanib 2X day | Experimental | Inhalable |
|
| Placebo 2X day | Placebo Comparator | Inhalable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib Dry Powder Inhalation | Drug | Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Efficacy | Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI) | From enrollment to the end of randomized treatment at 12 weeks |
| Events of clinical bronchospasm | Events of clinical bronchospasm (e.g., treatment-emergent adverse event [TEAE] of wheezing or chest tightness immediately after inhalation) | From enrollment to the end of open-label treatment at 36 weeks |
| FEV1 change | Change in forced expiratory volume in 1 second (FEV1) (mL) | From enrollment to the end of open-label treatment at 36 weeks |
| Spirometry Change | Change in FEV1/forced vital capacity (FVC) ratio | enrollment to end of open label at 36 weeks |
| Study Drug Discontinuation | Rate of study drug discontinuations | From enrollment to the end of open-label treatment at 36 weeks |
| Study Drug Dose Reductions | Rate of study drug dose reductions | From enrollment to the end of open-label treatment at 36 weeks |
| Adverse Events | Rate of TEAEs | From enrollment to the end of open-label treatment at 36 weeks |
| Related Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Nintedanib DPI | To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF. | From enrollment to the end of randomized treatment at 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Therapeutic Area Head, Orphan Lung Dise, MD | Contact | 203-796-3407 | wfares@mannkindcorp.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mannkind Corporation | Danbury | Connecticut | 06810 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
12 weeks parallel treatment followed by 24 weeks open label treatment of nintedanib.
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo oral inhalation powder |
|
Rate of treatment-related adverse events (TRAEs) |
| From enrollment to the end of open-label treatment at 36 weeks |
| Serious Adverse Events | Rate of serious adverse events (SAEs) | From enrollment to the end of open-label treatment at 36 weeks |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided